TAP Block vs Local Anesthetic for Pain Relief After Surgery

Recruiting in Palo Alto (17 mi)

Overseen by Sumer Wallace, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of Wisconsin, Madison

Must not be taking: Opioids, Opioid antagonists

Disqualifiers: Chronic pain, Opioid dependence, others

No Placebo Group

Prior Safety Data

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. ^{1 2 3 4 5}

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. ^{1 2 3 5 6}

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. ^{1 2 4 5 6}

Research Team

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.

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.

Trial 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 (Procedure)
• Transversus Abdominis Plane Block (Procedure)

Trial Overview The 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

Group I: Laparotomy plus Local Wound Anesthetic Active Control 1 Intervention

Group II: TAP Block plus Laparotomy Active Control 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Wisconsin Hospitals and Clinics (UWHC) Madison, WI

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1249

Patients Recruited

3,255,000+

References

1. Germany pubmed.ncbi.nlm.nih.gov

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]

2. United States pubmed.ncbi.nlm.nih.gov

Transversus abdominis plane block versus local anaesthetic wound infiltration for postoperative analgesia: A systematic review and meta-analysis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

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]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. United States pubmed.ncbi.nlm.nih.gov

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]

6. England pubmed.ncbi.nlm.nih.gov

Transversus abdominis-plane block versus local anesthetic wound infiltration in lower abdominal surgery: a systematic review and meta-analysis of randomized controlled trials. [2022]