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

Trial Summary

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 data supports the effectiveness of the treatment Transversus Abdominis Plane (TAP) Block for postoperative pain?

Research shows that the Transversus Abdominis Plane (TAP) Block is effective for managing pain after abdominal surgeries, including major and lower abdominal procedures, and is beneficial for both adults and children. ^{1 2 3 4 5}

Is the TAP Block generally safe for humans?

Research on TAP Blocks, used for managing pain after surgery, shows they are generally safe with few side effects reported in both children and adults. ^{1 2 3 4 6}

How is the TAP block treatment different from other treatments for postoperative pain?

The TAP block is a unique treatment for postoperative pain because it involves a regional anesthesia technique that targets nerves in the abdominal wall to reduce pain after surgery. Unlike systemic pain medications, it provides localized pain relief, which can help reduce the need for opioids and their associated side effects. ^{1 2 3 4 7}

What is the purpose of this trial?

This clinical trial aims to determine the optimal timing for administering a Transversus Abdominis Plane (TAP) block in bariatric surgery, specifically investigating whether initiating TAP blocks at the beginning of surgery is more beneficial than at the end, which is the current practice. The study targets obese patients undergoing bariatric surgery, with a focus on reducing postoperative pain and opioid use. Key outcomes include recovery duration, pain levels, opioid consumption, and respiratory function. Successful results could establish early TAP block initiation as a standard practice, offering faster recovery, decreased opioid reliance, and reduced healthcare costs.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

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

Transversus abdominis plane blocks: an overview of indication and nursing care. [2016]

2. England 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. [2022]

3. Netherlands 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. [2023]

4. Turkey pubmed.ncbi.nlm.nih.gov

Analgesic efficacy of ultrasound-guided bilateral transversus abdominis plane block in children: retrospective analysis of 97 cases. [2023]

5. United States 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. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of laparoscopic transversus abdominis plane block on postoperative pain management and surgery side effects in laparoscopic bariatric surgeries. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Transversus abdominis plane block in urological procedures: A systematic review and meta-analysis. [2023]