TAP Blocks for Postoperative Pain

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: McMaster University

Must not be taking: Opioids

Disqualifiers: Revisional surgery, Chronic pain, 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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Surgery duration

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal timing for administering a TAP block, a type of pain relief, during weight-loss surgery. Researchers are investigating whether starting the TAP block at the beginning of surgery reduces pain and the need for opioids post-surgery more effectively than administering it at the end. The trial targets individuals undergoing their first bariatric surgery, such as sleeve gastrectomy or gastric bypass, who have no history of chronic pain or opioid use. This approach could potentially lead to faster recovery and reduced reliance on pain medications. As a Phase 2 trial, the study measures the effectiveness of the TAP block in an initial, smaller group, allowing participants to contribute to advancements in pain management.

Will I have to stop taking my current medications?

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

What prior data suggests that the TAP block is safe for bariatric surgery patients?

Research has shown that TAP blocks are generally safe and well-tolerated. One study found that only 11% of patients experienced nausea or vomiting after receiving a TAP block, compared to 45% in the group that received standard care. This finding suggests that TAP blocks might help reduce some common side effects.

Another study found that TAP blocks effectively manage pain immediately after surgery and can reduce the need for morphine, a strong painkiller. This is important for individuals who wish to avoid opioids, which carry side effects and a risk of addiction.

Overall, TAP blocks have been compared to other pain management methods and are considered both safe and effective for reducing pain after abdominal surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transversus Abdominis Plane (TAP) blocks for postoperative pain because they offer a strategic twist on existing pain management methods. Unlike standard practices that deliver TAP blocks at the end of a surgical procedure, delivering them at the beginning may offer more immediate pain relief. This early delivery could potentially reduce the overall need for additional pain medications post-surgery, leading to fewer side effects and a quicker recovery. This approach not only aims to enhance patient comfort but also optimizes pain management right from the start of the surgical process.

What evidence suggests that this trial's TAP block timing could be effective for reducing postoperative pain in bariatric surgery?

Research has shown that the Transversus Abdominis Plane (TAP) block effectively reduces post-surgery pain. Studies have found that it significantly decreases the need for painkillers like opioids. In this trial, participants will receive TAP blocks at different times: some will receive an Early TAP block at the beginning of the procedure, while others will receive a Late TAP block at the end. In patients who underwent abdominal surgeries, TAP blocks reduced both pain and opioid use in the first 24 hours post-surgery. This evidence suggests that TAP blocks can help manage pain and lessen the need for opioids after bariatric surgery. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are having their first bariatric surgery, either Sleeve Gastrectomy or Roux-en-Y Gastric Bypass, at St. Joseph's Healthcare Hamilton. It aims to help with post-surgery pain and reduce opioid use.

Inclusion Criteria

I am having my first weight loss surgery at St. Joseph's, either SG or RYGB.

I am older than 18 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either early or late TAP block during bariatric surgery to assess the optimal timing for pain management

Surgery duration

Immediate Post-operative Recovery

Participants are monitored for opioid consumption, sedation, nausea, vomiting, and respiratory status in the post-anesthetic recovery unit

24 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transversus Abdominis Plane (TAP) Block

Trial Overview The study tests the timing of TAP blocks using Bupivacaine-epinephrine in bariatric surgery. It compares giving the block at the start versus the end of surgery to see which helps recovery and reduces pain and opioid needs better.

How Is the Trial Designed?

Group I: Early TAP block Experimental Treatment 1 Intervention

Patients in this group will receive TAP blocks at the beginning of the procedure

Group II: Late TAP block Active Control 1 Intervention

Patients in this group will receive TAP blocks at the end of their procedure, which is the current standard practice.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

Transversus abdominis plane (TAP) blocks are an effective regional anesthesia technique that can significantly improve postoperative pain management after major abdominal surgeries.

The article provides insights into various TAP block insertion techniques and local anesthetics used, along with recommended nursing care practices to enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transversus abdominis plane blocks: an overview of indication and nursing care. Ladak, SS., Jiang, J., Ojha, M.[2016]

Continuous transversus abdominis plane (TAP) analgesia was effective in providing postoperative pain relief for 124 patients undergoing various abdominal surgeries, with a therapeutic failure rate of only 10%.

The technique showed promising results, with 39% of patients experiencing no analgesic failure and 57% having fewer than 5 episodes of pain over 48 hours, indicating its potential as a primary analgesic method when the surgical incision is within the block's dermatomal limit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four quadrant transversus abdominis plane block and continuous transversus abdominis plane analgesia: a 3-year prospective audit in 124 patients. Niraj, G., Kelkar, A., Hart, E., et al.[2022]

The laparoscopic transversus abdominis plane (TAP) block significantly reduced the need for opioids in the first 6 hours post-surgery, with only 20% of patients in the TAP group requiring opioids compared to 75% in the control group.

Patients receiving the TAP block reported lower pain levels at 6 and 24 hours after surgery, indicating its effectiveness in managing postoperative pain, although no significant differences were observed at 48 hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of laparoscopic transversus abdominis plane block on postoperative pain management and surgery side effects in laparoscopic bariatric surgeries. Jalali, SM., Bahri, MH., Yazd, SMM., et al.[2022]

The study of 97 children aged 5 to 18 showed that ultrasound-guided transversus abdominis plane (TAP) blocks are safe and effective for managing postoperative pain in lower abdominal surgeries, with pain scores decreasing as the time between the TAP block and surgical incision increased.

However, the effectiveness of TAP blocks on long-term pain relief is limited, and factors such as the child's sex and previous surgical history can influence pain levels and parental satisfaction post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic efficacy of ultrasound-guided bilateral transversus abdominis plane block in children: retrospective analysis of 97 cases. Pampal, HK., Erel, S., Turhan, S., et al.[2023]

In a study of 60 patients undergoing radical cystectomy, dexmedetomidine as an adjuvant to bupivacaine in TAP blocks provided significantly longer postoperative analgesia compared to fentanyl, with the first rescue analgesia occurring at an average of 8.90 hours versus 6.50 hours for fentanyl.

Patients receiving dexmedetomidine also required less total analgesic medication in the first 24 hours post-surgery (0.15 mg) compared to those receiving fentanyl (0.20 mg) and the control group (0.24 mg), indicating better pain management with lower opioid consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative study of dexmedetomidine versus fentanyl as adjuvants to bupivacaine in ultrasound-guided transversus abdominis plane block in patients undergoing radical cystectomy: a prospective randomised study. Kassim, DY., Mahmoud, HE., Fakhry, DM., et al.[2022]

The Transversus abdominis plane (TAP) block significantly reduces postoperative pain scores in patients undergoing lower abdominal surgeries, providing effective analgesia for the first 24 hours after surgery.

Patients receiving the TAP block requested their first rescue analgesic much later (265 minutes) compared to those who did not receive the block (66 minutes), indicating that TAP block not only reduces pain but also decreases the need for additional pain medication post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Transversus Abdominis Plane Block for Postoperative Analgesia in Different Lower Abdominal Surgeries in a Tertiary Care Hospital-Chengalpattu District. Manoharan, MM., Gnanadesikan, U., Elavarasan, K., et al.[2023]

Transversus abdominis plane (TAP) blocks significantly reduce postoperative pain after urological procedures, with mean differences in pain intensity scores showing improvements at rest and during movement compared to placebo.

TAP blocks also lead to a significant reduction in opioid consumption in the first 24 hours post-surgery, decreasing the need for morphine equivalents by an average of 12.25 mg, without affecting the rates of postoperative nausea and vomiting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transversus abdominis plane block in urological procedures: A systematic review and meta-analysis. Zayed, M., Allers, K., Hoffmann, F., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10439687/

Efficacy of Transversus Abdominis Plane Block for ... TAP block holds a considerable part in postoperative analgesia. Highly effective for the first 24 hrs in patients undergoing different lower abdominal ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5968225/

Effect of Transversus Abdominis Plane Block on Postoperative ... TAP block was an effective approach for relief of postoperative pain and reduced postoperative consumption of morphine.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1365182X21017342

Preoperative transversus abdominis plane block ... The goal of this study was to determine whether pre-surgical TAP block would result in decreased intraoperative opiate requirements during ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06853782

NCT06853782 | Comparison of Postoperative Analgesic ... In patients undergoing total abdominal hysterectomy, TAP block significantly reduces opioid consumption during the postoperative period and results in marked ...

5. nature.com nature.com/articles/s41598-020-60687-y

Transversus Abdominis Plane Block Reduced Early ... These results indicated that subcostal TAP block by anesthesiologists of varied level of training reduced postoperative pain immediate after RALP.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28271227/

Clinical safety and effectiveness of transversus abdominis ... TAP block is a safe and effective procedure compared to standard care, placebo and other analgesic techniques.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022480420304030

The Efficacy and Safety of Transversus Abdominis Plane ... Of the patients who received a TAP block, 11% reported nausea or vomiting compared with 45% in the standard group (P < 0.01). There were no reported procedure- ...

8. cureus.com cureus.com/articles/378906-comparative-effectiveness-of-transversus-abdominis-plane-tap-block-and-epidural-analgesia-in-abdominal-surgery-a-meta-analysis-of-randomized-controlled-trials

Comparative Effectiveness of Transversus Abdominis ... This meta-analysis compares the efficacy and safety of TAP block versus TEA across multiple postoperative outcomes in abdominal surgery. A ...

9. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06943456

Comparison of Outcome of Open Appendectomy With and ... This study is being conducted to compare two types of pain management techniques in patients undergoing open appendectomy (surgical removal of the appendix ...