The Effect of Intraoperative Tramadol on Postoperative Opioid

Postoperative Pain Clinical Trial

— LSG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05696886
• Other study ID #: R.23.01.2008
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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,

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Pethidine
Group A received Pethidine alone in the period between January 2021 and December 2021
• Tramadol with pethidine
Group B got Tramadol with pethidine in the period between January 2022 and December 2022

Locations

Country	Name	City	State
Egypt	Ayman El Nakeeb	Mansoura	Outside U.S And Canada

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Tian C, Lee Y, Oparin Y, Hong D, Shanthanna H. Benefits of Transversus Abdominis Plane Block on Postoperative Analgesia after Bariatric Surgery: A Systematic Review and Meta-Analysis. Pain Physician. 2021 Aug;24(5):345-358. — View Citation

Zeeni C, Aouad MT, Daou D, Naji S, Jabbour-Khoury S, Alami RS, Safadi BY, Siddik-Sayyid SM. The Effect of Intraoperative Dexmedetomidine Versus Morphine on Postoperative Morphine Requirements After Laparoscopic Bariatric Surgery. Obes Surg. 2019 Dec;29(12 — View Citation

Zhang Y, Zhou Y, Hu T, Tong X, He Y, Li X, Huang L, Fu Q. Dexmedetomidine reduces postoperative pain and speeds recovery after bariatric surgery: a meta-analysis of randomized controlled trials. Surg Obes Relat Dis. 2022 Jun;18(6):846-853. doi: 10.1016/j. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS of pain	the severity of pain	48 hours postoperative
Primary	opioid requirement	the need of pethidine	one month
Secondary	hospital stay	hospital stay	one month

External Links

•   mansoura university