How genetic differences affect nalbuphine pain relief after abdominal or pelvic surgery
Exploring the Impact of Genetic Variations on The Clinical Efficacy of Nalbuphine in Postoperative Pain Management
PHASE2; PHASE3 · Ziauddin University · NCT06996561
We will test whether genetic differences change how well nalbuphine relieves pain after abdominal or pelvic surgery in adults.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 263 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Ziauddin University (other) |
| Locations | 1 site (Karachi, Sindh) |
| Trial ID | NCT06996561 on ClinicalTrials.gov |
What this trial studies
This interventional Phase 2/3 study will collect a preoperative blood sample and use next-generation whole exome sequencing to identify genetic variants in adults undergoing open abdomino-pelvic surgeries. All participants receive nalbuphine as part of standard intraoperative and postoperative analgesia, and their pain responses and clinical outcomes will be measured. Investigators will correlate genetic variants with nalbuphine analgesic efficacy to identify markers of opioid sensitivity or resistance within the Pakistani population. The goal is to generate molecular data that could support more personalized and safer opioid use in this setting.
Who should consider this trial
Good fit: Adults aged 18–70, ASA class 1–3, undergoing open abdomino-pelvic surgeries lasting 2–4 hours who can provide informed consent are the intended participants.
Not a fit: Patients with procedures longer than 4 hours, on excluded interacting medications, pregnant or breastfeeding, with opioid allergy or dependency, or receiving epidural/nerve-block analgesia are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the findings could help tailor opioid choice and dosing to patients' genetics, improving pain control and safety after surgery.
How similar studies have performed: Prior clinical work shows nalbuphine, tramadol, and morphine have comparable analgesic effects and opioid pharmacogenetics affects response, but nalbuphine-specific genetic evidence—particularly in Pakistani populations—is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Karachi, Sindh
- Ziauddin University — Karachi, Sindh, Pakistan (RECRUITING)
Study contacts
- Study coordinator: Asma Abdus Salam, FCPS, MCPS, MBBS
- Email: asma.salam.azhar@gmail.com
- Phone: +923002122264
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cholecystectomy, Hernia, Abdominal, Appendectomy, Open Colorectal Surgery, Laparatomy, Postoperative Pain, Hysterectomy, Cystectomy