80 Participants Needed

TAP Block vs Local Anesthetic for Pain Relief After Surgery

CC
Overseen ByCancer Connect
Age: 18+
Sex: Female
Trial Phase: Phase 4
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This study is being done to see if preoperative transversus abdominis plane (TAP) analgesia will provide similar postoperative pain control, hospital length of stay, and postoperative outcomes compared to surgeon-initiated wound infiltration with local anesthetic in participants undergoing laparotomy for gynecologic indications.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have a history of chronic pain disorders or chronic opioid use, you may not be eligible to participate.

What data supports the effectiveness of the treatment TAP Block vs Local Anesthetic for Pain Relief After Surgery?

Research shows that both TAP block and local anesthetic wound infiltration can effectively relieve pain after surgery, but there is no clear evidence that one method is superior to the other. Some studies suggest that TAP block is a reliable technique for pain control, but the benefits over wound infiltration are still debated.12345

Is TAP block or local anesthetic wound infiltration safe for pain relief after surgery?

Both TAP block and local anesthetic wound infiltration are generally considered safe techniques for managing pain after surgery. They are commonly used and have been studied in various trials, showing no significant safety concerns.12356

How does the TAP block treatment differ from local anesthetic wound infiltration for pain relief after surgery?

The TAP block is a novel pain relief method that targets the transversus abdominis plane, providing effective pain control by blocking nerve signals in the abdominal area, whereas local anesthetic wound infiltration involves directly applying anesthetic to the wound site. While both methods aim to reduce postoperative pain, the TAP block is considered a more advanced locoregional technique, although its superiority over traditional wound infiltration remains debated.12456

Research Team

SW

Sumer Wallace, MD

Principal Investigator

UW Carbone Cancer Center

Eligibility Criteria

This trial is for individuals undergoing laparotomy surgery for gynecologic reasons. It's designed to compare two pain management techniques post-surgery. Participants should be eligible for the surgical procedure and not have conditions that would exclude them from safely receiving either of the pain control methods.

Inclusion Criteria

I can have a TAP block and have no allergies to anesthetics or past surgeries that change my belly's structure.
I am having surgery for a gynecological reason through a cut down the middle of my belly at UW Hospital.
I am older than 18 years.
See 3 more

Exclusion Criteria

Patient has a history of opioid dependence requiring rehabilitation or the use of opioid antagonists
I am not scheduled for an exploratory surgery that involves only biopsies.
I have liver disease that prevents me from taking strong painkillers.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Participants receive either TAP analgesia or local anesthetic wound infiltration before surgery

1 day

Postoperative

Participants are monitored for pain control, anti-emetic use, and complications after surgery

up to 60 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Local Anesthetic Wound Infiltration
  • Transversus Abdominis Plane Block
Trial OverviewThe study is testing if a preoperative pain block called TAP anesthesia can provide similar or better post-surgery outcomes compared to local anesthetic applied directly to the wound by the surgeon, in terms of pain control, hospital stay length, and recovery.
Participant Groups
2Treatment groups
Active Control
Group I: Laparotomy plus Local Wound AnestheticActive Control1 Intervention
Group II: TAP Block plus LaparotomyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

Findings from Research

In a multicenter trial involving 102 patients undergoing laparoscopic colorectal surgery, the addition of a transversus abdominis plane (TAP) block to wound infiltration (WI) did not significantly improve pain control at 6 hours post-surgery, with comparable pain scores between the two groups.
The study found no differences in pain management, analgesic consumption, or other short-term outcomes between the TAP block and WI alone, suggesting that TAP block may not provide additional benefits in this context.
Analgesic efficacy of pre-emptive local wound infiltration plus laparoscopic-assisted transversus abdominis plane block versus wound infiltration in patients undergoing laparoscopic colorectal resection: results from a randomized, multicenter, single-blind, non-inferiority trial.Pedrazzani, C., Park, SY., Conti, C., et al.[2021]
In a review of 9 randomized controlled trials involving 500 participants, the transversus abdominis plane (TAP) block was found to provide significantly lower pain scores at 8 and 24 hours post-surgery compared to local anaesthetic wound infiltration.
TAP block also reduced overall morphine consumption by an average of 3.85 mg over 24 hours, indicating it may be a more effective option for postoperative pain management, especially in adults compared to children.
Transversus abdominis plane block versus local anaesthetic wound infiltration for postoperative analgesia: A systematic review and meta-analysis.Guo, Q., Li, R., Wang, L., et al.[2022]
This study aims to compare the effectiveness of wound infiltration (WI) alone versus WI combined with laparoscopic transversus abdominis plane (L-TAP) block for pain management in patients undergoing laparoscopic colorectal surgery, involving a total of 108 patients across two centers.
The primary goal is to determine if L-TAP provides significant pain relief compared to WI alone, with secondary outcomes including the need for additional pain medication, incidence of nausea and vomiting, recovery of gut function, and length of hospital stay.
Analgesic efficacy of preemptive local wound infiltration plus laparoscopic-assisted transversus abdominis plane block versus wound infiltration in patients undergoing laparoscopic colorectal resection: study protocol for a randomized, multicenter, single-blind, noninferiority trial.Pedrazzani, C., Park, SY., Scotton, G., et al.[2020]

References

Analgesic efficacy of pre-emptive local wound infiltration plus laparoscopic-assisted transversus abdominis plane block versus wound infiltration in patients undergoing laparoscopic colorectal resection: results from a randomized, multicenter, single-blind, non-inferiority trial. [2021]
Transversus abdominis plane block versus local anaesthetic wound infiltration for postoperative analgesia: A systematic review and meta-analysis. [2022]
Analgesic efficacy of preemptive local wound infiltration plus laparoscopic-assisted transversus abdominis plane block versus wound infiltration in patients undergoing laparoscopic colorectal resection: study protocol for a randomized, multicenter, single-blind, noninferiority trial. [2020]
The analgesic efficacy of transversus abdominis plane block vs. wound infiltration after inguinal and infra-umbilical hernia repairs: A systematic review and meta-analysis with trial sequential analysis. [2023]
Transversus Abdominis Plane Block versus Wound Infiltration with Conventional Local Anesthetics in Adult Patients Underwent Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2022]
Transversus abdominis-plane block versus local anesthetic wound infiltration in lower abdominal surgery: a systematic review and meta-analysis of randomized controlled trials. [2022]