Laparoscopic Versus Ultrasound Guided Block in Sleeve Gastrectomy

NCT06253208 | Recruiting DMC

• 1 other identifier: istinye
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of pain conditions in the first 24 hours after surgery in terms of two different analgesia methods

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  postoperative pain

  4 month

Study Arms (2)

laparoscopic block

laparoscopic transversus abdominis plane block

Procedure: postoperative pain

ultrasound guided block

ultrasound guided transversus abdominis plane block

Procedure: postoperative pain

Interventions

postoperative pain PROCEDURE

Postoperative analgesia in laparoscopic sleeve gastrectomies: laparoscopic versus ultrasound-guided transversus abdominis plane block

laparoscopic block; ultrasound guided block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

50 patients over the age of 18 who will undergo laparoscopic sleeve gastrectomy will be included in the study.

You may qualify if:

• Patients who can tolerate general anesthesia and pneumoperitoneum.
• Patients who can give informed consent for surgery.
• Patients over 18 years of age
• patients with body mass index (BMI) \> 30 kg/m2
• Patients with American Society of Anesthesiologists (ASA) physical status I and II

You may not qualify if:

• Patients allergic to local anesthetics.
• Patients with serious underlying cardiovascular disease (e.g. congestive heart failure, conduction disorders and ischemic heart disease).
• Patients with chronic kidney disease stage 3 or greater (creatinine clearance less than 60 mL/min).
• Patients who have had previous abdominal surgery, including resection of the esophagus, stomach, liver and pancreas.
• Patients with chronic pain and chronic opioid use
• Patients with ASA class IV
• patients with psychiatric disorders
• pregnant or breastfeeding patients
• patients with a history of seizures

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Istinye University

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Okut G, Turgut E, Kaplan K, Bag YM, Akbas S, Sumer F, Kayaalp C. Does laparoscopic-guided transversus abdominis plane block have an effect on postoperative pain and recovery after sleeve gastrectomy? Eur Rev Med Pharmacol Sci. 2022 Aug;26(15):5406-5412. doi: 10.26355/eurrev_202208_29408.

  PMID: 35993635 RESULT

• Hamid HK, Emile SH, Saber AA, Ruiz-Tovar J, Minas V, Cataldo TE. Laparoscopic-Guided Transversus Abdominis Plane Block for Postoperative Pain Management in Minimally Invasive Surgery: Systematic Review and Meta-Analysis. J Am Coll Surg. 2020 Sep;231(3):376-386.e15. doi: 10.1016/j.jamcollsurg.2020.05.020. Epub 2020 Jun 2.

  PMID: 32502615 RESULT

• Venkatraman R, Saravanan R, Dhas M, Pushparani A. Comparison of laparoscopy-guided with ultrasound-guided subcostal transversus abdominis plane block in laparoscopic cholecystectomy - A prospective, randomised study. Indian J Anaesth. 2020 Dec;64(12):1012-1017. doi: 10.4103/ija.IJA_528_20. Epub 2020 Dec 12.

  PMID: 33542563 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

ilke dolgun

CONTACT

+905555485632; ilkeser2004@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: anesthesia and reanimation

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: January 1, 2024
• Primary Completion: April 24, 2024
• Study Completion: June 24, 2024
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)