Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06814652

The Impact of CYP2D6 Polymorphism on Tramadol Pharmacodynamics

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Post-cesarean Pain CYP2D6 Polymorphism Tramadol Resistance

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Hawler Medical University/ College of Medicine

Erbil, 40/0112, Iraq

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Visual analog scale (10 cm)

    Time frame: after 1 hour and 6 hours of receiving single dose of tramadol

    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.

Secondary outcomes

  1. Blood pressure (mm of Hg)

    Time frame: after 1 hour and 6 hours of receiving single dose of tramadol

    Blood pressure was measured by automatic blood pressure monitor (mm of Hg) after 1 hour and 6 hours of IV tramadol administration to detect any change in the blood pressure of each patient.

  2. Heart rate (beats per minute)

    Time frame: after 1 hour and 6 hours of receiving single dose of tramadol

    Pulse was recorded by pulse oximetry (beats per minute) after 1 hour and 6 hours of IV tramadol administration to detect any change in the heart rate of each patient.

  3. Oxygen saturation (SPO2%)

    Time frame: after 1 hour and 6 hours of receiving single dose of tramadol

    Oximetry was used (SPO2 %) for evaluating the oxygen saturation of each patient.

  4. Nocturnal pain

    Time frame: after 24 hours of receiving single dose of tramadol

    Evaluation of nocturnal pain was performed for each patient by a questionnaire after 24 hours to determine pain at night and whether it has impacted on the sleeping quality of the patient.

  5. Dietary state

    Time frame: after 24 hours of receiving single dose of tramadol

    Evaluation of dietary state was performed for each patient, in which the patient was asked after 24 hours to determine whether they have taken anything within the last 24 hours and if yes did they take liquid and/or solid food.

  6. Adverse effects

    Time frame: after 1 hour and 6 hours of receiving single dose of tramadol for recording any adverse effects, and after 24 hours of receiving single dose of tramadol for evaluation of the bowel movement (whether the patient was constipated).

    A questionnaire was presented to each patient for recording any newly appearing effects that are noticed by the patient after 1 hour and 6 hours of receiving single dose of tramadol drug intravenously. In addition, the patient was asked after 24 hours whether they had had bowel movement within the last 24 hours (whether the patient was constipated).

Sponsors and collaborators

Lead sponsor

Elweyia Maternity Teaching Hospital

Other

Registry information

Official study title

The Outcome of CYP2D6 Polymorphism on Tramadol Analgesia in Postpartum Patients in Erbil

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 7, 2025
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.