The Effect of Intraoperative Tramadol on Postoperative Opioid

Study Overview
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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

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.

Official Title
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The Effect of Intraoperative Tramadol on Postoperative Opioid Requirements After Laparoscopic Sleeve Gastrectomy for Morbid Obese Patients (A Retrospective Multicentric Cohort Study)

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Pethidine
* Drug: Tramadol with pethidine


Participation Criteria
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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 Exclusion Criteria: Patients under the age of 16 or over 65, Those with severe GERD, leakage pregnancy, or inflammatory bowel disease,

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A received Pethidine alone in the period between January 2021 and December 2021,<br>received Pethidine alone in the period between January 2021 and December 2021, while | Drug: Pethidine<br>* Group A received Pethidine alone in the period between January 2021 and December 2021<br>* Other names: Group A;|
| Active Comparator: Group B got Tramadol with pethidine in the period between January 2022 and December 2022.<br>Group B got Tramadol with pethidine in the period between January 2022 and December 2022. | Drug: Tramadol with pethidine<br>* Group B got Tramadol with pethidine in the period between January 2022 and December 2022<br>* Other names: Group B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS of pain | the severity of pain | 48 hours postoperative | 
| opioid requirement | the need of pethidine | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital stay | hospital stay | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic sleeve gastrectomy, morbid obesity, postoperative pain, tramadol, pethidine