Clinical trial NCT06270654: Management of Perioperative Pain Using Erector Spinae Plane Block in Open Microscopic Lumbar Surgery
Official title: Management of Perioperative Pain Using Erector Spinae Plane Block in Open Microscopic Lumbar Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lumbar Spine Disease
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Age 18-75
* Patients with Glasgow Coma Scale of 15.
* 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

Primary outcomes:
measure: Pain score at recovery, 30mins, 1, 2, 4, 8,12, 24 hours post-surgery
timeFrame: 24 hours
measure: Total opioid consumption intraoperative
timeFrame: 48 hours
measure: Total opioid consumption post-operative
timeFrame: up to 72 hours
measure: Timing of first rescue dose of iv morphine
timeFrame: up to 24 hours
Secondary outcomes:
measure: The quality of recovery score (QoR)-15 questionnaire at 24 hours post-operation
timeFrame: 24 hours
measure: Hemodynamic changes intraoperative
timeFrame: Intraoperative period
measure: Hemodynamic changes intraoperative
timeFrame: Intraoperative period
measure: Length of hospital stays
timeFrame: up to 1 week
measure: Time to ambulation after surgery
timeFrame: up to 1 week
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Universiti Malaya Medical Centre
state: Wilayah Persekutuan
Study officials:
References:
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