Clinical trial NCT05696886: The Effect of Intraoperative Tramadol on Postoperative Opioid
Official title: The Effect of Intraoperative Tramadol on Postoperative Opioid Requirements After Laparoscopic Sleeve Gastrectomy for Morbid Obese Patients (A Retrospective Multicentric Cohort Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: laparoscopic sleeve gastrectomy
morbid obesity
postoperative pain
tramadol
pethidine
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 400
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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,

Primary outcomes:
measure: VAS of pain
timeFrame: 48 hours postoperative
measure: opioid requirement
timeFrame: one month
Secondary outcomes:
measure: hospital stay
timeFrame: one month
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Ayman El Nakeeb
state: Outside U.S And Canada
Study officials:
affiliation: Mansoura University, Gastrointestinal Surgery Center
name: Ayman E Nakeeb
role: PRINCIPAL_INVESTIGATOR
References:
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):3800-3808. doi: 10.1007/s11695-019-04074-1.
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.soard.2022.03.002. Epub 2022 Mar 9.
citation: 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.