Genetics of Cytochrome CYP2D6 and Effects of Codeine and Tramadol on Postoperative Pain Management

NCT06723379 | Completed

• 1 other identifier: 21-01422
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Codeine is one of the most commonly prescribed opioids in the world. The speed at which our liver metabolizes codeine into morphine depends on an important protein called cytochrome P450 2D6 (CYP2D6). Many people across the world have different CYP2D6 metabolizing speeds. Codeine provides inadequate pain management to those who have slow-metabolizing CYP2D6. In contrast, codeine can be life-threatening to those who have rapidly-metabolizing CYP2D6 because of the abruptly high dose of morphine. By analyzing specific genes, we are able to predict a patient's response to medication, thus drug type and dosing can be tailored according to their genetics. The purpose of this study is to observe if nanopore CYP2D6 DNA genetic sequencing can classify patients according to their CYP2D6 phenotype and thus predict their response to codeine and tramadol. The overall project is to determine the practicality of a genetic survey of CYP2D6 for healthy patients undergoing surgical procedures.

Conditions

Post-operative Pain

Outcome Measures

Primary Outcomes (1)

• CYP2D6 genotypes/phenotypes

  CYP2D6 genotype determined by nanopore DNA sequencing which will be cross-referenced with published genotypes to determine CYP2D6 phenotype

  6 months

Secondary Outcomes (7)

• Total opiate consumption

  6 months

• Pain scores

  6 months

• Sedation level

  6 months

• Administration of anti-nausea medications

  6 months

• Postoperative Day 1 current pain and worst pain since discharge

  6 months

Study Arms (1)

Healthy surgical patients

Healthy surgical patients who are undergoing surgical procedures with projected moderate postoperative pain.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

For the pilot study, healthy patients (ASA 1 or 2) who are undergoing surgical procedures at Royal Columbian Hospital or Eagle Ridge Hospital with projected moderate postoperative pain will be selected. It is estimated that five patients will be approached to learn more about the study each week and 50-60% will consent to participate given the minimally invasive study procedures and the potential for participants to learn valuable personal pain medication metabolizing genetic status. Therefore, this study aims to enroll approximately ten patients per month up to a maximum of fifty total patients over a five-month span.

You may qualify if:

• Age 18-55 year and otherwise healthy (ASA 1 or 2)
• Undergoing an elective outpatient surgical procedure at Royal Columbian Hospital or Eagle Ridge Hospital with projected moderate post-operative pain
• Surgical procedure that requires general anaesthetic and post-operative pain management routinely managed with either codeine or tramadol by attending surgeon (i.e., ACL repair)
• Attending surgeon routinely prescribes either tramadol or codeine for post-operative pain management

You may not qualify if:

• Pre-existing chronic pain condition
• Any psychiatric diagnosis, such as depression or anxiety (Lautenbacher et al., 1994)
• History of substance abuse/dependence
• Multiple medical comorbidities (a single well-controlled medical comorbidity will not be a contraindication - i.e., controlled hypothyroidism)
• Allergy, sensitivity, or other contraindication to either codeine or tramadol
• Regional anesthetic (inclusive either of a major peripheral nerve block or neuraxial anesthetic) planned by attending anesthesiologist)
• Unable to provide informed consent

Sponsors & Collaborators

• Fraser Health: lead
• University of British Columbia: collaborator

Study Sites (1)

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

A single EDTA tube of 2-3 mL of blood will be collected in the OR as per standard procedure and the tube will be labelled in the standard way with a computer generated label containing the standard patient identifiers.

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Perseus Missirlis, MSc, MD

  Fraser Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: November 25, 2022
• Primary Completion: July 10, 2024
• Study Completion: December 1, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)