An interventional study of Erector spinae plane block and Skin infiltration LA in Lumbar Spine Disease, sponsored by University of Malaya. Recruiting at 1 site in Malaysia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-02-21.
Sponsored by University of Malaya · Not applicable, Interventional, and Treatment
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.
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.
174 studies on the registry are indexed under Spinal Diseases; 39 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 106 interventional studies indexed under Spinal Diseases.
Browse Spinal Diseases studies →University of Malaya is the lead sponsor of 284 studies on the registry; 58 are open to participants now.
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Exclusion Criteria:
Pre incision of 0.375% ropivacaine 10ml local infiltration will be given.
Procedure: Skin infiltration LA
Bilateral erector spinae plane block (0.375% 20ml ropivacaine on each side + adrenaline 1:200,000) pre incision.
Procedure: Erector spinae plane block
After consent was obtained, patients will be randomised into control group and an intervention group. For patients randomized into the interventional group, bilateral erector spinae plane block will be performed under general anaesthesia in prone position before the operation. An experienced anaesthetist performs this under ultrasound guidance (using curvilinear probe) in a sterile method. After identifying L3 transverse process, 21G Stimuplex needle will be inserted via in-plane method. Once needle placement is confirmed and aspiration is negative, 20ml of ropivacaine 0.375% with adrenaline 1:200,000 dilution will be given on each side.
Pre incision of 0.375% ropivacaine 10ml local infiltration will be given to control group
Pain score at recovery, 30mins, 1, 2, 4, 8,12, 24 hours post-surgery
Measure by numerical rating scale (minimum 1-least pain, maximum 10-most painful)
Time frame: 24 hours
Total opioid consumption intraoperative
Measure by total dose consumed (in milligram)
Time frame: 48 hours
Total opioid consumption post-operative
Measure by total dose consumed (in milligram)
Time frame: up to 72 hours
Timing of first rescue dose of iv morphine
Post operation till time requiring first dose of iv morphine
Time frame: up to 24 hours
The quality of recovery score (QoR)-15 questionnaire at 24 hours post-operation
Measure by the quality of recovery score (QoR)-15 questionnaire (minimum of 0,maximum of 150,higher score means a better outcome)
Time frame: 24 hours
Hemodynamic changes intraoperative
Blood pressure(measure in mm hg)
Time frame: Intraoperative period
Hemodynamic changes intraoperative
heart rate (heart rate measure via heart beats per minute/ECG)
Time frame: Intraoperative period
Length of hospital stays
Days of stay in hospital
Time frame: up to 1 week
Time to ambulation after surgery
Time from operation till ambulation
Time frame: up to 1 week
Plan to share: No
Started Jun 2023 (actual). Primary completion is estimated for May 2024, 11 months after the start.
Of 40 non-industry interventional studies with no phase under Spinal Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 11 months is below that.
Counting every sponsor, half of 43 studies reached it within 26 months; a quarter within 16 and three quarters within 60.
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