Clinical trial NCT06156657: Postoperative Analgesia of TAP Block for Laparoscopic Sleeve Gastrectomy
Official title: Postoperative Efficacy of Subcostal TAP Block in Laparoscopic Sleeve Gastrectomy Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain
Keywords: subcostal TAP
laparoscopic
sleeve gastrectomy
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: many methods were considered to control postoperative pain in laparoscopic bariatic surgery including non steroidal anti-inflammatory drugs, opioids and neuraxial block

but subcostal (TAP) block has provided good analgesic effect when used as a part of multimodal analgesia in bariatric surgery due to lack of visceral block

Detailed description: Since long time opioid have been used to control postoperative pain in bariatric surgery However, an increasing awareness of opioid-related adverse events, including respiratory depression, paralytic ileums, and sedation, constipation has led to a shift towards utilizing opioid-sparing techniques for postoperative analgesia As neuroaxial block and ultrasound guided nerve blocks

As the transverse abdominis plane (TAP) block which is of increasing interest nowadays (Basaran B, et al 2015)

The ultrasound-guided oblique SCTAP block, first described by Hebbard et al., has the potential to provide analgesia for both upper and lower abdominal surgery. There is a growing consensus that the SCTAP block provides better analgesia for upper abdominal incisions

The TAP block via various approaches provides some advantages over neuraxial anesthesia (Ganapathy Set al 2015). For example, TAP blocks are associated with a lower use of intraoperative phenylephrine and a lesser degree of intraoperative blood pressure changes. The SCTAP block may be utilized in cases in which neuraxial anesthesia is contraindicated, such as patients with coagulation issues or infection at the epidural puncture site. Although the SCTAP block provides sensory blockade of the abdominal wall, it is lacking in coverage of visceral pain (Lissauer J,et al 2014).

The lack of visceral pain analgesia may require the use of additional methods of postoperative pain control such as intravenous opioids or non-narcotic analgesics.

Eligibility criteria: Inclusion Criteria:

* Age 20-60 years
* ASA Ι-ΙΙ
* BMI \>35

Exclusion Criteria:

* Patient refusal.
* Allergy to study drugs.
* Infection at site of injection.

Primary outcomes:
measure: Postoperative pain control
timeFrame: 9 months
Secondary outcomes:
measure: postoperative 24 hour opioid consumption
timeFrame: 9 months
measure: postoperative nausea and vomiting
timeFrame: 9 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al Azhar University
state: Naser City
Study officials:
References:
citation: Basaran B, Basaran A, Kozanhan B, Kasdogan E, Eryilmaz MA, Ozmen S. Analgesia and respiratory function after laparoscopic cholecystectomy in patients receiving ultrasound-guided bilateral oblique subcostal transversus abdominis plane block: a randomized double-blind study. Med Sci Monit. 2015 May 7;21:1304-12. doi: 10.12659/MSM.893593.
citation: Hebbard PD, Barrington MJ, Vasey C. Ultrasound-guided continuous oblique subcostal transversus abdominis plane blockade: description of anatomy and clinical technique. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):436-41. doi: 10.1097/aap.0b013e3181e66702.
citation: Ganapathy S, Sondekoppam RV, Terlecki M, Brookes J, Das Adhikary S, Subramanian L. Comparison of efficacy and safety of lateral-to-medial continuous transversus abdominis plane block with thoracic epidural analgesia in patients undergoing abdominal surgery: A randomised, open-label feasibility study. Eur J Anaesthesiol. 2015 Nov;32(11):797-804. doi: 10.1097/EJA.0000000000000345.
citation: Lissauer J, Mancuso K, Merritt C, Prabhakar A, Kaye AD, Urman RD. Evolution of the transversus abdominis plane block and its role in postoperative analgesia. Best Pract Res Clin Anaesthesiol. 2014 Jun;28(2):117-26. doi: 10.1016/j.bpa.2014.04.001. Epub 2014 May 9.