How genetic differences affect nalbuphine pain relief after abdominal or pelvic surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Ziauddin University
  Karachi, Sindh, Pakistan Recruiting

Study contacts

• Study coordinator: Asma Abdus Salam, FCPS, MCPS, MBBS
• Email: asma.salam.azhar@gmail.com
• Phone: +923002122264

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.