Post Operative AnalgesiaTramadolNCT06642480
Distribution of CYP2D6 Multiplication, CYP2D6*5, and Clinical Implications in Postoperative Patients Receiving Tramadol Analgesia in the Minangkabau Ethnic Group, Indonesia
A study testing Post Operative Analgesia in people with Post Operative Analgesia and Tramadol, run by Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia at 1 site in Indonesia.
Trial summary
Cytochrome P450 2D6 (CYP2D6) is an important enzyme in metabolizing commonly used drugs such as Tramadol hydrochloride (widely used opioid analgesic). Genetic polymorphisms of the CYP2D6 gene have been shown to influence the pharmacodynamic properties of the administered drug. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Post Operative Analgesia, Tramadol
- What is being tested?
- Post Operative Analgesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2022to 1 Mar 2023
- Phase
- Interventional
- 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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Post operative patients who get analgesic tramadol
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Patients' Visual Analogue Scale (VAS) in Postoperative Patients Receiving Tramadol Analgesia in the Minangkabau Ethnic Group, Indonesia
Cytochrome P450 2D6 (CYP2D6) is an important enzyme in metabolizing commonly used drugs such as Tramadol hydrochloride (widely used opioid analgesic). Genetic polymorphisms of the CYP2D6 gene have been shown to influence the pharmacodynamic properties of the administered drug. This study aimed to screen 63 postoperative patients (wild-type, CYP2D6*5, and CYP2D6 multiplication) of Minangkabau ethnicity in West Sumatera, Indonesia, who received tramadol using a modified long PCR method and to investigate the clinical impact of tramadol on the patients.
Read the detailed description
VAS of 63 patients was determined by injecting tramadol at a dose of 100 mg 30 minutes before the operation was completed. It was observed in the recovery room at 30, 60, and 120 minutes. Tramadol had an onset time of 15-60 minutes, with peak effectiveness at 2-6 hours postoperatively. Pain level was categorized into 0 (no pain), 1-3 (signifying mild), 4-6 (middle), and 7-10 ( heavy pain).
- Conditions
- Post Operative Analgesia, Tramadol
- Being tested
- Post Operative Analgesia
- Keywords
- Tramadol, Post Operative, Minangkabau
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post Operative AnalgesiaDrug
administering 100 mg of intravenous tramadol 30 minutes before the operation is completed
Post Operative AnalgesiaDrug
VAS of 63 patients was determined by injecting tramadol at a dose of 100 mg 30 minutes before the operation was completed. It was observed in the recovery room at 30, 60, and 120 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Determination of Patients' Visual Analogue Scale (VAS) | Other | Pain level was categorized into 0 (no pain), 1-3 (signifying mild), 4-6 (middle), and 7-10 ( heavy pain). Receives: Drug: Post Operative Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Patients' Visual Analogue Scale (VAS)
Pain level was categorized into 0 (no pain), 1-3 (signifying mild), 4-6 (middle), and 7-10 ( heavy pain).
Measured: . It was observed in the recovery room at 30, 60, and 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Jan 2022
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
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 Operative AnalgesiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- VAS of 63 patients was determined by injecting tramadol at a dose of 100 mg 30 minutes before the operation was completed. It was observed in the recovery room at 30, 60, and 120 minutes. Tramadol had an onset time of 15-60 minutes, with peak effectiveness at 2-6 hours postoperatively. Pain level was categorized into 0 (no pain), 1-3 (signifying mild), 4-6 (middle), and 7-10 ( heavy pain).
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
- Sponsor type
- Other government
- Collaborators
- Andalas University
- Responsible party
- Principal investigator, Desriani Desriani, Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642480
- Sponsor's protocol ID
- BRIN
- Other IDs
- 2/III/HK/2022
- Acronym
- Tramadol
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Effendi R, Rizqia Haz A, Muhammad Fuad A, Dermawan B, Utami N, Desriani. Distribution of CYP2D6 multiplication, CYP2D6*5, and clinical implications in postoperative patients receiving tramadol analgesia in the Minangkabau ethnic group, Indonesia. F1000Res. 2025 Sep 23;13:1526. doi: 10.12688/f1000research.155988.3. eCollection 2024.
PubMed 41078883
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Patients' Visual Analogue Scale (VAS) in Postoperative Patients Receiving Tramadol Analgesia in the Minangkabau Ethnic Group, Indonesia
- ClinicalTrials.gov ID
- NCT06642480
- Acronym / sponsor ID
- Tramadol / BRIN
- Conditions
- Post Operative Analgesia, Tramadol
- Keywords
- Tramadol, Post Operative, Minangkabau
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, IndonesiaOther government
- Collaborators
- Andalas University
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 15 Oct 2024 (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.
Cytochrome P450 2D6 (CYP2D6) is an important enzyme in metabolizing commonly used drugs such as Tramadol hydrochloride (widely used opioid analgesic). Genetic polymorphisms of the CYP2D6 gene have been shown to influence the pharmacodynamic properties of the administered drug. This study aimed to screen 63 postoperative patients (wild-type, CYP2D6*5, and CYP2D6 multiplication) of Minangkabau ethnicity in West Sumatera, Indonesia, who received tramadol using a modified long PCR method and to investigate the clinical impact of tramadol on the patients.
Detailed description
VAS of 63 patients was determined by injecting tramadol at a dose of 100 mg 30 minutes before the operation was completed. It was observed in the recovery room at 30, 60, and 120 minutes. Tramadol had an onset time of 15-60 minutes, with peak effectiveness at 2-6 hours postoperatively. Pain level was categorized into 0 (no pain), 1-3 (signifying mild), 4-6 (middle), and 7-10 ( heavy pain).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- VAS of 63 patients was determined by injecting tramadol at a dose of 100 mg 30 minutes before the operation was completed. It was observed in the recovery room at 30, 60, and 120 minutes. Tramadol had an onset time of 15-60 minutes, with peak effectiveness at 2-6 hours postoperatively. Pain level was categorized into 0 (no pain), 1-3 (signifying mild), 4-6 (middle), and 7-10 ( heavy pain).
| Arm | Type | Receives |
|---|---|---|
| Determination of Patients' Visual Analogue Scale (VAS) | Other | Drug: Post Operative AnalgesiaPain level was categorized into 0 (no pain), 1-3 (signifying mild), 4-6 (middle), and 7-10 ( heavy pain). |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Post operative patients who get analgesic tramadol
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| Post Operative Analgesiaadministering 100 mg of intravenous tramadol 30 minutes before the operation is completed | Drug | Determination of Patients' Visual Analogue Scale (VAS) |
| Post Operative AnalgesiaVAS of 63 patients was determined by injecting tramadol at a dose of 100 mg 30 minutes before the operation was completed. It was observed in the recovery room at 30, 60, and 120 minutes. | Drug | Determination of Patients' Visual Analogue Scale (VAS) |
Primary outcome
Determination of Patients' Visual Analogue Scale (VAS)
Time frame: . It was observed in the recovery room at 30, 60, and 120 minutes
Pain level was categorized into 0 (no pain), 1-3 (signifying mild), 4-6 (middle), and 7-10 ( heavy pain).
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 24 Oct 2024.
- Derived from this study: PubMed 41078883Effendi R, Rizqia Haz A, Muhammad Fuad A, Dermawan B, Utami N, Desriani. Distribution of CYP2D6 multiplication, CYP2D6*5, and clinical implications in postoperative patients receiving tramadol analgesia in the Minangkabau ethnic group, Indonesia. F1000Res. 2025 Sep 23;13:1526. doi: 10.12688/f1000research.155988.3. eCollection 2024.
- Individual participant dataSharing planned: No
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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?
A study testing Post Operative Analgesia in people with Post Operative Analgesia and Tramadol, run by Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia at 1 site in Indonesia.
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 1 inclusion and 1 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 24 Oct 2024. 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 Indonesia. 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?
Determination of Patients' Visual Analogue Scale (VAS) (time frame: . It was observed in the recovery room at 30, 60, and 120 minutes). 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 NCT06642480, 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 24 Oct 2024.