CYP2D6 Polymorphism, Post-cesarean Pain, Tramadol Resistance
Conditions
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.
Interventions
DRUGTrodon® Hemofarm
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.
Sponsors
Elweyia Maternity Teaching Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Female patients aged between 18-50 years old * Patients who are indicated to undergo elective cesarean section surgery * Patients that are indicated to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog scale (10 cm) | 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
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure (mm of Hg) | 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. |
| Dietary state | 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. |
| Oxygen saturation (SPO2%) | after 1 hour and 6 hours of receiving single dose of tramadol | Oximetry was used (SPO2 %) for evaluating the oxygen saturation of each patient. |
| Nocturnal pain | 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. |
| Adverse effects | 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). |
| Heart rate (beats per minute) | 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. |
Countries
Iraq
Outcome results
None listed