Bupivacaine for Subarachnoid block either premixed with Fentanyl or administered before of after it.

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/03/041442
• Lead Sponsor: Mahatma Gandhi Medical College

Brief Summary

Subarachnoid block is the most commonly used anesthesia technique for lower limbsurgeries and hyperbaric Bupivacaine is the most commonly used local anesthetics for it. Several adjuvants or additives including various opioids, alpha agonists, neostigmine, ketamine, dexamethasone have been used mixing with the bupivacaine to enhance the quality of subarachnoid block.

Though the Fentanyl has been used extensively premixed with hyperbaric bupivacaine for spinal anesthesia, there is paucity of literature on clinical effects and understanding of mechanism of influence of fentanyl on subarachnoid block produced by hyperbaric bupivacaine when administered separately by another syringe, either before or after bupivacaine.

We propose that cerebrospinal fluid dynamics and pharmacokinetics may be affected differently when fentanyl is co-administered in subarachnoid space premixed with bupivacaine compared to when administered separately before or after hyperbaric Bupivacaine. That is the rationale of proposal for conducting this clinical study where in we wish to evaluate the difference in onset and duration of sensory and motor block and the incidence of hypotension after administering hyperbaric Bupivacaine and Fentanyl either in a single syringe or in different syringes prior to hyperbaric Bupivacaine and vice versa.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-31
• Study Completion: 2022-06-09
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• 1.Patients scheduled for elective lower limb surgeries under subarachnoid block.
• 2.Patients weighing 50 to 70 kgs.
• 3.Patient under ASA CLASS I/ II /III.
• 4.Patient’s with written and informed consent.

Exclusion Criteria

• 1.Patient belonging to ASA CLASS IV & V.
• 2.Patients allergic to the study drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the Onset and Duration of Sensory and Motor block in minutes.	Intraoperative
To study the variation in Systolic and Diastolic BP, Mean Arterial Pressure, Heart Rate, Respiratory Rate, SPO2.	Intraoperative

Secondary Outcome Measures

Name	Time	Method
1.To assess the need of rescue postoperative analgesia in next 24 hr.	2.To study the postoperative side effects viz Nausea, vomiting, Itching, Urinary retention, respiratory depression etc.

Trial Locations

Locations (1)

mahatma gandhi medical college and hospital; 🇮🇳 Jaipur, RAJASTHAN, India

mahatma gandhi medical college and hospital

🇮🇳Jaipur, RAJASTHAN, India

Dr Avnish Bharadwaj

Principal investigator

9314882845

avnishbharadwaj1@gmail.com