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.
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
Parnandi Bhaskar Rao
All India Institute of medical sciences, Bhubaneswar
