The Effect of Intraoperative Tramadol on Postoperative Opioid (LSG)

Mansoura University

Status: Completed

Conditions: Postoperative Pain

Treatments: Drug: Tramadol with pethidine; Drug: Pethidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05696886

R.23.01.2008

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Group A received Pethidine alone in the period between January 2021 and December 2021,

Active Comparator group

Description:

received Pethidine alone in the period between January 2021 and December 2021, while

Treatment:

Drug: Pethidine

Group B got Tramadol with pethidine in the period between January 2022 and December 2022.

Active Comparator group

Description:

Group B got Tramadol with pethidine in the period between January 2022 and December 2022.

Treatment:

Drug: Tramadol with pethidine