Skip to main content
Clinical Trials/CTRI/2024/10/075653
CTRI/2024/10/075653Not yet recruitingPhase 3

Comparative safety and efficacy of three different ultrasound guided approaches to lumbar dorsal rami for pain relief in adults undergoing lumbar spine surgery – a double blind randomized controlled non-inferiority trial.

Parnandi Bhaskar Rao1 site in 1 country100 target enrollmentStarted: October 28, 2024Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
time from block administration to demand of first analgesia by patient after surgery

Study Overview

Brief Summary

Lumbar spine surgery is often associated with severe pain in the perioperative period. Several regional analgesia techniques have been found to be effective in the management of pain in these group of patients [1]. Erector spinae plane block (ESPB) and thoracolumbar interfascial plane block (TLIP) are established regional approaches for effective pain management with reduction in pain scores and opioid consumption [2, 3]. Similarly, lumbar submultifidus muscle block has been introduced recently as a novel regional analgesia technique. This involves instillation of local anaesthetics below the lumbar multifidus muscle to block pain conduction through dorsal rami providing acceptable analgesia following lumbar spine surgery [4]. However, scarce information is available on the comparative safety and efficacy of these approaches for post-operative analgesia for lumbar spine surgery, hence we planned this randomized controlled trial.  

REFERENCES:

1.      Hong B, Baek S, Kang H, Oh C, Jo Y, Lee S, Park S. Regional analgesia techniques for lumbar spine surgery: a frequentist network meta-analysis. Int J Surg. 2023 Jun 1;109(6):1728-1741.

2.      Oh SK, Lim BG, Won YJ, Lee DK, Kim SS. Analgesic efficacy of erector spinae plane block in lumbar spine surgery: A systematic review and meta-analysis. J Clin Anesth. 2022 Jun;78:110647.

3.      Abdildin YG, Salamat A, Omarov T, Sultanova M, Krassavina Y, Viderman D. Thoracolumbar Interfascial Plane Block in Spinal Surgery: A Systematic Review with Meta-Analysis. World Neurosurg. 2023 Jun;174:52-61.

4.      Song L, Ying S, Wang Z, Yuan X. Ultrasound-guided lumbar multifidus block provides effective postoperative analgesia for lumbar spine surgery. J Clin Anesth. 2018 May;46:116-117.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Adult ASA 1 & 2 patients undergoing lumbar spine surgery up to 4 levels with midline incision in prone position.

Exclusion Criteria

  • Those who refuse to participate Sensitive to local anaesthetics Liver and Kidney failure.

Outcomes

Primary Outcomes

time from block administration to demand of first analgesia by patient after surgery

Time Frame: at 0, 4 and 12 hours after surgery

Secondary Outcomes

  • Total tramadol consumption within 24 hours after surgery

Investigators

Sponsor
Parnandi Bhaskar Rao
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Parnandi Bhaskar Rao

All India Institute of medical sciences, Bhubaneswar

Study Sites (1)

Loading locations...

Similar Trials