The Effect of Intraoperative Tramadol on Postoperative Opioid

NCT05696886 | Completed DMC

• 1 other identifier: R.23.01.2008
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Pain

Keywords

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

Outcome Measures

Primary Outcomes (2)

• VAS of pain

  the severity of pain

  48 hours postoperative

• opioid requirement

  the need of pethidine

  one month

Secondary Outcomes (1)

• hospital stay

  one month

Study Arms (2)

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

ACTIVE COMPARATOR

received Pethidine alone in the period between January 2021 and December 2021, while

Drug: Pethidine

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

ACTIVE COMPARATOR

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

Drug: Tramadol with pethidine

Interventions

Pethidine DRUG

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

Also known as: Group A

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

Tramadol with pethidine DRUG

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

Also known as: Group B

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

Eligibility Criteria

• Age: 16 Years - 65 Years
• Gender Eligibility Details: 16-65
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients under the age of 16 or over 65,
• Those with severe GERD, leakage
• pregnancy, or
• inflammatory bowel disease,

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Ayman El Nakeeb

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

Location

Related Publications (3)

• 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.

  PMID: 31286397 RESULT

• 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.

  PMID: 35422388 RESULT

• 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.

  PMID: 34323436 RESULT

Related Links

• mansoura university

MeSH Terms

Conditions

Pain, Postoperative; Obesity, Morbid

Interventions

Meperidine; Tramadol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Isonipecotic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Ayman E Nakeeb

  Mansoura University, Gastrointestinal Surgery Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Gastroenterology surgical center, mansoura university

Model Details: 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.

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 25, 2023
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: available for any researcher at any time
• Access Criteria: elnakeebayman@yahoo.com

Locations

EG (1)