The Impact of CYP2D6 Polymorphism on Tramadol Pharmacodynamics

NCT06814652 | Active Not Recruiting DMC

• 1 other identifier: ElweyiaMTH
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

CYP2D6 is an enzyme involved in the hepatic metabolism of many clinically important drugs: antiarrhythmics, antidepressants, antipsychotics, β-blockers, and analgesics such as tramadol and codeine. CYP2D6 is highly polymorphic and significant interindividual variability has been observed worldwide. This study aims to investigate the distribution of CYP2D6 polymorphisms among post-cesarean female patients in Erbil city, Iraq. The findings of this study may indicate the presence of CYP2D6 gene variants among the Kurdish female population in Erbil, which could contribute to tramadol analgesic failure or exaggerated adverse effects. This study could also serve as a foundation for further pharmacogenetic research, individualizing treatments and targeting a larger sample size in the future.

Conditions

Post-cesarean Pain; CYP2D6 Polymorphism; Tramadol Resistance

Outcome Measures

Primary Outcomes (1)

• Visual analog scale (10 cm)

  Visual analog scale is used for measuring pain intensity on a scale of 0 to 10, in which a score on the line is marked by each patient ranging from "no pain" to "worst pain". The pain intensity increases as the score on the scale goes up.

  after 1 hour and 6 hours of receiving single dose of tramadol

Secondary Outcomes (6)

• Blood pressure (mm of Hg)

  after 1 hour and 6 hours of receiving single dose of tramadol

• Heart rate (beats per minute)

  after 1 hour and 6 hours of receiving single dose of tramadol

• Oxygen saturation (SPO2%)

  after 1 hour and 6 hours of receiving single dose of tramadol

• Nocturnal pain

  after 24 hours of receiving single dose of tramadol

• Dietary state

  after 24 hours of receiving single dose of tramadol

Study Arms (1)

post-cesarean patients

All of these patients were planned to undergo elective cesarean surgery and receive postpartum management for twenty-four hours at the Erbil Maternity and Childbirth Hospital. Consent was taken from each patient prior to the enrollment into the study. Their age ranged between 21-42 years. Patients received one dose of tramadol drug (100mg/2ml of Trodon® Hemofarm) intravenously for management of postpartum pain after gaining back their pain sensation.

Drug: Trodon® Hemofarm

Interventions

Trodon® Hemofarm DRUG

Consent was taken from each patient prior to the enrollment into the study during the first interview and 2 ml of blood was withdrawal for the CYP2D6 genotyping. After the cesarean section surgery, each patient received one dose of 100mg/2ml Trodon® Hemofarm for treating the postpartum pain and the patients were monitored for 24 hours. Follow-up was performed for each enrolled patient in which the VAS score, blood pressure, heart rate, oxygen saturation and any new effects after 1 hour, 6 hours of tramadol administration were recorded. In addition, after 24 hours evaluations for nocturnal pain, dietary state and bowel movement were performed.

post-cesarean patients

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: female patients who were pregnant and indicated for elective cesarean section surgery for the delivery of singleton baby.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients who were indicated for elective cesarean section surgery at public hospital (Maternity Teaching hospital) located in Erbil city, Iraq were enrolled.

You may qualify if:

• Female patients aged between 18-56 years old
• Patients who undergo cesarean section surgery
• Patients receive tramadol drug for postpartum pain management

You may not qualify if:

• Patients with any history of severe renal, liver, respiratory diseases and/or seizures
• Patients with history of psychiatric disorders or unable to provide consent
• Patients with complicated surgeries or neonatal distress or unable to perform the clinical assessment of pain
• Patients with history of consumption of chronic alcohol or opioid or drug abuse
• Patients with history of known allergy to tramadol

Sponsors & Collaborators

• Elweyia Maternity Teaching Hospital: lead

Study Sites (1)

Hawler Medical University/ College of Medicine

Erbil, 40/0112, Iraq

Location

Biospecimen

Retention: SAMPLES WITH DNA

2 ml of whole blood was collected in EDTA tube

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Investigator

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 7, 2025
• Study Start: September 22, 2024
• Primary Completion: December 20, 2024
• Study Completion: March 31, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

IR (1)