Post-cesarean PainNCT06814652
The Impact of CYP2D6 Polymorphism on Tramadol Pharmacodynamics
An observational study of Post-cesarean Pain and CYP2D6 Polymorphism, run by Elweyia Maternity Teaching Hospital at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Post-cesarean Pain, CYP2D6 Polymorphism, Tramadol Resistance
- What is being tested?
- Trodon® Hemofarm
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteIraq
- Study dates
- 22 Sep 2024to 30 Apr 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Outcome of CYP2D6 Polymorphism on Tramadol Analgesia in Postpartum Patients in Erbil
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
- Being tested
- Trodon® Hemofarm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trodon® HemofarmDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Trodon® Hemofarm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 1 hour and 6 hours of receiving single dose of tramadol
Secondary outcomes (6)
Blood pressure (mm of Hg)
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.
Measured: after 1 hour and 6 hours of receiving single dose of tramadol
Heart rate (beats per minute)
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.
Measured: after 1 hour and 6 hours of receiving single dose of tramadol
Oxygen saturation (SPO2%)
Oximetry was used (SPO2 %) for evaluating the oxygen saturation of each patient.
Measured: after 1 hour and 6 hours of receiving single dose of tramadol
Nocturnal pain
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.
Measured: after 24 hours of receiving single dose of tramadol
Dietary state
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.
Measured: after 24 hours of receiving single dose of tramadol
Adverse effects
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).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start22 Sep 2024
- Primary completion23 Feb 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-cesarean PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Elweyia Maternity Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaymaa Faruq Hamadameen, Elweyia Maternity Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814652
- Sponsor's protocol ID
- ElweyiaMTH
- Status last verified
- Aug 2026
- First submitted
- 28 Jan 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
https://doi.org/10.3897/pharmacia.72.e162100
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcome of CYP2D6 Polymorphism on Tramadol Analgesia in Postpartum Patients in Erbil
- ClinicalTrials.gov ID
- NCT06814652
- Acronym / sponsor ID
- ElweyiaMTH
- Conditions
- Post-cesarean Pain, CYP2D6 Polymorphism, Tramadol Resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Elweyia Maternity Teaching HospitalUniversity, hospital or other
- Study start
- 22 Sep 2024 (actual)
- Primary completion
- 23 Feb 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| post-cesarean patients | – | Drug: Trodon® HemofarmAll 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trodon® HemofarmConsent 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. | Drug | post-cesarean patients |
Primary outcome
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.
6 secondary outcomes
Blood pressure (mm of Hg)
Time frame: after 1 hour and 6 hours of receiving single dose of tramadol
Heart rate (beats per minute)
Time frame: after 1 hour and 6 hours of receiving single dose of tramadol
Oxygen saturation (SPO2%)
Time frame: after 1 hour and 6 hours of receiving single dose of tramadol
Nocturnal pain
Time frame: after 24 hours of receiving single dose of tramadol
Dietary state
Time frame: after 24 hours of receiving single dose of tramadol
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Results publicationhttps://doi.org/10.3897/pharmacia.72.e162100
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-cesarean Pain and CYP2D6 Polymorphism, run by Elweyia Maternity Teaching Hospital at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (10 cm) (time frame: after 1 hour and 6 hours of receiving single dose of tramadol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06814652, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.