Gene Polymorphisms and Morphine Analgesic Consumption

Sponsor

Hamad Medical Corporation (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04621864

Collaborator

Qatar University (Other)

300

Enrollment

Location

38.4

Anticipated Duration (Months)

7.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Variation of morphine requirements are seen considerably. Studies showed that pharmacogenetics (PGx) could possibly be used to tailor pain medication according to an individual's genetic background. While prior studies demonstrated the association of genetic polymorphism with opioid requirements in various types of surgeries in Asian and European populations, there are no published data in Middle East populations especially Arabs. However, in our area we have a lot of theincity that may give us an answer for this research question.

Objectives: The primary Objective of this study is to investigate whether the genetic polymorphism of human μ-opioid receptor gene (OPRM1), ATP binding cassette gene (ABCB1) and rs2952768 are contributing to the variation of morphine consumption in women undergoing laparoscopic cholecystectomy. The secondary objective is to assess the effect of these genetic polymorphisms on pain score, analgesic dosage requirements, and complications of morphine use in these patients within the first 24 hours.

Condition or Disease	Intervention/Treatment	Phase
Gene Polymorphosis

Detailed Description

Background: Variation of morphine requirements are seen considerably. Studies showed that pharmacogenetics (PGx) could possibly be used to tailor pain medication according to an individual's genetic background. While prior studies demonstrated the association of genetic polymorphism with opioid requirements in various types of surgeries in Asian and European populations, there are no published data in Middle East populations especially Arabs.

Methods: This is a pilot prospective cohort study to be conducted at Al-Wakrah Hospital, HMC after receiving IRB approval from MRC. The aim is to recruit 100 adult female Arab patients with American Society of Anesthesiologists physical status of I or II in whom planned postoperative pain management by morphine will be requested after laparoscopic cholecyctectomy Baseline demographic information will be collected at baseline along with 4ml blood sample for genotyping. Morphine will be administered repeatedly for postoperative pain relief and the total dose administered within the first 24 hours will be collected. The analgesic effect will be evaluated using a visual analogue scale (VAS). Multiple linear regression will be used to evaluate the association of the genetic variant groups with the morphine dose and the pain score after adjusting for different confounders. Logistic regression will be used to evaluate the association of side effect of vomiting and respiratory depression with the genetic variants. Baseline characteristic values will be reported as mean ± SD for continuous variables or frequency and percentage for categorical variables. A priori P value of ≤ 0.05 will be considered significant. All analyses will be done using the Statistical version 25 of SPSS software.

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Can Gene Polymorphisms Influence Morphine Analgesic Consumption After Laparoscopic Cholecystectomy? A Prospective Cohort Study.

Actual Study Start Date :

Oct 20, 2019

Anticipated Primary Completion Date :

Mar 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Outcome Measures

Primary Outcome Measures

genetic polymorphism of human Opioid receptors [Day One (D1)]
The primary Objective of this study is to investigate whether the genetic polymorphism of human μ-opioid receptor gene (OPRM1), ATP binding cassette gene (ABCB1) and rs2952768 are contributing to the variation of morphine consumption in women undergoing laparoscopic cholecystectomy.

Secondary Outcome Measures

The effect of genetic polymorphisms on pain score and analgesic dosage requirements [Day One (D1)]
The secondary objective is to assess the effect of these genetic polymorphisms on pain score, analgesic dosage requirements, and complications of morphine use in these patients within the first 24 hours.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

. They agree to participate and sign the informed consent
They are older than 18 years
They are women undergoing laparoscopic cholecystectomy.

Exclusion Criteria:

. They have significant respiratory, cardiovascular, renal, hepatic diseases or diabetes.
They have history of allergy to morphine and those with bad experience to morphine side effects.
They have chronic pain and those taking pain medications.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HAMAD Medical Corporation- Al Wakra Hospital	Doha	Select	Qatar	82228

Sponsors and Collaborators

Hamad Medical Corporation
Qatar University

Investigators

Principal Investigator: HAMED ELGENDY, MD,PhD, Consultant Anesthesia - HMC & Associate Prof Anesthesia - Qatar University - Adjunct A-Prof Weill Conel Medicine Qatar

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hamad Medical Corporation

ClinicalTrials.gov Identifier:

NCT04621864

Other Study ID Numbers:

MRC-01-18-270

First Posted:

Nov 9, 2020

Last Update Posted:

Aug 5, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hamad Medical Corporation

Gene; Polymorphisms;morphine;analgesia;laparoscopic

Study Results

No Results Posted as of Aug 5, 2021