N/A
N=209
Exparel Transversus Abdominis Plane Block vs Intrathecal Analgesia In Colorectal Surgery
Conditions Requiring Colorectal Surgery
Bottom Line
View on ClinicalTrials.gov: NCT02356198 ↗Enrolled (actual)
209
Serious AEs
4.0%
Results posted
Feb 2019
Primary outcome: Primary: Mean Pain Score — 3.0; 2.4 score on a scale — p=0.007
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EXPAREL (Drug); Intrathecal hydromorphone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Pain Score |
3.0; 2.4 | 0.007 sig |
| PRIMARY Total Morphine Milligram Equivalents Use (MME) |
47.5; 32.5 | 0.102 |
| SECONDARY Total Length of Hospital Stay |
3; 3 | 0.85 |
| SECONDARY Number of Participants With Post-operative Ileus |
11; 14 | 0.454 |
| SECONDARY Use of Intravenous Patient-controlled Analgesia |
5; 1 | 0.212 |
Summary
This study is prospective, randomized trial in which EXPAREL TAP block is compared to standard IT opioid administration, in relieving postoperative pain, decreasing length of stay, and use of narcotic medication.
Eligibility Criteria
Inclusion Criteria
- • All patients undergoing elective laparoscopic or open colorectal resections who are eligible for IT
- Age >18 years
- BMI <40
- Ability to understand and read English
Exclusion Criteria
- • Not able or unwilling to sign consent.
- Currently pregnant or lactating.
- Patients with chronic pain, requiring daily opiate use at time of surgery.
- Patients intolerant of opiates, NSAIDS, acetaminophen or local anesthetics.
- Patients requiring emergent surgery.
- Abdominoperineal resections
- Any contraindications to neuraxial analgesia (coagulopathy, localized infection at the potential site of injection, pre-existing spinal canal pathology)
- Patients with a diagnosis of inflammatory bowel disease
Data sourced from ClinicalTrials.gov (NCT02356198). 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.