Clinical trial NCT04621864: Gene Polymorphisms and Morphine Analgesic Consumption
Official title: Can Gene Polymorphisms Influence Morphine Analgesic Consumption After Laparoscopic Cholecystectomy? A Prospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gene
Polymorphosis
Keywords: Gene; Polymorphisms;morphine;analgesia;laparoscopic
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
Collaborators: name: Qatar University
First posted: 2020-11-09
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: After the approval of the our institutional review board committee IRB at HAMAD MEDICAL CORPORATION (HMC), Doha, Qatar, and written, informed consent, 100 adult female 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 cholecystectomy can will be included in this study; at the Wakrah Hospital, HMC. We planned to study 300 patients. If a genetic abnormality was found in 15% of patients and the average total morphine use in this subgroup was 40% lower than in the remainder of the patients, then there was 80% chance that a t test comparing average log-total morphine would be significant at P ≤ 0.05.

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.

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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: genetic polymorphism of human Opioid receptors
timeFrame: Day One (D1)
Secondary outcomes:
measure: The effect of genetic polymorphisms on pain score and analgesic dosage requirements
timeFrame: Day One (D1)
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: HAMAD Medical Corporation- Al Wakra Hospital
state: Select
Study officials:
affiliation: Consultant Anesthesia - HMC & Associate Prof Anesthesia - Qatar University - Adjunct A-Prof Weill Conel Medicine Qatar
name: HAMED ELGENDY, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: