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The goal of this study is to evaluate the effectiveness of different formulations of bupivacaine infiltrated into the transversus abdominis plane (TAP) on post-operative pain management after open abdominal hysterectomy.
All eligible patients who consent to the study will be randomized to one of three groups. Group 1 will receive a TAP block with 60 mL 0.25% bupivacaine. Group 2 will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline. Group 3 will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine. Patients will be assessed in the post-anesthesia care unit (PACU) at once each on Post-operative day 1,2, and 3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine | Active Comparator | Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine |
|
| Liposomal bupivacaine | Active Comparator | Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline. this group will not receive bupivacaine. they receive only liposomal bupivacaine. |
|
| Liposomal bupivacaine and bupivacaine | Experimental | Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine. this group will receive the mixture of Liposomal bupivacaine and bupivacaine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | 0.25% bupivacaine for TAP block |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg) | Total opioid consumption | 0 - 72 hours post-operatively |
| Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given | time to first opioid given | 0 - 72 hours post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied | Patient satisfaction post-operatively. The number of patients who were very satisfied is reported. | 0 - 72 hours post-operatively |
| Length of Stay in the Hospital |
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Inclusion Criteria:
Exclusion Criteria:
Eligible patients are undergoing open abdominal hysterectomy and therefore are female.
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed-Rida Alsaden, MBChB FRCPC | Henry Ford Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33432496 | Derived | Fidkowski CW, Choksi N, Alsaden MR. A randomized-controlled trial comparing liposomal bupivacaine, plain bupivacaine, and the mixture of liposomal bupivacaine and plain bupivacaine in transversus abdominus plane block for postoperative analgesia for open abdominal hysterectomies. Can J Anaesth. 2021 Jun;68(6):773-781. doi: 10.1007/s12630-020-01911-1. Epub 2021 Jan 11. |
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Individual patient data will be available to only study researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bupivacaine | Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine Bupivacaine: 0.25% bupivacaine for TAP block |
| FG001 | Liposomal Bupivacaine | Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline. this group will not receive bupivacaine. they receive only liposomal bupivacaine. Liposomal bupivacaine: Exparel for TAP block Saline: Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume. |
| FG002 | Liposomal Bupivacaine and Bupivacaine | Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine. this group will receive the mixture of Liposomal bupivacaine and bupivacaine. Bupivacaine: 0.25% bupivacaine for TAP block Liposomal bupivacaine: Exparel for TAP block |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
13 patients were excluded from study analysis due to meeting exclusion criteria. N=25 in group Bupi, N = 27 in group Liposomal bupi, and N=25 in group liposomal bupi and bupi. 20 patients were discharged within 72 hr. Data is given for those in the hospital for 24 hr periods. For the period 24-48 hr, n = 24 in group bupivacaine, n = 26 in group liposomal, n = 25 in group mixture. For the period 48-72 hr, n = 18 for group bupivacaine, n = 20 for group liposomal, and n = 19 for group mixture. *
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| ID | Title | Description |
|---|---|---|
| BG000 | Bupivacaine | Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine Bupivacaine: 0.25% bupivacaine for TAP block |
| BG001 | Liposomal Bupivacaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg) | Total opioid consumption | Posted | Median | Inter-Quartile Range | mg morphine equivalents | 0 - 72 hours post-operatively |
|
72 hours
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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 | Bupivacaine | Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine Bupivacaine: 0.25% bupivacaine for TAP block |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christina Fidkowski, MD | Henry Ford Hospital | 313-916-7648 | cfidkow1@hfhs.org |
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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 | Jun 22, 2016 | Nov 29, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Patients will be randomized to one of three study groups.
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The patient, surgical team, nursing team, anesthesia team, and outcomes assessor will be blinded to the group assignment. The anesthetist performing the TAP block will not be blinded to the group assignment.
| Liposomal bupivacaine | Drug | Exparel for TAP block |
|
|
| Saline | Drug | Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume. |
|
Length of stay in the hospital, maximum time until discharge from the hospital
| until the patient is discharged from the hospital |
| Number of Patients With Local Anesthetic Toxicity | Presence of local anesthetic toxicity | 0 - 72 hours post-operatively |
| Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure | Presence of hemodynamic instability | 0 - 72 hours post-operatively |
| Pain Scores Using Visual Analogue Scale ( 0-10) | Maximum pain score 0 - 24 hr. Pain scores are reported on a scale of 0-10. 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain. | 0-24 postoperative pain scores |
Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline.
this group will not receive bupivacaine. they receive only liposomal bupivacaine.
Liposomal bupivacaine: Exparel for TAP block
Saline: Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.
| BG002 | Liposomal Bupivacaine and Bupivacaine | Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine. this group will receive the mixture of Liposomal bupivacaine and bupivacaine. Bupivacaine: 0.25% bupivacaine for TAP block Liposomal bupivacaine: Exparel for TAP block |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Liposomal Bupivacaine and Bupivacaine | Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine. this group will receive the mixture of Liposomal bupivacaine and bupivacaine. Bupivacaine: 0.25% bupivacaine for TAP block Liposomal bupivacaine: Exparel for TAP block |
|
|
| Primary | Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given | time to first opioid given | Posted | Median | Inter-Quartile Range | minutes | 0 - 72 hours post-operatively |
|
|
|
| Secondary | Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied | Patient satisfaction post-operatively. The number of patients who were very satisfied is reported. | Posted | Number | participants | 0 - 72 hours post-operatively |
|
|
|
| Secondary | Length of Stay in the Hospital | Length of stay in the hospital, maximum time until discharge from the hospital | Posted | Median | Inter-Quartile Range | hours | until the patient is discharged from the hospital |
|
|
|
| Secondary | Number of Patients With Local Anesthetic Toxicity | Presence of local anesthetic toxicity | Posted | Count of Participants | Participants | 0 - 72 hours post-operatively |
|
|
|
| Secondary | Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure | Presence of hemodynamic instability | Posted | Count of Participants | Participants | 0 - 72 hours post-operatively |
|
|
|
| Secondary | Pain Scores Using Visual Analogue Scale ( 0-10) | Maximum pain score 0 - 24 hr. Pain scores are reported on a scale of 0-10. 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain. | Posted | Median | Inter-Quartile Range | units on a scale | 0-24 postoperative pain scores |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Liposomal Bupivacaine | Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline. this group will not receive bupivacaine. they receive only liposomal bupivacaine. Liposomal bupivacaine: Exparel for TAP block Saline: Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume. | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | Liposomal Bupivacaine and Bupivacaine | Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine. this group will receive the mixture of Liposomal bupivacaine and bupivacaine. Bupivacaine: 0.25% bupivacaine for TAP block Liposomal bupivacaine: Exparel for TAP block | 0 | 30 | 0 | 30 | 0 | 30 |
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| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|