Back to resultsThe Effect of Intraoperative Tramadol on Postoperative Opioid (LSG)
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pethidine
Tramadol with pethidine
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring laparoscopic sleeve gastrectomy, morbid obesity, postoperative pain, tramadol, pethidine
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,
Sites / Locations
- Ayman El Nakeeb
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A received Pethidine alone in the period between January 2021 and December 2021,
Group B got Tramadol with pethidine in the period between January 2022 and December 2022.
Arm Description
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.
Outcomes
Primary Outcome Measures
VAS of pain
the severity of pain
opioid requirement
the need of pethidine
Secondary Outcome Measures
hospital stay
hospital stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05696886
Brief Title
The Effect of Intraoperative Tramadol on Postoperative Opioid
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
laparoscopic sleeve gastrectomy, morbid obesity, postoperative pain, tramadol, pethidine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
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.
Allocation
Non-Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A received Pethidine alone in the period between January 2021 and December 2021,
Arm Type
Active Comparator
Arm Description
received Pethidine alone in the period between January 2021 and December 2021, while
Arm Title
Group B got Tramadol with pethidine in the period between January 2022 and December 2022.
Arm Type
Active Comparator
Arm Description
Group B got Tramadol with pethidine in the period between January 2022 and December 2022.
Intervention Type
Drug
Intervention Name(s)
Pethidine
Other Intervention Name(s)
Group A
Intervention Description
Group A received Pethidine alone in the period between January 2021 and December 2021
Intervention Type
Drug
Intervention Name(s)
Tramadol with pethidine
Other Intervention Name(s)
Group B
Intervention Description
Group B got Tramadol with pethidine in the period between January 2022 and December 2022
Primary Outcome Measure Information:
Title
VAS of pain
Description
the severity of pain
Time Frame
48 hours postoperative
Title
opioid requirement
Description
the need of pethidine
Time Frame
one month
Secondary Outcome Measure Information:
Title
hospital stay
Description
hospital stay
Time Frame
one month
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
16-65
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayman E Nakeeb
Organizational Affiliation
Mansoura University, Gastrointestinal Surgery Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ayman El Nakeeb
City
Mansoura
State/Province
Outside U.S And Canada
ZIP/Postal Code
35111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
the study protocol will be available for another researcher
IPD Sharing Time Frame
available for any researcher at any time
IPD Sharing Access Criteria
elnakeebayman@yahoo.com
IPD Sharing URL
http://www.mans.edu.eg/
Citations:
PubMed Identifier
31286397
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.
Results Reference
result
PubMed Identifier
35422388
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.
Results Reference
result
PubMed Identifier
34323436
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.
Results Reference
result
Links:
URL
http://www.mans.edu.eg/
Description
mansoura university
Learn more about this trial
The Effect of Intraoperative Tramadol on Postoperative Opioid
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