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The Effect of Intraoperative Tramadol on Postoperative Opioid

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05696886
Acronym
LSG
Enrollment
400
Registered
2023-01-25
Start date
2021-01-01
Completion date
2022-12-31
Last updated
2023-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

laparoscopic sleeve gastrectomy, morbid obesity, postoperative pain, tramadol, pethidine

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.

Interventions

DRUGPethidine

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

DRUGTramadol with pethidine

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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking 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.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No

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,

Design outcomes

Primary

MeasureTime frameDescription
VAS of pain48 hours postoperativethe severity of pain
opioid requirementone monththe need of pethidine

Secondary

MeasureTime frameDescription
hospital stayone monthhospital stay

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026