Comparison of bupivacaine and bupivacaine with nalbuphine in ultrasound-guided popliteal nerve block - A double blinded randomized control study

Phase 3

Not yet recruiting

• Conditions: Other specified mononeuropathies of lower limb,

• Registration Number: CTRI/2025/05/087623
• Lead Sponsor: Jeevakaarunya k m

Brief Summary

This double-blinded randomized controlled study will be conducted to compare the efficacy of bupivacaine with nalbuphine versus bupivacaine with normal saline in ultrasound-guided popliteal nerve blocks for below-knee surgeries. A total of 58 patients aged 18 to 75 years with ASA physical status 1 to 3 will be randomly assigned to two groups. Group A will receive 20 ml of 0.5 percent bupivacaine with 1 ml normal saline, while Group B will receive 20 ml of 0.5 percent Bupivacaine with 10 mg nalbuphine. The primary objective will be to compare the onset and duration of sensory block, while secondary objectives will include motor block characteristics, time to first rescue analgesia, patient satisfaction, and block-related complications. Sensory and motor block onset and duration will be assessed using standardized methods, and pain will be monitored using the Visual Analogue Scale. This study aims to determine whether the addition of nalbuphine provides superior postoperative analgesia without additional side effects, thereby potentially improving pain management protocols for lower limb surgeries .

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-06
• Last Update Posted: 2025-05-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• ASA physical status I, II and III of either sex 2.
• Aged between 18-75 years 3.
• Admitted for below knee surgeries.

Exclusion Criteria

• Patient refusal and cognitive disorders 2.
• Patients with known hypersensitivity or contraindications to the study drugs 3.
• Infection at the site of block 4.
• Patients with advanced renal disease , hepatic or cardiac diseases 5.
• Patients with severe coagulopathy 6.
• Pregnant patients 7.
• Patients with Neuropathic disorder of the affected limb.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Onset and duration of sensory block	1 year

Secondary Outcome Measures

Name	Time	Method
Onset and duration of motor block	1 year
To access the time of first rescue analgesic requirement	1 year
Patient satisfaction	1 year
Complications of popliteal block	1 year

Trial Locations

Locations (1)

Dr Rangarajan Memorial Hospital (Sundaram Medical Foundation); 🇮🇳 Chennai, TAMIL NADU, India

Dr Rangarajan Memorial Hospital (Sundaram Medical Foundation)

🇮🇳Chennai, TAMIL NADU, India

Dr Jeevakaarunya K M

Principal investigator

7867031139

sibirangasamy@gmail.com