Post-operative Pain
Conditions
Keywords
Cesarean delivery, post-operative pain, TAP block
Brief summary
The aim of this study is to perform a randomized trial to investigate if intraoperative surgeon administered TAP block reduces pain and use of oral and parenteral pain medications after repeat cesarean delivery. The investigators aim to compare surgeon administered TAP block with liposomal bupivacaine compared to standard treatment (i.e. no TAP block) with regard to the primary outcome of post-operative narcotic use.
Detailed description
Transversus abdominis plane (TAP) block is a well-described technique to provide a field block for analgesia. It has been shown to be effective in postoperative analgesia after cesarean delivery. TAP blocks are commonly performed post-operatively by anesthesiologists using liposomal bupivacaine with ultrasound guidance. Liposomal bupivacaine is an FDA approved medication for post-surgical analgesia and available at UMass-Memorial Medical Center. Liposomal bupivacaine provides sustained release of medication for up to 120 hours. A recent multicenter randomized controlled trial demonstrated the efficacy of anesthesiologist administered TAP blocks using liposomal bupivacaine after cesarean delivery. Infiltration of the skin and fascia with liposomal bupivacaine after cesarean did not have an effect and this can be explained by the path that the pain fibers take through the TAP which makes them amenable to a TAP block while a superficial infiltration is ineffective.The aim of this study is to perform a randomized trial to investigate if intraoperative surgeon administered TAP block reduces pain and use of oral and parenteral pain medications after repeat cesarean delivery. The investigators aim to compare surgeon administered TAP block with liposomal bupivacaine compared to standard treatment (i.e. no TAP block) with regard to the primary outcome of post-operative narcotic use.
Interventions
PROCEDURETAP Block Group
Participants will receive a surgeon administered TAP block.
Sponsors
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women presenting for elective repeat cesarean delivery at 37-42 weeks gestational age. * Pregnancy and delivery care obtained at UMass Memorial Medical Center * Patients able to provide written informed consent * English, Spanish, or Portuguese-speaking patients
Exclusion criteria
* Participants who are under the age of 18 years * Active labor. * Baseline pain score \> 6. * Unable to provide informed consent. * Prisoners will be excluded from this research. * Narcotic use in the 2 weeks prior to delivery. * Active substance abuse. * Inability to take narcotic analgesia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Narcotic Use in Morphine Equivalents | From time of surgery through postpartum day 4 | Daily Narcotic Use in Morphine Equivalents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first administered narcotic (oral or parental) | From time of surgery through postpartum day 4 | Time to first administered narcotic (oral or parental) post cesarean delivery |
| Daily Average Pain Score | From time of surgery through postpartum day 4 | Daily Average Pain Score based on ten point pain scale (minimum 0, maximum 10) with higher numbers indicating worse pain |
| Daily Maximum Pain Score | From time of surgery through postpartum day 4 | Daily Average Pain Score based on ten point pain scale (minimum 0, maximum 10) with higher numbers indicating worse pain |
| Time to First Ambulation | From time of surgery through postpartum day 4 | Time to First Ambulation post cesarean delivery |
| Time to First Solid Food | From time of surgery through postpartum day 4 | Time to First Solid Food |
Outcome results
None listed