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Clinical Trials/NCT06270654
NCT06270654
Recruiting
Not Applicable

Management of Perioperative Pain Using Erector Spinae Plane Block in Open Microscopic Lumbar Surgery

University of Malaya1 site in 1 country40 target enrollmentJune 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lumbar Spine Disease
Sponsor
University of Malaya
Enrollment
40
Locations
1
Primary Endpoint
Pain score at recovery, 30mins, 1, 2, 4, 8,12, 24 hours post-surgery
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The aim of this study is to compare patients receiving bilateral erector spinae block with ropivacaine vs control group in terms of pain score, total opioid consumption, hemodynamic changes intraoperatively, length of hospitalisation , time to ambulation post surgery and quality of recovery.

Detailed Description

Most open spine surgery exacts a high degree of postsurgical pain due to the incision and muscle dissection of the vertebra. The postoperative pain control and early mobilization improve the quality of the surgical care. Inadequate pain relief might result in perioperative morbidity, resulting in prolonged hospital stays. Erector spinae plane block (ESPB) is an interfascial plane block where local anaesthetic is injected in a plane preferably below the erector spinae muscle. It can provide thoracic, abdominal, and even some lower extremity analgesia. It was also theorised that erector spinae plane block can reduce opioid use and provide analgesia for lumbar surgery. The financial cost that is saved by reducing the length of hospital stay, perioperative morbidity will warrant the use of erector spinae plane block in patients undergoing lumbar spine surgery.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
June 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 18-75
  • Patients with Glasgow Coma Scale of
  • American Society of Anaesthesiologists (ASA) Physical Status Classification I - II patients
  • Scheduled for elective, open microscopic lumbar surgery (less than 3 levels) under general anesthesia.

Exclusion Criteria

  • Cognitive impairment
  • Patient refusal
  • Weight\<50kg, \>120kg
  • Allergy to local anesthesia
  • Alcohol/ drug abuse
  • Renal failure or liver failure
  • Coagulopathy/thrombocytopenia
  • Chronic pain with chronic opioid usage
  • Ischemic heart disease

Outcomes

Primary Outcomes

Pain score at recovery, 30mins, 1, 2, 4, 8,12, 24 hours post-surgery

Time Frame: 24 hours

Measure by numerical rating scale (minimum 1-least pain, maximum 10-most painful)

Total opioid consumption intraoperative

Time Frame: 48 hours

Measure by total dose consumed (in milligram)

Total opioid consumption post-operative

Time Frame: up to 72 hours

Measure by total dose consumed (in milligram)

Timing of first rescue dose of iv morphine

Time Frame: up to 24 hours

Post operation till time requiring first dose of iv morphine

Secondary Outcomes

  • The quality of recovery score (QoR)-15 questionnaire at 24 hours post-operation(24 hours)
  • Length of hospital stays(up to 1 week)
  • Time to ambulation after surgery(up to 1 week)
  • Hemodynamic changes intraoperative(Intraoperative period)

Study Sites (1)

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