Lumbar Spine Disease
Conditions
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.
Interventions
PROCEDUREErector 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.
PROCEDURESkin infiltration LA
Pre incision of 0.375% ropivacaine 10ml local infiltration will be given to control group
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic changes intraoperative | Intraoperative period | Blood pressure(measure in mm hg) |
| 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 |
| 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) |
Countries
Malaysia
Outcome results
None listed