The Effect of Intraoperative Tramadol on Postoperative Opioid

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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 Groups

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

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

Group Type ACTIVE_COMPARATOR

Pethidine

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Tramadol with pethidine

Intervention Type DRUG

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

Interventions

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Pethidine

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

Intervention Type DRUG

Tramadol with pethidine

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

Intervention Type DRUG

Other Intervention Names

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Group A Group B

Eligibility Criteria

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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