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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorDr. Asma Abdus Salam

About this trial

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

Qualifiers

All adult men or women

Age 18 to 70 years

ASA criteria 1,2 and 3

Abdomino-pelvic surgeries (open hernia repair, appendicectomy, open cholecystectomy, laparotomy, hysterectomy, cystectomy) lasting 2-4 hours

Disqualifiers

Surgical procedure duration lasting more than 4 hours

Patients taking anti fungal fluconazole, anticoagulant (Warfarin or Clopidogrel) SNRI (Amitryptalline), Rifampicin or Buprenorphine,

History of hypersensitivity or allergy to opioids,

Pregnant or breastfeeding mothers,

Trial design

Treatments tested in this trial

  • Nalbuphine Injection
  • Next Generation Sequencing
  • whole exome sequencing

Treatment groups

263 Participants
are divided into 1 treatment group

Sponsors and collaborators

Dr. Asma Abdus Salam

Lead sponsor

Ziauddin University

Sponsor institution