NCT06996561 Exploring the Impact of Genetic Variations on The Clinical Efficacy of Nalbuphine in Postoperative Pain Management
| NCT ID | NCT06996561 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Dr. Asma Abdus Salam |
| Condition | Cholecystectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 263 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 263 participants in total. It began in 2025-09-01 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to identify the genes as well as their association with Nalbuphine. This will help the investigator to identify opioid vulnerability in Pakistani population in the postoperative patients and will contribute to overcoming the opioid crisis, resulting in better and safer outcomes. Research question is: Is there any association between the underlying genetic variations and the analgesic efficacy of Nalbuphine in postoperative patients? The Research Objectives are 1. To identify the underlying genes in postoperative patients having pain. 2. To find an association between identified genes and nalbuphine clinical efficacy. Procedure: After the written informed consent adult men and women will be enrolled in the study. On the day of surgery in the preoperative area, a 5 ml blood sample will be drawn before surgery and will be sent to laboratory for analysis. After routine hemodynamic monitoring in the operative room, general anesthesia will be given including nalbuphine. Standard routine anesthesia monitoring will be done and maintained while monitoring heart rate, ECG, NIBP oxygen saturation, ETCO2 and temperature. Incremental analgesia will be provided whenever needed. After extubation and shifting to recovery room the 2nd sample of blood will be taken and will be sent for analysis. Pain score, nausea vomiting, sedation, requirement of analgesia will be assessed till 24 hours postoperatively.
Eligibility Criteria
Inclusion Criteria: 1. All adult men or women 2. Age 18 to 70 years 3. ASA criteria 1,2 and 3 4. Abdomino-pelvic surgeries (open hernia repair, appendicectomy, open cholecystectomy, laparotomy, hysterectomy, cystectomy) lasting 2-4 hours Exclusion Criteria: 1. Surgical procedure duration lasting more than 4 hours 2. Patients taking anti fungal fluconazole, anticoagulant (Warfarin or Clopidogrel) SNRI (Amitryptalline), Rifampicin or Buprenorphine, 3. History of hypersensitivity or allergy to opioids, 4. Pregnant or breastfeeding mothers, 5. History of narcotic dependency, addiction, and withdrawal 6. Patients experiencing any adverse side effects or complications during surgical procedure requiring intensive care admission 7. Refusing to participate in the study 8. Surgical procedures utilizing other modes of intraoperative analgesia e.g epidural analgesia or nerve blocks
Contact & Investigator
Talat Mirza, FCPS PhD
STUDY DIRECTOR
Ziauddin University
Frequently Asked Questions
Who can join the NCT06996561 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Cholecystectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06996561 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06996561 currently recruiting?
Yes, NCT06996561 is actively recruiting participants. Contact the research team at asma.salam.azhar@gmail.com for enrollment information.
Where is the NCT06996561 trial being conducted?
This trial is being conducted at Karachi, Pakistan.
Who is sponsoring the NCT06996561 clinical trial?
NCT06996561 is sponsored by Dr. Asma Abdus Salam. The principal investigator is Talat Mirza, FCPS PhD at Ziauddin University. The trial plans to enroll 263 participants.