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The purpose of this study is to compare the difference between two different pain control methods in patients who will be having a colorectal surgery
Quadratus lumborum (QL) blocks will be done intraoperatively after induction. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service.
All patients will receive 1 gm acetaminophen and 600 mg gabapentin preoperatively. Patients above 70yo will receive 300mg gabapentin. Patient will be randomized to one of the two arms.
For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. For the liposomal bupivacaine (LB) group, 0.125% bupivacaine 20ml plus Exparel®10ml will then be injected into the fascial plane on each side. For the standard bupivacaine (SB) group. 30ml 0.25% bupivacaine will be injected on each side. Saline will be used for hydro-dissection until the QL block target is confirmed on ultrasound.
As part of the enhanced recovery after surgery (ERAS) protocol, all patients will receive ketamine and lidocaine drip during surgery, which is the investigator's current standard of practice.
All patients will be scheduled on PO acetaminophen and PO gabapentin daily postoperatively per ERAS protocol. PO oxycodone as needed (PRN) will be started once patients tolerate diet. PRN IV dilaudid may be given for severe breakthrough pain.
Opioid usage at 1, 24, 48 and 72 hours after the block will be recorded by a member of the research team. Pain scores at rest and on movement (knee flexion) will be measured by the investigator using Visual Analog Scale (VAS). Nausea will be measured using a categorical scoring system (none=0; mild=1; moderate=2; severe=3). Sedation scores will also be assessed by a member of the study team using a sedation scale (awake and alert=0; quietly awake=1; asleep but easily roused=2; deep sleep=3). All these parameters will be measured at 1, 24, 48 and 72 hours after the QL block and patients will be encouraged to ambulate on postoperative day 1 under supervision. Their ambulation activity will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivacaine | Active Comparator | LB (Liposomal Bupivacaine) group - This group will be receiving 20 mL EXPAREL (266mg) and 40 mL of 0.125% bupivacaine in total, 30ml on each side. For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane. |
|
| Standard Bupivacaine | Active Comparator | SB (Standard Bupivacaine) group - This group will be receiving 60 mL of 0.25% bupivacaine in total, 30 mL on each side. For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liposomal Bupivacaine | Drug | 20 mL liposomal bupivacaine are injected into the liposomal bupivacaine group |
|
| Measure | Description | Time Frame |
|---|---|---|
| VAS Score at 1 Hour at Rest | The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain | Pain scores will be measured 1 hour after surgery |
| VAS Score at 1 Hour With Movement | The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain | Pain scores will be measured 1 hour after surgery |
| VAS Score at 24 Hours at Rest | The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain | Pain scores will be measured 24 hours after surgery |
| VAS Score at 24 Hours With Movement | The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain | Pain scores will be measured 24 hours after surgery |
| VAS Score at 48 Hours at Rest | The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain | Pain scores will be measured 48 hours after surgery |
| VAS Score at 48 Hours With Movement | The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain |
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Consumption at 1 Hour | Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements | Opioid consumption will be measured at 1 hour post op. The total amount will be recorded |
| Total Opioid Consumption at 24 Hour |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea Scores (None) at 1 Hour | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Nausea scores will be measured at 1 hour post-op. |
| Nausea Scores (Mild) at 1 Hour |
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yar Yeap, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Hospital | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34551581 | Derived | Yeap YL, Wolfe J, Stewart J, McCutchan A, Chawla G, Robb B, Holcomb B, Vickery B. Liposomal bupivacaine addition versus standard bupivacaine alone for colorectal surgery: a randomized controlled trial. Pain Manag. 2022 Jan;12(1):35-43. doi: 10.2217/pmt-2021-0033. Epub 2021 Sep 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liposomal Bupivacaine | LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side. For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane. liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group |
| FG001 | Standard Bupivacaine | SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side. For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane. Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group. 60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Liposomal Bupivacaine | LB (Liposomal Bupivacaine) group - This group will be receiving 20 mL EXPAREL (266mg) and 40 mL of 0.125% bupivacaine in total, 30 mL on each side. For the quadratus lumborum (QL) block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane. liposomal Bupivacaine: 20 mL liposomal bupivacaine are injected into the liposomal bupivacaine group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | VAS Score at 1 Hour at Rest | The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain | Posted | Median | Inter-Quartile Range | score on a scale | Pain scores will be measured 1 hour after surgery |
|
72 hours postoperative
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liposomal Bupivacaine | LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side. For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane. liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yar Luan Yeap | Indiana University | 317-274-0275 | yyeap@iupui.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 30, 2019 | May 6, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Both the patients and the research staff doing assessments will be blinded to the randomization.
| Bupivacaine Hydrochloride | Drug | 40 mL of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group. 60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group |
|
| Pain scores will be measured 48 hours after surgery |
| VAS Score at 72 Hours at Rest | The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain | Pain scores will be measured 72 hours after surgery |
| VAS Score at 72 Hours With Movement | The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain | Pain scores will be measured 72 hours after surgery |
Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements |
| Opioid consumption will be measured at 24 hour post op. The total amount will be recorded |
| Total Opioid Consumption at 48 Hour | Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements | Opioid consumption will be measured at 48 hour post op. The total amount will be recorded |
| Total Opioid Consumption at 72 Hour | Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements | Opioid consumption will be measured at 72 hour post op. The total amount will be recorded |
Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe |
| Nausea scores will be measured at 1 hour post-op. |
| Nausea Scores (Moderate) at 1 Hour | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Nausea scores will be measured at 1 hour post-op. |
| Nausea Scores (Severe) at 1 Hour | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Nausea scores will be measured at 1 hour post-op. |
| Nausea Scores (None) at 24 Hours | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Nausea scores will be measured at 24 hours post-op. |
| Nausea Scores (Mild) at 24 Hours | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Nausea scores will be measured at 24 hours post-op. |
| Nausea Scores (Moderate) at 24 Hours | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Nausea scores will be measured at 24 hours post-op. |
| Nausea Scores (Severe) at 24 Hours | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Nausea scores will be measured at 24 hours post-op. |
| Nausea Scores (None) at 48 Hours | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Nausea scores will be measured at 48 hours post-op. |
| Nausea Scores (Mild) at 48 Hours | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Nausea scores will be measured at 48 hours post-op. |
| Nausea Scores (Moderate) at 48 Hours | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Nausea scores will be measured at 48 hours post-op. |
| Nausea Scores (Severe) at 48 Hours | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Nausea scores will be measured at 48 hours post-op. |
| Nausea Scores (None) at 72 Hours | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Nausea scores will be measured at 72 hours post-op. |
| Nausea Scores (Mild) at 72 Hours | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Nausea scores will be measured at 72 hours post-op. |
| Nausea Scores (Moderate) at 72 Hours | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Nausea scores will be measured at 72 hours post-op. |
| Nausea Scores (Severe) at 72 Hours | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Nausea scores will be measured at 72 hours post-op. |
| Sedation Scores (Awake/Alert) at 1 Hour | Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep. | Sedation scores will be documented at 1 hour post-op. |
| Sedation Scores (Quietly Awake) at 1 Hour | Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep. | Sedation scores will be documented at 1 hour post-op. |
| Sedation Scores (Asleep/Arousable) at 1 Hour | Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep. | Sedation scores will be documented at 1 hour post-op. |
| Sedation Scores (Deep Sleep) at 1 Hour | Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep. | Sedation scores will be documented at 1 hour post-op. |
| Sedation Scores (Awake/Alert) at 24 Hours | Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep. | Sedation scores will be documented at 24 hours post-op. |
| Sedation Scores (Awake/Alert) at 48 Hours | Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep. | Sedation scores will be documented at 48 hours post-op. |
| Sedation Scores (Awake/Alert) at 72 Hours | Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep. | Sedation scores will be documented at 72 hours post-op. |
| Surgery Duration | Duration of surgery will be collected per MR of surgeon documentation. | Duration of Surgery from surgery start time to surgery stop time (usually within 6 hours) |
| Length of Stay | Admission date until Admission Discharge | Time Frame for Admission to Discharge (usually within 3-7 days) |
| Time to Flatus | Hours for End of Surgery to first reported hour of Flatus | End of Surgery until first reported Flatus (usually within 3 to 5 days) |
| Time to Bowel Movement | Hours for End of Surgery to first reported hour of bowel movement | End of Surgery until first reported Bowel movement per MR or patient reported (usually 3 to 5 days) |
| Time to Per Os | Reported time after surgery to time of Os per MR or patient | Time from end of surgery to time of Os (usually 4-16 hours) |
| Ambulatory Postoperatively | Number of patients who ambulated within 24 hours of end of surgery | End of Surgery until first reported ambulated postoperatively per MR or patient reported (Usually within 24 hours postop) |
| BG001 | Standard Bupivacaine | SB (Standard Bupivacaine) group - This group will be receiving 60 mL of 0.25% bupivacaine in total, 30 mL on each side. For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane. Bupivacaine Hydrochloride: 40 mL of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group. 60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body Mass Index | Median | Inter-Quartile Range | kg/square meter |
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| No Known Allergies | Count of Participants | Participants |
|
| Height | Median | Inter-Quartile Range | cm |
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| Weight | Median | Inter-Quartile Range | kg |
|
| OG001 | Standard Bupivacaine | SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side. For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane. Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group. 60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group |
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| Primary | VAS Score at 1 Hour With Movement | The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain | Posted | Median | Inter-Quartile Range | score on a scale | Pain scores will be measured 1 hour after surgery |
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| Primary | VAS Score at 24 Hours at Rest | The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain | Posted | Median | Inter-Quartile Range | score on a scale | Pain scores will be measured 24 hours after surgery |
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| Primary | VAS Score at 24 Hours With Movement | The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain | Posted | Median | Inter-Quartile Range | score on a scale | Pain scores will be measured 24 hours after surgery |
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| Primary | VAS Score at 48 Hours at Rest | The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain | Posted | Median | Inter-Quartile Range | score on a scale | Pain scores will be measured 48 hours after surgery |
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| Primary | VAS Score at 48 Hours With Movement | The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain | Posted | Median | Inter-Quartile Range | score on a scale | Pain scores will be measured 48 hours after surgery |
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| Primary | VAS Score at 72 Hours at Rest | The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain | Posted | Median | Inter-Quartile Range | score on a scale | Pain scores will be measured 72 hours after surgery |
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| Primary | VAS Score at 72 Hours With Movement | The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain | Posted | Median | Inter-Quartile Range | score on a scale | Pain scores will be measured 72 hours after surgery |
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| Secondary | Total Opioid Consumption at 1 Hour | Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements | Posted | Median | Inter-Quartile Range | morphine equivalent units | Opioid consumption will be measured at 1 hour post op. The total amount will be recorded |
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| Secondary | Total Opioid Consumption at 24 Hour | Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements | Posted | Median | Inter-Quartile Range | morphine equivalent units | Opioid consumption will be measured at 24 hour post op. The total amount will be recorded |
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| Secondary | Total Opioid Consumption at 48 Hour | Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements | Posted | Median | Inter-Quartile Range | morphine equivalent units | Opioid consumption will be measured at 48 hour post op. The total amount will be recorded |
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| Secondary | Total Opioid Consumption at 72 Hour | Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements | Posted | Median | Inter-Quartile Range | morphine equivalent units | Opioid consumption will be measured at 72 hour post op. The total amount will be recorded |
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| Other Pre-specified | Nausea Scores (None) at 1 Hour | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Posted | Count of Participants | Participants | Nausea scores will be measured at 1 hour post-op. |
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| Other Pre-specified | Nausea Scores (Mild) at 1 Hour | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Posted | Count of Participants | Participants | Nausea scores will be measured at 1 hour post-op. |
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| Other Pre-specified | Nausea Scores (Moderate) at 1 Hour | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Posted | Count of Participants | Participants | Nausea scores will be measured at 1 hour post-op. |
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| Other Pre-specified | Nausea Scores (Severe) at 1 Hour | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Posted | Count of Participants | Participants | Nausea scores will be measured at 1 hour post-op. |
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| Other Pre-specified | Nausea Scores (None) at 24 Hours | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Posted | Count of Participants | Participants | Nausea scores will be measured at 24 hours post-op. |
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| Other Pre-specified | Nausea Scores (Mild) at 24 Hours | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Posted | Count of Participants | Participants | Nausea scores will be measured at 24 hours post-op. |
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| Other Pre-specified | Nausea Scores (Moderate) at 24 Hours | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Posted | Count of Participants | Participants | Nausea scores will be measured at 24 hours post-op. |
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| Other Pre-specified | Nausea Scores (Severe) at 24 Hours | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Posted | Count of Participants | Participants | Nausea scores will be measured at 24 hours post-op. |
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| Other Pre-specified | Nausea Scores (None) at 48 Hours | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Posted | Count of Participants | Participants | Nausea scores will be measured at 48 hours post-op. |
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| Other Pre-specified | Nausea Scores (Mild) at 48 Hours | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Posted | Count of Participants | Participants | Nausea scores will be measured at 48 hours post-op. |
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| Other Pre-specified | Nausea Scores (Moderate) at 48 Hours | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Posted | Count of Participants | Participants | Nausea scores will be measured at 48 hours post-op. |
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| Other Pre-specified | Nausea Scores (Severe) at 48 Hours | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Posted | Count of Participants | Participants | Nausea scores will be measured at 48 hours post-op. |
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| Other Pre-specified | Nausea Scores (None) at 72 Hours | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Posted | Count of Participants | Participants | Nausea scores will be measured at 72 hours post-op. |
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| Other Pre-specified | Nausea Scores (Mild) at 72 Hours | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Posted | Count of Participants | Participants | Nausea scores will be measured at 72 hours post-op. |
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| Other Pre-specified | Nausea Scores (Moderate) at 72 Hours | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Posted | Count of Participants | Participants | Nausea scores will be measured at 72 hours post-op. |
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| Other Pre-specified | Nausea Scores (Severe) at 72 Hours | Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as none, mild, moderate, or severe | Posted | Count of Participants | Participants | Nausea scores will be measured at 72 hours post-op. |
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| Other Pre-specified | Sedation Scores (Awake/Alert) at 1 Hour | Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep. | Posted | Count of Participants | Participants | Sedation scores will be documented at 1 hour post-op. |
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| Other Pre-specified | Sedation Scores (Quietly Awake) at 1 Hour | Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep. | Posted | Count of Participants | Participants | Sedation scores will be documented at 1 hour post-op. |
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| Other Pre-specified | Sedation Scores (Asleep/Arousable) at 1 Hour | Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep. | Posted | Count of Participants | Participants | Sedation scores will be documented at 1 hour post-op. |
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| Other Pre-specified | Sedation Scores (Deep Sleep) at 1 Hour | Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep. | Posted | Count of Participants | Participants | Sedation scores will be documented at 1 hour post-op. |
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| Other Pre-specified | Sedation Scores (Awake/Alert) at 24 Hours | Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep. | Posted | Count of Participants | Participants | Sedation scores will be documented at 24 hours post-op. |
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| Other Pre-specified | Sedation Scores (Awake/Alert) at 48 Hours | Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep. | Posted | Count of Participants | Participants | Sedation scores will be documented at 48 hours post-op. |
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| Other Pre-specified | Sedation Scores (Awake/Alert) at 72 Hours | Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep. | Posted | Count of Participants | Participants | Sedation scores will be documented at 72 hours post-op. |
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| Other Pre-specified | Surgery Duration | Duration of surgery will be collected per MR of surgeon documentation. | Posted | Median | Inter-Quartile Range | minutes | Duration of Surgery from surgery start time to surgery stop time (usually within 6 hours) |
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| Other Pre-specified | Length of Stay | Admission date until Admission Discharge | Posted | Median | Inter-Quartile Range | days | Time Frame for Admission to Discharge (usually within 3-7 days) |
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| Other Pre-specified | Time to Flatus | Hours for End of Surgery to first reported hour of Flatus | Posted | Median | Inter-Quartile Range | hours | End of Surgery until first reported Flatus (usually within 3 to 5 days) |
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| Other Pre-specified | Time to Bowel Movement | Hours for End of Surgery to first reported hour of bowel movement | Posted | Median | Inter-Quartile Range | hours | End of Surgery until first reported Bowel movement per MR or patient reported (usually 3 to 5 days) |
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| Other Pre-specified | Time to Per Os | Reported time after surgery to time of Os per MR or patient | Posted | Median | Inter-Quartile Range | hours | Time from end of surgery to time of Os (usually 4-16 hours) |
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| Other Pre-specified | Ambulatory Postoperatively | Number of patients who ambulated within 24 hours of end of surgery | Posted | Count of Participants | Participants | End of Surgery until first reported ambulated postoperatively per MR or patient reported (Usually within 24 hours postop) |
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| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Standard Bupivacaine | SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side. For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane. Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group. 60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group | 0 | 40 | 0 | 40 | 0 | 40 |
Not provided
Not provided
Not provided
| D000588 |
| Amines |