Comparision of two adjuvant opioid drugs fentanyl and nalbuphine used for spinal anaesthesia in lower limb surgeries

Phase 1/2

Not yet recruiting

• Conditions: Biomechanical lesion, unspecified,

• Registration Number: CTRI/2021/05/033463
• Lead Sponsor: Shri B M Patil Medical College

Brief Summary

During preoperative visit patient’s detailed history,general physical examination and systemic examination will be carried out.History of any significant medical illness will be elicited. Airway,respiratory system and cardiovascular system will be assessed.

Only ASA grade І and ІІ patients withinthe age group of 18 to 60 years of either sex undergoing elective lower limb surgerieswill be included in our study. A written informed consent will be taken.

Patientwill be shifted to operation table, IV access will be obtained on forearm with18 Gauge IV cannula and Ringer’s lactate solution 500ml will be infused intravenouslybefore the block. The monitors will be connected to patient which include non-invasiveblood pressure. Oxygen saturation using pulse oximeter.  Baseline PR, BP and SpO2 will be recorded.

Under strict aseptic precautions, lumbarpuncture will be performed in left lateral position by midline approach byusing 26G Quincke spinal needle at L3-L4 intervertebral space and study drugwill be injected intrathecally after confirming clear free flow of CSF. Patient’svitals will be monitored continuously using mutli-parameter monitor. Afterspinal anaesthesia, Oxygen (5L/min) by facemask will be given, Fluid therapywill be maintained with Lactated Ringer’s solution (10ml/kg/hr).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-17
• Last Update Posted: 2021-06-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Adult patients aged between 18-60 years of both sex undergoing elective lower limb surgeries.
• Patients belonging to ASA Grade І and ІІ.

Exclusion Criteria

• Infection at the site of injection.
• Hypersensitivity to study drugs.
• Coagulopathy or other bleeding diathesis.
• Patients with peripheral neuropathy.
• Patients with cardiac, pulmonary, hepatic or renal disorder.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the onset and duration of sensory and motor blockade of fentanyl and nalbuphine adjuvant to bupivacaine.	At 0, 5, 10, 15, 30, 60 and 120 minute and time of rescue analgesia.

Secondary Outcome Measures

Name	Time	Method
To compare the haemodynamic changes like heart rate and blood pressure, Time of rescue analgesia and Side effects of study drugs.

Trial Locations

Locations (1)

Shri B M Patil Medical College; 🇮🇳 Bijapur, KARNATAKA, India

Shri B M Patil Medical College

🇮🇳Bijapur, KARNATAKA, India

Swathi N R

Principal investigator

9986745669

drswathinr@gmail.com