A clinical trial to compare two methods of giving Lumbosacral Plexus Block, one using both ultrasound and peripheral nerve stimulator, and the other using peripheral nerve stimulator alone, for pain relief to patients after lower limb surgery

Phase 2/3

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/06/054154
• Lead Sponsor: Department of Anaesthesia

Brief Summary

This study is a prospective, randomized, parallel group trial comparing the efficacy of ultrasound assisted peripheral nerve stimulator guided versus peripheral nerve stimulator guided lumbosacral plexus block (LPSB) for postoperative analgesia in terms of patient satisfaction, time taken for the procedure, ease of administration, number of pricks, duration of analgesia, postoperative analgesic requirement and haemodynamic parameters associated with the procedure in patients undergoing elective unilateral lower limb surgery. The study will be conducted in Government Medical College, Amritsar on 60 ASA grade I-II patients of either sex in the age group of 20 to 60 years scheduled for lower limb orthopaedic surgery under spinal anaesthesia, randomly divided into two groups of 30 patients each- Group ’U’ will receive LSPB using ultrasound assisted peripheral nerve stimulator guided technique and Group ’P’ will receive LSPB using peripheral nerve stimulator guided technique. The data thus obtained will be analyzed and compared statistically.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-07
• Last Update Posted: 2023-06-19

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients belonging to ASA grade I and II Patients undergoing elective unilateral lower limb surgery Patients with normal neurological status Co-operative patients.

Exclusion Criteria

Refusal by patient for the procedure or to enlist in study Patients belonging to ASA grade III or IV Patients with coagulation disorders or on anticoagulation therapy Patients with history of allergy to local anaesthetic drugs Local infection at the site of block Patients with known neuropathies Morbidly obese patients Pregnant females Patients undergoing bilateral lower limb surgery.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Procedural Time (Time required to complete the block)	Time from start of procedure till 24 hours after surgery
Duration of sensory block	Time from start of procedure till 24 hours after surgery
Total dose of rescue analgesia in 24 hours	Time from start of procedure till 24 hours after surgery
Number of pricks taken in each block	Time from start of procedure till 24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Haemodynamic changes	Side effects & complications including number of inadvertent vessels punctured

Trial Locations

Locations (1)

Government Medical College, Amritsar; 🇮🇳 Amritsar, PUNJAB, India

Government Medical College, Amritsar

🇮🇳Amritsar, PUNJAB, India

Dr Alisha Gupta

Principal investigator

8283900864

gupta.alisha2498@gmail.com