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| Name | Class |
|---|---|
| Pacira Pharmaceuticals, Inc | INDUSTRY |
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The purpose of this study is to determine if using a different type of injection of local anesthestic (pain medicine) in between the muscle layers of the abdominal wall (called a quadratus lumborum block) will improve pain control and be easier to manage after surgery than the current standard of care epidural (spinal injection) pain relief for patients undergoing laparoscopy colectomy.
Participants in this study will receive exparel via an abdominal muscle nerve block procedure immediately prior to their operation. Participants will be in this study for 96 hours following surgery, which is typically 3 days. During participation, the study staff will review participant's electronic health records for pain scores and pain medication needs.
Participants that receive the quadratus lumborum block, may experience improved pain control and/or reduced side effects compared to the epidural pain relief option, but it is not known yet whether this will be the case.
The most common risk is being sore in the flank where the block was placed. Other risks of the block rarely occur (less than .5-1%), these can include infection, allergy to the local anesthetic, bleeding, damage to the nerve, seizures, abnormal heart rhythms, and cardiac arrest.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quadratus lumborum block | Experimental | Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles. |
|
| Thoracic epidural analgesia | Other | Historical cohort that received thoracic epidural analgesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel | Drug | Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Opioid Consumption Over 48 Hours | Measured in morphine milligram equivalents. | From arrival to PACU to 48 hours post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11) | The NRS-11 is an 11-point scale where 10=worst pain imaginable and 0= no pain. | 30 minutes after arrival to Post-Anesthesia Care Unit (PACU), and at 8 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours and 168 hours post Exparel administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Block Success | Presence of demonstrable sensory block over 4 points on the abdomen (one in each of the 4 quadrants), as tested by response to pinprick. Subjects will be asked to report whether the stimulus feels "sharp" or "dull", indicating block failure and success respectively. | 30 minutes after arrival to PACU, 8 hours, 24 hours, 36 hours, 48 hours and 72 hours post Exparel administration |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda Kumar, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
Historical Controls were not considered enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Quadratus Lumborum Block | Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL (quadratus lumborum) and psoas major muscles. Exparel: Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles. |
| FG001 | Thoracic Epidural Analgesia | Historical cohort that received thoracic epidural analgesia. Thoracic epidural analgesia: Historical cohort that received thoracic epidural analgesia |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Quadratus Lumborum Block | Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles. Exparel: Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles. |
| 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 | Cumulative Opioid Consumption Over 48 Hours | Measured in morphine milligram equivalents. | Posted | Median | Inter-Quartile Range | morphine milligram equivalents | From arrival to PACU to 48 hours post-operatively |
|
From arrival to PACU to postoperative day 7
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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 | Quadratus Lumborum Block | Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles. Exparel: Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extended hospital stay due to left lower extremity numbness | Nervous system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda Kumar, MD | Duke University | 919-681-6437 | amanda.kumar@duke.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 | Sep 27, 2022 | Jun 22, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013662 | Tea |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
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Compare efficacy of a quadratus lumborum block performed with liposomal bupivacaine for pain relief after laparoscopic colectomy compared to a historical cohort who received thoracic epidural analgesia.
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| Thoracic epidural analgesia | Other | Historical cohort that received thoracic epidural analgesia |
|
| Number of Participants With Adverse Events Related to the Block | Subjects will be evaluated for potential adverse events related to the block including evidence of hematoma, infection, unexpected sensory or motor deficit, local anesthetic systemic toxicity, as well as transient weakness of the hip flexor muscles (a known possible side-effect of QL block). | From administration of Exparel through 168 hours post Exparel administration |
| Satisfaction With Postoperative Pain Control | Overall subject satisfaction with pain control will be recorded on an 11-point scale: 10=highly satisfied, 0=completely unsatisfied. | Up to 48 hours post Exparel administration |
| Hospital Length of Stay | Measured both by raw length of stay and by time to achieving "discharge readiness", defined by the presence of 3 criteria: a pain score of 3 or less with ambulation, no opioids required in the preceding 6 hours, and the ability to perform self-care (go to the toilet, dress, and shower). | From administration of Exparel through hospital discharge |
| Number of Participants With Opioid-related Adverse Events | Adverse events include nausea, vomiting, ileus, constipation, orthostasis, pruritis, urinary retention, respiratory depression. | From administration of Exparel through 168 hours post Exparel administration |
| Time to First Mobilization | From time of arrival in PACU through first mobilization |
| Cost | Hospital costs including pharmacy-related costs, costs due to opioid-related adverse events, the cost associated with nursing interventions and drugs to treat opioid-related adverse events, and overall hospital admission costs will be calculated. | From time of arrival in PACU through 96 hours post Exparel administration |
| Sleep Quality as Measured by Two Questions | Each question has a scale of 0 (no interference) to 10 (completely interferes) and the two scores are averaged: "How much did pain interfere with falling asleep?", "How much did pain interfere with staying asleep?" | Up to 168 hours post Exparel administration |
| BG001 | Thoracic Epidural Analgesia | Historical cohort that received thoracic epidural analgesia. Thoracic epidural analgesia: Historical cohort that received thoracic epidural analgesia |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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Historical cohort that received thoracic epidural analgesia.
Thoracic epidural analgesia: Historical cohort that received thoracic epidural analgesia
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|
| Secondary | Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11) | The NRS-11 is an 11-point scale where 10=worst pain imaginable and 0= no pain. | Data not collected at 144 hours or 168 hours. | Posted | Median | Inter-Quartile Range | score on a scale | 30 minutes after arrival to Post-Anesthesia Care Unit (PACU), and at 8 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours and 168 hours post Exparel administration |
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| Other Pre-specified | Number of Participants With Block Success | Presence of demonstrable sensory block over 4 points on the abdomen (one in each of the 4 quadrants), as tested by response to pinprick. Subjects will be asked to report whether the stimulus feels "sharp" or "dull", indicating block failure and success respectively. | Posted | Count of Participants | Participants | 30 minutes after arrival to PACU, 8 hours, 24 hours, 36 hours, 48 hours and 72 hours post Exparel administration |
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|
|
| Other Pre-specified | Number of Participants With Adverse Events Related to the Block | Subjects will be evaluated for potential adverse events related to the block including evidence of hematoma, infection, unexpected sensory or motor deficit, local anesthetic systemic toxicity, as well as transient weakness of the hip flexor muscles (a known possible side-effect of QL block). | Posted | Count of Participants | Participants | From administration of Exparel through 168 hours post Exparel administration |
|
|
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| Other Pre-specified | Satisfaction With Postoperative Pain Control | Overall subject satisfaction with pain control will be recorded on an 11-point scale: 10=highly satisfied, 0=completely unsatisfied. | Not applicable to the historical thoracic epidural analgesia group. | Posted | Median | Inter-Quartile Range | score on a scale | Up to 48 hours post Exparel administration |
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|
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| Other Pre-specified | Hospital Length of Stay | Measured both by raw length of stay and by time to achieving "discharge readiness", defined by the presence of 3 criteria: a pain score of 3 or less with ambulation, no opioids required in the preceding 6 hours, and the ability to perform self-care (go to the toilet, dress, and shower). | Posted | Median | Inter-Quartile Range | hours | From administration of Exparel through hospital discharge |
|
|
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| Other Pre-specified | Number of Participants With Opioid-related Adverse Events | Adverse events include nausea, vomiting, ileus, constipation, orthostasis, pruritis, urinary retention, respiratory depression. | Posted | Count of Participants | Participants | From administration of Exparel through 168 hours post Exparel administration |
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| Other Pre-specified | Time to First Mobilization | Posted | Median | Inter-Quartile Range | hours | From time of arrival in PACU through first mobilization |
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| Other Pre-specified | Cost | Hospital costs including pharmacy-related costs, costs due to opioid-related adverse events, the cost associated with nursing interventions and drugs to treat opioid-related adverse events, and overall hospital admission costs will be calculated. | Data not collected. | Posted | From time of arrival in PACU through 96 hours post Exparel administration |
|
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| Other Pre-specified | Sleep Quality as Measured by Two Questions | Each question has a scale of 0 (no interference) to 10 (completely interferes) and the two scores are averaged: "How much did pain interfere with falling asleep?", "How much did pain interfere with staying asleep?" | Not applicable to the historical thoracic epidural analgesia group. | Posted | Median | Inter-Quartile Range | score on a scale | Up to 168 hours post Exparel administration |
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| 0 |
| 30 |
| 1 |
| 30 |
| 10 |
| 30 |
| EG001 | Thoracic Epidural Analgesia | Historical cohort that received thoracic epidural analgesia. Thoracic epidural analgesia: Historical cohort that received thoracic epidural analgesia | 0 | 30 | 0 | 30 | 19 | 30 |
| Orthostasis | Cardiac disorders | Non-systematic Assessment |
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| Pruritis | Nervous system disorders | Non-systematic Assessment |
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| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
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| Unexpected sensory deficit | Nervous system disorders | Non-systematic Assessment |
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| Hip flexor weakness | Nervous system disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Ileus | Gastrointestinal disorders | Non-systematic Assessment |
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| Respiratory depression | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| 8 hours |
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| 24 hours |
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| 36 hours |
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| 48 hours |
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| 72 hours |
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| 96 hours |
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| 120 hours |
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| 144 hours |
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| 168 hours |
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