Phase 4
Completed N=90
Mixture of Liposomal Bupivacaine and Bupivacaine for TAP Block for Open Hysterectomy
Hysterectomy
Source: ClinicalTrials.gov NCT03250507 ↗
Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcomePrimary: Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg) — 208; 203; 202 mg morphine equivalents
◆ Published Evidence
Established
26citations · ~5 / year
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.
Summary
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.
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg) |
208; 203; 202 | — |
| PRIMARY Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given |
51; 63; 51 | — |
| SECONDARY Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied |
9; 13; 9 | — |
| SECONDARY Length of Stay in the Hospital |
79; 82; 80 | — |
| SECONDARY Number of Patients With Local Anesthetic Toxicity |
0; 0; 0 | — |
| SECONDARY Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure |
0; 1; 5 | — |
| SECONDARY Pain Scores Using Visual Analogue Scale ( 0-10) |
8; 7; 7 | — |
Eligibility Criteria
Inclusion Criteria
- Elective open abdominal hysterectomy with midline incision, age > 18 years, American Society of Anesthesiologist classification score (ASA classification) 1-3.
Exclusion Criteria
- Patient with a chronic pain condition, major unexpected surgical complication, unexpected prolonged intubation, patient refusal, local anesthetic allergy, any contraindication to regional anesthesia, greater than 2 attempts by resident and greater than 1 attempt by staff anesthesiologist for TAP block.
Data sourced from ClinicalTrials.gov (NCT03250507) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.