Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 70Years
All Genders
ID06996561

Exploring the Impact of Genetic Variations on The Clinical Efficacy of Nalbuphine in Postoperative Pain Management

Led by Dr. Asma Abdus Salam · Updated on 2026-04-15

263

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how genetic differences affect the pain relief provided by nalbuphine in adults undergoing certain abdominal and pelvic surgeries. This trial aims to identify genes linked to pain and how they influence nalbuphine's effectiveness in postoperative patients, focusing on a Pakistani population to help address opioid use challenges and improve pain management. Participants will receive nalbuphine intravenously during surgery, with doses given at induction and as needed based on heart rate and blood pressure. Standard anesthesia with propofol, atracurium, oxygen, nitrous oxide, and isoflurane will be used. Blood samples will be taken before surgery and after extubation for genetic analysis, focusing on patients with persistent pain or opioid side effects. Pain, sedation, nausea, vomiting, and analgesic needs will be monitored for 24 hours after surgery. Participants will be assessed through vital sign monitoring during surgery and pain and sedation evaluations for 24 hours after. Blood samples will be analyzed genetically to explore links between genes and nalbuphine response. Researchers will measure pain scores as the main outcome and track sedation, nausea, vomiting, and additional pain medication use. The study will follow participants from before surgery through 24 hours postoperatively to understand nalbuphine's clinical effects and genetic influences.

CONDITIONS

Brief Title

Exploring the Impact of Genetic Variations on The Clinical Efficacy of Nalbuphine in Postoperative Pain Management

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult men or women aged 18 to 70 years
  • ASA physical status classification 1, 2, or 3
  • Undergoing abdomino-pelvic surgeries such as open hernia repair, appendectomy, open cholecystectomy, laparotomy, hysterectomy, or cystectomy
  • Surgical procedure lasting between 2 and 4 hours
Not Eligible

You will not qualify if you...

  • Surgical procedure lasting more than 4 hours
  • Taking antifungal fluconazole, anticoagulants like warfarin or clopidogrel, SNRI (amitriptyline), rifampicin, or buprenorphine
  • History of allergy or hypersensitivity to opioids
  • Pregnant or breastfeeding women
  • History of narcotic dependency, addiction, or withdrawal
  • Experiencing adverse side effects or complications during surgery requiring intensive care
  • Refusal to participate in the study
  • Use of other intraoperative analgesia methods such as epidural analgesia or nerve blocks

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Surgery duration plus 24 hours postoperatively

Participants receive nalbuphine intravenously during surgery and intermittently as needed for pain control. Pain and sedation levels are monitored for 24 hours after surgery.

1 surgical procedure and monitoring for 24 hours postoperatively

Sample Collection

Duration - During surgery (half an hour before extubation)

Blood samples are collected from participants half an hour before extubation during surgery for genetic analysis. Only selected samples based on pain response are sent for whole exome sequencing.

1 blood draw (in-person)

Trial Site Locations

Total: 1 location

1

Ziauddin University

Karachi, Sindh, Pakistan, 755000

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Research Team

A

Asma Abdus Salam, FCPS, MCPS, MBBS

Z

Zulfiqar Omrani, Director ORIC

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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