Nalbuphine vs fentanyl as additive to main drug bupivacaine in spinal anaesthesia.

Phase 2

Not yet recruiting

• Conditions: healthy patients undergoing lower limb surgeries

• Registration Number: CTRI/2024/01/062089
• Lead Sponsor: Dr Virendra Nimbalkar

Brief Summary

Spinal anesthesia remains a popular method of anesthesia for a wide range of surgeries due  to its easiness ,safety features and newer addition drugs with less side effects and more benefits for certain patient populations. However, it is also frequently associated with undesirable effects such as hypotension, bradycardia, and shivering. Rarely, it may cause severe bradycardia and cardiac arrest. Adjuvants or additives are often used with local anesthetics for its synergistic effect by prolonging the duration of sensory-motor block, minimize side effects and limiting the cumulative dose requirement of local anesthetics.

Opioids are the time honoured drugs which have been used for this purpose. Nalbuphine is an agonist-antagonist opioid synthesized to produce analgesia without any unwanted µ agonist side effects like respiratory depression, undesirable sedation, nausea, vomiting and urinary retention.

Fentanyl, a synthetic opioid, has fast onset of action following intrathecal administration due to its high lipid soluble nature. It does not tend to migrate to the fourth ventricle in sufficient concentration to cause delayed respiratory depression when administered intrathecally. In this study. Adjuvants are added to prolong post operative analgesia to increase duration of analgesia and to limit the side effects of increased dose of local anesthetics on hemodynamics.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-01-30
• Study Start: 2024-09-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.American society of anaesthesiologist(ASA) status I and II 2.Age 25-65 years 3.both genders.

Exclusion Criteria

1.Patients with contraindication to spinal anaesthesia 2.Pre-existing neurological deficits 3.Patients with history of allergy to study drugs 4.Pregnant patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
two groups-intrathecal nalbuphine &	Time at which intrathecal drug is administered is | T0, followed by T1 at 1min,T2 at 2 min,T3 at 3 min interval......till intraoperative period followed | by time required for regaining of sensory and | motor sensation in postoperative period.
To evaluate & compare the following factors in	Time at which intrathecal drug is administered is | T0, followed by T1 at 1min,T2 at 2 min,T3 at 3 min interval......till intraoperative period followed | by time required for regaining of sensory and | motor sensation in postoperative period.
intrathecal fentanyl as an adjuvant to	Time at which intrathecal drug is administered is | T0, followed by T1 at 1min,T2 at 2 min,T3 at 3 min interval......till intraoperative period followed | by time required for regaining of sensory and | motor sensation in postoperative period.
hyperbaric bupivacaine in lower limb	Time at which intrathecal drug is administered is | T0, followed by T1 at 1min,T2 at 2 min,T3 at 3 min interval......till intraoperative period followed | by time required for regaining of sensory and | motor sensation in postoperative period.
surgeries with respect to:	Time at which intrathecal drug is administered is | T0, followed by T1 at 1min,T2 at 2 min,T3 at 3 min interval......till intraoperative period followed | by time required for regaining of sensory and | motor sensation in postoperative period.
1. Sensory & motor blockade -onset & duration	Time at which intrathecal drug is administered is | T0, followed by T1 at 1min,T2 at 2 min,T3 at 3 min interval......till intraoperative period followed | by time required for regaining of sensory and | motor sensation in postoperative period.

Secondary Outcome Measures

Name	Time	Method
Duration of analgesia	perioperative to postoperative period

Trial Locations

Locations (1)

Silchar medical college and hospital; 🇮🇳 Cachar, ASSAM, India

Silchar medical college and hospital

🇮🇳Cachar, ASSAM, India

Dr Virendra Nimbalkar

Principal investigator

9673240044

virunimbalkar@gmail.com