Not Yet RecruitingPhase 2Phase 3ACTRN12617000889358

Efficacy of Perioperative Pregabalin as an Adjunct in Adolescent Scoliosis Surgery

Randomised Controlled Trial of Perioperative Pregabalin as an Adjunct in Adolescent Idiopathic Scoliosis Surgery - effect on post-operative pain control and anxiety score


Sponsor

Associate Professor Dr. Mohd Shahnaz Hasan

Enrollment

68 participants

Start Date

Jul 1, 2017

Study Type

Interventional

Conditions

Summary

Scoliosis surgery is a major operative procedure and is often linked with severe post-operative pain. Opioids administered either intravenously, subcutaneously, intrathecally or via epidural route are the mainstay for management of acute post-operative pain after scoliosis surgery. However, opioids administration regardless of route is associated with adverse effects such as post-operative nausea and vomiting (PONV), sedation, dry mouth, pruritus, and respiratory depression, all of which are undesirable in the post-operative period. Furthermore, use of opioids alone does not totally abort acute post-operative pain after scoliosis surgery. Therefore, emphasis has been placed on concept of multimodal analgesia, where non-opioids are used in conjunction with opioids in an effort to reduce opioids use, and thus reduce its side effect. This approach also improves pain control due to different sites and mechanisms of pain modulation. Traditionally, non-opioids used are systemic Non-Steroidal Anti-Inflammatory Drugs (NSAIDS), systemic Cyclo-Oxygenase-2 (COX-2) inhibitors, and local anaesthetics infiltration at operative site. Recently, anti-neuropathics such as gabapentin and pregabalin, both of which are a2d receptor modulators and are commonly used in chronic pain syndrome, have also been shown to be efficacious in controlling acute post-operative pain in a variety of surgeries. Common side effect of oral pregabalin includes sedation, dizziness, visual disturbances, dry mouth, and headache. In paediatric age group, pregabalin has been prescribed for neuropathic pain, epilepsy and dysautonomic crisis. In terms of spine surgery, efficacy of pregabalin has been focused on lumbar discectomy, laminectomy or spinal fusion, which involves only 1-3 spinal segments. Use of pregabalin in scoliosis, often involving more spinal segments, has not been determined. As standard practice in University Malaya Medical Center (UMMC), all patients undergoing corrective scoliosis surgery will receive patient controlled analgesia (PCA) morphine and oral paracetamol 15mg/kg 6 hourly after surgery. Based on our experience this group of patients still complained of pain on discharge home. Therefore in this research we aim to establish the efficacy of perioperative pregabalin as adjunct for post operative pain control in this group of patients.


Eligibility

Sex: Both males and femalesMin Age: 10 YearssMax Age: 21 Yearss

Inclusion Criteria2

  • Patients who will be undergo elective single-staged idiopathic scoliosis surgery in University Malaya Medical Centre, Federal Territory, Malaysia between May 2017 and May 2019
  • American Society of Anesthesiologists (ASA) physical status I and II

Exclusion Criteria6

  • Communication barrier
  • Patients on long term opioids, sedatives or anticonvulsants treatment pre-operatively
  • Known allergy to pregabalin or morphine
  • Diabetes mellitus of any type
  • Impaired renal function
  • Unable to use/ operate a patient controlled analgesic (PCA) device

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

This study aims to determine the efficacy of perioperative pergabalin as an adjunct in adolescent idiopathic scoliosis surgery. A total of 68 patients are assigned into 2 groups - treatment (PRE) gro

This study aims to determine the efficacy of perioperative pergabalin as an adjunct in adolescent idiopathic scoliosis surgery. A total of 68 patients are assigned into 2 groups - treatment (PRE) group vs placebo (PLA) group. The patient will then receive either single dose oral pregabalin 50mg (in the PRE group) or placebo capsule (in the PLA group) preoperatively. In the ward, further 4 more doses of oral pregabalin 50mg or placebo will be served 12 hourly at post-operation 12 hours, 24 hours, 36 hours and 48 hours post-operatively. The following assessments will be carried out at various time intervals : On the day of admission, pre-operation (one hour after drug administration); post operation 0 hour at PACU, post-operation 4 hours; 8 hours; 12 hours; 24 hours; 48 hours; and 72 hours in the ward. 1. Pain assessment VAS/NRS* 2. Total consumption of patient controlled analgesic (PCA) morphine 3. Frequency of breakthrough pain requiring rescue analgesia in PACU 4. Validated Visual Analog Scale for anxiety (VAS-A)* 5. The anxiety component of the Hospital Anxiety Depression Score (HADS)* 6. Richmond Agitation and Sedation Scale (RASS)* 7. Incidence of nausea, vomiting, sedation, headache, dizziness, visual disturbances and dry mouth. To assess incidence of neuropathic pain post-operation, patient will be assessed using painDETECT questionnaire at 2 weeks, 1 month and 6 months post-operation via phone call. Anaesthetic Protocol The standardized anaesthetic protocol will be applied to both groups of patients. All patients are adequately fasted prior to surgery. Induction of anaesthesia is carried out with intravenous Propofol 2-4mg/kg, target-controlled-infusion (TCI) of intravenous Remifentanil with target effect-site concentration (Cet) of 1 to 5 ng/ml (Minto model), and Intravenous rocuronium 0.9mg/kg followed by endotracheal intubation. Anaesthesia is maintained with inhalational Desflurane at Minimum Alveolar Concentration (MAC) of 0.6 to 0.8 and ventilate with 50% oxygen/air mixture. Standard patient’s monitoring includes continuous invasive arterial blood pressure monitoring, heart rate, pulse oximetry, 3-leads electrocardiogram and Bispectral index (BIS) of 40-60. Intraoperative cell salvage technique is use as blood conservation strategy and Ringer’s lactate solution as maintenance fluid therapy. Intraoperative analgesia is provided by TCI Remifentanil at set target of 2-5 ng/ml. Before the surgery is ended, patient will receive the following analgesics: 1. Intravenous Morphine 0.2mg/kg – 45 minutes before skin closure 2. Intravenous Paracetamol 15mg/kg – 30 minutes before skin closure 3. Intravenous Fentanyl 1mcg/kg – 10 minutes before skin closure At the end of operation, patients will be reversed with IV neostigmine 0.05mg/kg and IV atropine 0.02mg/kg, TCI remifentanil tapered off, and patient will be extubated after meeting criteria for extubation. All patients will receive post-operative nausea and vomiting prophylaxis in the form of is IV dexamethasone 0.10 mg/kg at induction and IV ondansetron 0.10 mg/kg at the end of surgery. In post-operative care unit (PACU), patient is connected immediately to PCA morphine with the following protocol is used: bolus 1mg, lock-out 5 minutes, no basal infusion, and 4 hours limit is set at 20 mg. Rescue analgesia is provided by intravenous Fentanyl 0.5mcg/kg each bolus if required in PACU. Post-operation, patient will continue to receive PCA Morphine (for the next 48 hours) in the ward and regular intravenous Paracetamol 15mg/kg 6 hourly (for the first 24 hours; subsequently change to oral Paracetamol) up to hospital discharge.


Locations(1)

Kuala Lumpur, Malaysia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12617000889358


Related Trials