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

Not Applicable

Recruiting

• Conditions: Lumbar Spine Disease
• Interventions: Procedure: Skin infiltration LA; Procedure: Erector spinae plane block

• Registration Number: NCT06270654
• Lead Sponsor: University of Malaya

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.

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-08-28
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-13
• Last Update Submitted: 2024-02-13
• Study First Posted: 2024-02-21
• Last Update Posted: 2024-02-21
• Primary Completion: 2024-05-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Skin infiltration LA	Pre incision of 0.375% ropivacaine 10ml local infiltration will be given.
Ropivacaine group	Erector spinae plane block	Bilateral erector spinae plane block (0.375% 20ml ropivacaine on each side + adrenaline 1:200,000) pre incision.

Primary Outcome Measures

Name	Time	Method
Pain score at recovery, 30mins, 1, 2, 4, 8,12, 24 hours post-surgery	24 hours	Measure by numerical rating scale (minimum 1-least pain, maximum 10-most painful)
Total opioid consumption intraoperative	48 hours	Measure by total dose consumed (in milligram)
Total opioid consumption post-operative	up to 72 hours	Measure by total dose consumed (in milligram)
Timing of first rescue dose of iv morphine	up to 24 hours	Post operation till time requiring first dose of iv morphine

Secondary Outcome Measures

Name	Time	Method
The quality of recovery score (QoR)-15 questionnaire at 24 hours post-operation	24 hours	Measure by the quality of recovery score (QoR)-15 questionnaire (minimum of 0,maximum of 150,higher score means a better outcome)
Length of hospital stays	up to 1 week	Days of stay in hospital
Time to ambulation after surgery	up to 1 week	Time from operation till ambulation
Hemodynamic changes intraoperative	Intraoperative period	heart rate (heart rate measure via heart beats per minute/ECG)

Trial Locations

Locations (1)

Universiti Malaya Medical Centre; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan, Malaysia