N/A
N=514
Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine
Pain, Postoperative · Major Abdominal Surgery
Bottom Line
View on ClinicalTrials.gov: NCT02996227 ↗Enrolled (actual)
514
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: VRS Pain Score — 4.3; 4.2 score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TAP block (Procedure); Epidural analgesia (Procedure); EXPAREL (Drug); Bupivacaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY VRS Pain Score |
4.3; 4.2 | <0.001 sig |
| PRIMARY Total Opioid Consumption |
56; 35 | 0.754 |
| SECONDARY Cumulative Duration of Activity |
1.1; 1.0 | 0.560 |
| SECONDARY Opioid-related Side Effect |
5.8; 5.5; 4.9; 4.5; 3.8; 3.7 | 0.357 |
| SECONDARY Hemodynamic Instability, Defined as Mean Arterial Pressure (MAP) <55 mmHg or Systolic Blood Pressure <80 mmHg. |
41; 57 | 0.006 sig |
| SECONDARY Quality of Recovery After Anesthesia |
102; 100; 111; 111 | 0.695 |
| SECONDARY Length of Hospital Stay |
4.0; 4.0 | 0.738 |
Summary
Comparison of Bilateral Transversus Abdominis Plane Block with Exparel versus Continuous Epidural Analgesia With Bupivacaine
Eligibility Criteria
Inclusion Criteria
- Written informed consent
- 18-85 years old
- ASA Physical Status 1-3
- Scheduled for elective open or laparoscopic abdominal surgery, including colorectal and hysterectomy surgeries
- Anticipated hospitalization of three nights
- Expected requirement for parenteral opioids for at least 72 hours for postoperative pain
- Able to use IV PCA systems.
Exclusion Criteria
- Hepatic disease, e.g. twice the normal levels of liver enzymes
- Kidney disease, e.g. twice the normal level of serum creatinine
- Bupivacaine sensitivity or known allergy
- Women who are pregnant or breastfeeding
- Anticoagulants considered to be a contraindication for epidural or TAP blocks.
- Surgeries with high port sites will be excluded
Data sourced from ClinicalTrials.gov (NCT02996227). 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.