A Clinical trial to study the effect of fentanyl and buprenorphine in spinal anesthesia to decrease the post-operative pain in patients undergoing lower abdominal surgeries.

Phase 4

Not yet recruiting

• Conditions: Umbilical hernia with gangrene,

• Registration Number: CTRI/2024/01/061835
• Lead Sponsor: Mahatma Gandhi Institute Of Medical Science

Brief Summary

Spinal anesthesia is the most common approach for  anesthesia used for lower abdominal surgery.

Adjuvants are often used with local anesthetics for synergistic effects by prolonging duration of block dose requirement. Drugs like morphine, tramadol, fentanyl  are being used in practice.

Currently research has to be done for local anesthetics which have long duration of action with less potential side effects.

There have been many studies done for adjuvants in spinal anesthesia but no specified result available for maximum benefits and minimum side effect. The data remains inconclusive.

This study evaluate the onset ,duration of sensory and motor block, hemodynamic effects, post-operative analgesia and adverse effect of Buprenorphine and Fentanyl given intrathecally with 0.5 % hyperbaric Bupivacaine.

There is paucity of literature especially from Indian scenarios for the current topic and therefore the need for research study on this topic.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-12-24
• Study Start: 2024-01-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• American Society of Anesthesiologist Grade I and II patients.
• Age 18-65 years of either gender.
• Patients undergoing infraumbilical Surgeries.
• Height is more than 4 feet.
• Patients willing to give consent.

Exclusion Criteria

• American Society of Anesthesiologists Grade III and IV patients.
• Patients with known contraindications for spinal anesthesia: bleeding disorders, local infection.
• Patients with cardiovascular instability.
• Patients with comorbidities like Hypertension, Diabetes Mellitus, cardiac diseases, etc.
• Patient with allergy to opioids or history of hypersensitivity to local anesthetics.
• Emergency surgeries.
• Patients with a history of severe PDPH or PONV after spinal anesthesia.
• Patients not willing to give informed written consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the duration of sensory & motor blockade.	15min 30min 45min

Secondary Outcome Measures

Name	Time	Method
1. The onset of sensory & motor blocks was achieved.	2.The level of blockade achieved.

Trial Locations

Locations (1)

Mahatma Gandhi Institute Of Medical Science; 🇮🇳 Wardha, MAHARASHTRA, India

Mahatma Gandhi Institute Of Medical Science

🇮🇳Wardha, MAHARASHTRA, India

Dr Vaishali Sarote

Principal investigator

8530068494

vaishalisarote@mgims.ac.in