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

Phase 2

Not yet recruiting

• Conditions: Cholecystectomy; Hernia, Abdominal; Appendectomy; Open Colorectal Surgery; Laparatomy; Postoperative Pain; Hysterectomy; Cystectomy
• Interventions: Drug: Nalbuphine Injection

• Registration Number: NCT06996561
• Lead Sponsor: Dr. Asma Abdus Salam

Brief Summary

The goal of this study is to identify the genes as well as their association with Nalbuphine. This will help us identify opioid vulnerability in our 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.

Detailed Description

The available data suggests that nalbuphine, tramadol, and morphine exhibit comparable efficacy in treating moderate to severe postoperative pain. However, significant individual variations exist in the analgesic response, which can be attributed to genetic differences. These are the variations that are influenced by a combination of demographic, clinical, and environmental factors with a significant contribution from genetic factors that regulate receptor function and signal transduction. Due to the limited availability of morphine, nalbuphine is an extensively used alternative for managing intraoperative and postoperative pain in many LMICs, particularly in Pakistan. While nalbuphine is clinically effective, there is a gap in understanding the molecular factors that contribute to its efficacy in our genetically distinct population. This highlights the need to investigate the genetic variability within our population and to establish the analgesic efficacy of nalbuphine within Pakistani population. There is no molecular data from our region, which highlights the importance of genetic testing to tailor opioid therapy to individual needs, optimizing pain management while minimizing risks such as overdose or inadequate pain relief. By implementing genetics into our clinical practice, we can offer more personalized, effective, and safer opioid use, addressing the challenges associated with opioid therapy in diverse patient populations.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-21
• Study First Submitted QC: 2025-05-21
• Last Update Submitted: 2025-05-21
• Study First Posted: 2025-05-30
• Last Update Posted: 2025-05-30
• Study Start: 2025-07-01
• Primary Completion: 2027-01-01
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 263

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nalbuphine	Nalbuphine Injection	Given as intravenously, 0.1-0.2 mg / kg at induction and intermittently

Primary Outcome Measures

Name	Time	Method
pain score	24 hours postoperatively	Zero is equivalent to no pain and 10 indicates the worst possible pain

Secondary Outcome Measures

Name	Time	Method
sedation score	24 hours	Sedation will be assessed as 0=no sedation, 1= mild sedation, (eye-opening on verbal commands), 2= moderate sedation (eye-opening on painful stimulus), 3= deep sedation (not waking up on pain).
nausea vomiting score	24 hours postoperatively	o as no nausea and vomiting and 3 as continous vomiting despite giving antiemetic
rescue analgesia	24 hours postoperatively	How much nalbuphine ( opioid) in mg was needed in 24 hours. will signify those not responding to conventional analgesia

Trial Locations

Locations (1)

Ziauddin University; 🇵🇰 Karachi, Sindh, Pakistan