TAP Block vs Local Anesthetic for Pain Relief After Surgery

Overseen By Cancer Connect

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Wisconsin, Madison

Must not be taking: Opioids, Opioid antagonists

Disqualifiers: Chronic pain, Opioid dependence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods for managing pain after gynecologic surgery: a TAP block (a type of nerve block) and local anesthetic applied directly to the wound. Researchers aim to determine if the TAP block offers similar pain relief and recovery outcomes as the local anesthetic. Individuals undergoing a laparotomy for gynecologic reasons, without previous major abdominal surgery, might be suitable for this trial. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, allowing researchers to understand its benefits for more patients.

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 is the safety track record for these treatments?

Research has shown that both the Transversus Abdominis Plane (TAP) block and local anesthetic wound infiltration are generally safe and well-tolerated.

Studies have found the TAP block effective in reducing the need for pain medication after surgery, specifically decreasing morphine use in the first 24 to 48 hours post-surgery. This indicates it manages pain well without causing major issues.

Local anesthetic wound infiltration is also considered safe and is a straightforward method for managing post-surgical pain. Research has demonstrated that it effectively reduces pain and helps patients recover and leave the hospital more quickly.

Both treatments have been used in various surgeries and have shown positive safety records. Prospective trial participants can be reassured by the safety of these methods for many patients. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about comparing the Transversus Abdominis Plane (TAP) Block and Local Anesthetic Wound Infiltration for pain relief after surgery. Unlike the standard local anesthetic infiltration, which involves directly injecting anesthetic into the surgical wound area, the TAP Block targets nerves in the abdominal wall, potentially offering broader and longer-lasting pain relief. This method could reduce the need for opioids post-surgery, addressing concerns about opioid side effects and dependency. By exploring these techniques, researchers hope to find a more effective and safer way to manage postoperative pain.

What evidence suggests that this trial's treatments could be effective for pain relief after surgery?

This trial will compare the effectiveness of TAP blocks and local anesthetic wound infiltration for pain relief after surgery. Research has shown that both methods help reduce postoperative pain. Studies indicate that TAP blocks can significantly lower pain levels and decrease the need for painkillers after abdominal surgeries, particularly immediately following the operation. Local anesthetic wound infiltration also effectively reduces pain and can speed recovery by numbing the wound area and reducing swelling and redness. Both methods are part of a broader plan to manage pain effectively. ^{2 3 5 6 7}

Who Is on the Research Team?

Sumer Wallace, MD

Principal Investigator

UW Carbone Cancer Center

Are You a Good Fit for This Trial?

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.

English speaking (able to provide consent and complete questionnaires)

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Local Anesthetic Wound Infiltration
• Transversus Abdominis Plane Block

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.

How Is the Trial Designed?

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

Group II: TAP Block plus Laparotomy Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

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. Pedrazzani, C., Park, SY., Scotton, G., et al.[2020]

A meta-analysis of four randomized controlled trials involving 196 patients showed that the transversus abdominis plane (TAP) block significantly reduced postoperative pain scores at 24 hours compared to local anesthetic infiltration (LAI), indicating better long-lasting pain relief.

Both TAP block and LAI resulted in similar morphine requirements and rates of postoperative nausea and vomiting, suggesting that while TAP block offers superior pain management, both methods are effective for short-term analgesia.

NCBI (Pubmed)

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. Yu, N., Long, X., Lujan-Hernandez, JR., et al.[2022]

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.

NCBI (Pubmed)

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. 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A systematic review of 7 trials involving 420 patients found that the transversus abdominis plane (TAP) block significantly reduces rest pain scores at 2 hours post-surgery compared to local anaesthetic wound infiltration, indicating better immediate pain relief.

TAP block also showed improvements in secondary pain-related outcomes without any reported complications, suggesting it is a safe and effective analgesic option after inguinal or infra-umbilical hernia repair.

NCBI (Pubmed)

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. Grape, S., Kirkham, KR., Albrecht, E.[2023]

A systematic review of 15 studies involving 983 participants found that the transversus abdominis plane (TAP) block provides a more effective and consistent pain relief compared to wound infiltration (WI) with conventional local anesthetics in adult patients after surgery.

While WI showed similar analgesic effects to TAP block only at the one-hour postoperative mark, it resulted in a quicker need for rescue analgesics and lower patient satisfaction, highlighting TAP block as the superior method for managing postoperative pain.

NCBI (Pubmed)

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. Cai, Q., Gao, ML., Chen, GY., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4053826/

Efficacy of Postoperative Continuous Wound Infiltration With ... Conclusions: Surgical wound infusion with ropivacaine after hepatectomy can improve pain relief at rest and accelerate recovery and discharge. Key Words: local ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22260370/

Wound infiltration with local anesthetics for post-operative ... In six out of 12 comparisons, the local anesthetic infiltration significantly reduced the supplemental opioid consumption after surgery. Observed reductions in ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0304395909001377

Relief of postoperative pain by local anaesthetic infiltration Due to the local application, transmission of pain from the wound is reduced, and the local inflammatory response to the injury is suppressed.

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/44/NCT02829944/Prot_SAP_001.pdf

Impact of local anesthetic wound infiltration on ... In the general surgical population, a systematic review reported that local anesthetic wound infiltration catheters were effective in reducing ...

5. mdpi.com mdpi.com/2077-0383/10/20/4659

Updates on Wound Infiltration Use for Postoperative Pain ... Local anesthetic wound infiltration (WI) provides anesthesia for minor surgical procedures and improves postoperative analgesia as part of multimodal analgesia.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6999584/

Continuous Wound Infiltration of Local Anesthetics in ... Local infiltration and continuous infusion of surgical wound with anesthetics are parts of multimodal analgesia for postoperative pain control.

7. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2778438

Postoperative Pain Treatment With Continuous Local ... Continuous anesthetic wound infusion is associated with reduced postoperative pain and decreased demand for analgesics.