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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06156657
Other study ID # TAP block
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 30, 2023
Est. completion date December 15, 2023

Study information

Verified date November 2023
Source Al-Azhar University
Contact Ismail M Ahmed, prof
Phone 00201117310053
Email ismailabdelgawad.623@azhar.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 15, 2023
Est. primary completion date November 30, 2023
Accepts healthy volunteers No
Gender All
Age group 21 Years to 60 Years
Eligibility Inclusion Criteria: - Age 20-60 years - ASA ?-?? - BMI >35 Exclusion Criteria: - Patient refusal. - Allergy to study drugs. - Infection at site of injection.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
subcostal TAP block
Comparison between subcostal TAP block and opioids for postoperative pain after laparscopic sleeve gastrectomy

Locations

Country Name City State
Egypt Al Azhar University Cairo Naser City

Sponsors (1)

Lead Sponsor Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative pain control by using VAS score 9 months
Secondary postoperative 24 hour opioid consumption collecting total doses of opioids consumed in the first 24 hours postoperative in cmparison to the other group 9 months
Secondary postoperative nausea and vomiting recording incidence, frequency and severity 9 months
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