Bupivacaine TAP Block for Postoperative Pain in C-Section
(COMFORT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a bupivacaine TAP block, a numbing injection given during surgery, can reduce the need for opioid pain medication after a C-section in complex cases. It compares bupivacaine to a placebo (a non-active treatment) to determine if it better manages pain. The trial seeks participants who have had previous complex abdominal surgeries or multiple C-sections. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research aims to understand how it can benefit more patients.
What is the safety track record for bupivacaine?
Research has shown that bupivacaine, when used in a transversus abdominis plane (TAP) block, is generally well-tolerated for managing pain after cesarean deliveries. Studies have demonstrated that it effectively reduces pain and decreases the need for opioid pain medications, which often cause side effects. For instance, one study found that a TAP block with bupivacaine significantly reduced post-surgery pain in patients who had a C-section.
This treatment has been used for some time and is already approved for other types of pain management, which adds confidence in its safety. However, like any treatment, it can have side effects, though serious ones are rare. Common side effects might include temporary numbness or soreness at the injection site. Overall, evidence supports that bupivacaine in TAP blocks is safe and effective for most people, offering a reliable option to manage pain after surgery.12345Why are researchers enthusiastic about this study treatment?
Unlike the standard treatments for postoperative pain after a C-section, which often involve oral medications like opioids or NSAIDs, the bupivacaine TAP block is unique because it provides targeted pain relief directly to the nerve area. Bupivacaine is a local anesthetic that works by blocking nerve signals in the Transversus Abdominis Plane, potentially offering effective pain management with fewer systemic side effects. Researchers are excited because this method might reduce the need for opioids, decreasing the risk of associated side effects and promoting faster recovery for new mothers.
What is the effectiveness track record for Bupivacaine in reducing postoperative pain for C-section patients?
Research has shown that using bupivacaine in a TAP block can greatly improve pain management after a C-section. This trial will compare the effectiveness of bupivacaine TAP blocks with a placebo TAP block. Specifically, one study found that patients who received a bupivacaine TAP block needed fewer opioids and experienced less pain after surgery, suggesting that bupivacaine effectively controls pain and aids recovery after a cesarean delivery. The medical community considers bupivacaine TAP blocks a helpful option for managing pain after a C-section.12467
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intraoperative transversus abdominis plane (TAP) blocks with either bupivacaine or placebo during cesarean delivery
Follow-up
Participants are monitored for pain medication usage and recovery outcomes postoperatively
Long-term Follow-up
Participants are assessed for unplanned postoperative visits and functional recovery
What Are the Treatments Tested in This Trial?
Interventions
- Bupivacaine
- Placebo
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
TAP (Transversus Abdominis Plane) blocks will include 0.5% bupivacaine in 30mL solution of 15mL normal saline and 15mL bupivacaine.
Placebo group TAP (Transversus Abdominis Plane) block syringe will include 30mL normal saline.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Tennessee
Lead Sponsor
Regional One Health
Collaborator
Citations
Transversus Abdominis Plane Block Following Cesarean ...
This study aims to evaluate and compare the effects on pain levels of bupivacaine alone versus bupivacaine combined with dexmedetomidine and bupivacaine ...
Transversus Abdominis Plane Block Following Cesarean ...
This study aims to evaluate and compare the effects on pain levels of bupivacaine alone versus bupivacaine combined with dexmedetomidine and ...
Recovery quality of transversus abdominis plane block with ...
This study aimed to investigate the effect of liposomal bupivacaine in transversus abdominis plane block (TAP) on recovery quality after cesarean delivery.
Transversus abdominis plane block with liposomal ...
This systematic review and meta-analysis evaluated the effect of incorporating liposomal bupivacaine into TAP blocks in patients undergoing cesarean delivery.
Effectiveness of Transversus Abdominis Plane Block in ...
The transversus abdominis plane (TAP) block significantly improved postoperative analgesia in cesarean section patients, as demonstrated by reduced opioid ...
Transverse Abdominis Plane (TAP) Block After Cesarean ...
Studies comparing ropivacaine with bupivacaine for use in interscalene, femoral, or sciatic nerve blocks have found no difference in terms of potency, time to ...
The efficacy of transversus abdominis plane block for post ...
The USG-TAP block with 0.25% bupivacaine 60 ml (30 ml on each side) significantly reduced post-operative pain in patients undergoing the cesarean section. We ...
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