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OpenTrials
Completed

NCT Number: NCT05696886

The Effect of Intraoperative Tramadol on Postoperative Opioid

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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Key information

Conditions

Postoperative Pain Body Weight Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ayman El Nakeeb

Al Mansurah, Outside U.S and Canada, 35111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Pethidine

Drug

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

Other names: Group A

Tramadol with pethidine

Drug

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

Other names: Group B

Primary outcomes

  1. VAS of pain

    Time frame: 48 hours postoperative

    the severity of pain

  2. opioid requirement

    Time frame: one month

    the need of pethidine

Secondary outcomes

  1. hospital stay

    Time frame: one month

    hospital stay

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Acronym: LSG

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 25, 2023
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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