Gene Polymorphisms and Morphine Analgesic Consumption

NCT04621864 | Completed DMC

• 1 other identifier: MRC-01-18-270
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Gene; Polymorphosis

Keywords

Gene; Polymorphisms;morphine;analgesia;laparoscopic

Outcome Measures

Primary Outcomes (1)

• genetic polymorphism of human Opioid receptors

  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.

  Day One (D1)

Secondary Outcomes (1)

• The effect of genetic polymorphisms on pain score and analgesic dosage requirements

  Day One (D1)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: To rule out Gender factor in pain
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamad Medical Corporation: lead
• Qatar University: collaborator

Study Sites (1)

HAMAD Medical Corporation- Al Wakra Hospital

Doha, Select, 82228, Qatar

Location

Related Publications (1)

• Elgendy HM, Ibrahim SM, Bader L, Mohammad RA, Ali ZO, Bejaoui MBA, Hilani M, Ismail H, Elewa HF. Genetic Factors Associated with Morphine Consumption in Women Undergoing Laparoscopic Cholecystectomy: A Prospective Cohort Study. J Pain Res. 2023 Jul 15;16:2407-2417. doi: 10.2147/JPR.S420447. eCollection 2023.

  PMID: 37456358 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Withdraw a 5 ml blood sample just after induction anesthesia. This sample will be stored at the refrigerator at 4 °C till handled to one of our research coordinator at faculty of pharmacy at QU.

Study Officials

• HAMED ELGENDY, MD,PhD

  Consultant Anesthesia - HMC & Associate Prof Anesthesia - Qatar University - Adjunct A-Prof Weill Conel Medicine Qatar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: November 9, 2020
• Study Start: November 20, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 8, 2023

Record last verified: 2021-11

Locations

QA (1)