Comparison of Nalbuphine and Fentanyl in spine surgeries to determine postoperative requirement of Analgesia using PCA - Morphine. - Randomized Control Trial.

INTRODUCTION:

Conventional spine surgeries often involve extensive dissections so result a considerable degree of postoperative pain, it is severe and usually lasts for 3 days.

Adequate pain treatment in these patients is compounded by the fact that the majority of these patients had already suffered from preexisting chronic pain that had been treated with conventional analgesics or narcotics.

This study aims to determine PCA- Morphine requirement postoperatively in patients administered Nalbuphine or Fentanyl during spine surgery.

 STUDY JUSTIFICATION:

Incidence of pain postoperatively in spine surgeries is extremely high despite recent advances.

Over reliance on opioids like Morphine can lead to increased side effects, potential for dependence, and prolonged hospital stay.

Nalbuphine and Fentanyl are commonly used analgesics, but their relative efficacy in reducing postoperative morphine requirements is not well established.

 AIM AND OBJECTIVES:

The aim of this study is to compare the efficacy of Nalbuphine and Fentanyl in managing postoperative pain in spine surgeries, by evaluating the postoperative Morphine requirement through patient-controlled analgesia (PCA) and assessing any differences in opioid-related side effects.

Primary objective:

To determine analgesic requirement of PCA – Morphine postoperatively

Secondary objective:

To assess hemodynamic changes and side effects of Fentanyl.

To assess hemodynamic changes and side effects of Nalbuphine.

STUDY DESIGN:

TYPE OF STUDY**:** Randomized control trial

Duration : 12 months

Randomization: Computer generates random numbers.

Groups allocation: Sealed envelope technique.

 INCLUSION****CRITERIA:

Patients scheduled for elective surgery requiring laryngoscopy and endotracheal intubation.

Age 18-65.

ASA - I & II.

No history of head and neck surgery

Surgery duration less than 120 minutes.

 EXCLUSION CRITERIA:

Allergy.

History of sore throat.

History of upper respiratory tract infection.

Trauma during extubation.

Insertion of laryngoscope more than three times.

Pregnancy or lactation.

METHODOLOGY:

After obtaining consent, patient will be shifted to the OT.

Monitors will be attached.

Premedication will be given with Injection Glycopyrrolate, Injection Ondonsetron, Injection Midazolam.

Patient will be given Injection Fentanyl/Nalbuphine as an opioid.

Patient will be induced with an induction agent, and muscle relaxant according to their weight.

Intraoperative hemodynamic monitoring will be done.

Postoperative analgesia requirement {PCA (Morphine)} will be assessed using VAS score, Richmond Agitation-Sedation scale, Respiratory status, PCA infusion volume, PCA settings.

Group – 1: Patients will be given Fentanyl at 2mcg/kg followed by induction agent and muscle relaxant.

Group – 2: Patients will be given Nalbuphine at 0.2mg/kg followed by induction agent and muscle relaxant.

 STUDY TOOL:

Randomized control trial

Double blinding

Period of study 12 months

Randomization:  Computer generated random numbers.

Group allocation: Sealed envelope technique.

Source of funding: None.

Approvals and Clearance:  We will be obtaining approvals from the SRM scientific committee. The patient information sheet and informed consent form have been included in both English and Tamil.