Comparison of ultrasound guided injection of local anesthetic between back muscle planes to direct injection in and around the back muscles, for post operative pain relief after spine surgeries.

Phase 3

Not yet recruiting

• Conditions: Thoracic, thoracolumbar, and lumbosacral intervertebral disc disorders,

• Registration Number: CTRI/2021/06/034407
• Lead Sponsor: Northern railway central hospital

Brief Summary

This study is a randomised control trial comparing the bilateral erector spinae plane [ESP] block with local wound infiltration of anaesthesia [LWIA] for post-operative analgesic efficacy after open lumbar fusion surgery in 46 patients aged 18-75, ASA grade 1-3. This study will be done in Northern Railway Central Hospital, New Delhi. The patients will be grouped into two groups A and B using computer generated numbers. Group A Patients will receive bilateral Erector Spinae Plane (ESP) block using 15 ml of 0.375% ropivacaine on each side prior to surgery [Total dose of ropivacaine 112.5mg]. Group B Patients will receive local infiltration using 22.5 ml of 0.5% ropivacaine at the end of surgery [Total dose of ropivacaine 112.5mg]. Comparision of 24 hour post operative cumulative analgesic consumption between the two groups will be done. Patients in both the groups will be followed for static pain at 0,1,6,12,24 hours using verbal numeric rating scale(VNRS) and dynamic pain at 12, 24 hours using VNRS. Comparision of quality of recovery (QOR-40) score between the two groups will be done at post operative day 2. Post operative nausea and vomiting will be noted And graded according to standard PONV scoring system.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-06-15
• Study Start: 2021-06-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Patients aged 18-75 years old, with American Society of Anaesthesiologists Physical status 1-3 scheduled for open lumbar fusion surgery.

Exclusion Criteria

• Allergy or intolerance to any of the drugs used in the study.
• Kidney, liver, central or peripheral neurologic disease, coagulopathy.
• Pre-existing neurologic or anatomic deficits in the lower extremities.
• Severe psychiatric illness.
• Infection in the intervention region.
• History of narcotic drug use within 24 hours before operation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to compare 24 hour post-operative cumulative analgesic consumption between erector spinae plane (ESP) block with local wound infiltration of anaesthesia (LWIA) after open lumbar spine fusion surgeries.	24 hours post surgery

Secondary Outcome Measures

Name	Time	Method
1. Comparison of static pain, scores between the 2 groups, as assessed by the verbal numeric rating scale (VNRS) at 0, 1, 6, 12 and 24 hours	2. Comparison of dynamic pain score between the 2 groups, as assessed by the verbal numeric rating scale (VNRS) at12 and 24 hours.

Trial Locations

Locations (1)

Northern railway central hospital; 🇮🇳 Delhi, DELHI, India

Northern railway central hospital

🇮🇳Delhi, DELHI, India

Pankaj yadav

Principal investigator

8376985101

dr.pankaj1417@gmail.com