The Effect of Intraoperative Tramadol on Postoperative Opioid

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Pethidine; Drug: Tramadol with pethidine

• Registration Number: NCT05696886
• Lead Sponsor: Mansoura University

Brief Summary

Postoperative pain remains a very UNPLEASENTevent, particularly in morbidly obese patients that may be associated with obstructive sleep apnea. Bariatric surgery patients must get safe and efficient analgesia, which is essential given that up to 45 % of patients report substantial pain in the first two days following surgery. The study's purpose was to compare the efficacy and safety of combined tramadol with pethidine versus pethidine alone and to assess their impact on postoperative pethidine requirements after LSG for morbidly obese patients

Detailed Description

This multicenter cohort research included patients with morbid obesity who had LSG between January 2021 and December 2022. The patients included in the study were allocated to one of two treatment groups that were not randomized but the patients were categorized according to the time of surgery: Group A received Pethidine alone in the period between January 2021 and December 2021, while Group B got Tramadol with pethidine in the period between January 2022 and December 2022. Doses were based on the patient's actual body weight.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-01
• Study First Submitted: 2023-01-13
• Study First Submitted QC: 2023-01-23
• Last Update Submitted: 2023-01-23
• Study First Posted: 2023-01-25
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patients with morbid obesity defined as a BMI of more than 40 or
• BMI less than 35 with at least one comorbidity and
• ages ranging from 16 to 65, were patients

Exclusion Criteria

• Patients under the age of 16 or over 65,
• Those with severe GERD, leakage
• pregnancy, or
• inflammatory bowel disease,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A received Pethidine alone in the period between January 2021 and December 2021,	Pethidine	received Pethidine alone in the period between January 2021 and December 2021, while
Group B got Tramadol with pethidine in the period between January 2022 and December 2022.	Tramadol with pethidine	Group B got Tramadol with pethidine in the period between January 2022 and December 2022.

Primary Outcome Measures

Name	Time	Method
VAS of pain	48 hours postoperative	the severity of pain
opioid requirement	one month	the need of pethidine

Secondary Outcome Measures

Name	Time	Method
hospital stay	one month	hospital stay

Trial Locations

Locations (1)

Ayman El Nakeeb; 🇪🇬 Mansoura, Outside U.S And Canada, Egypt