Effects of Perioperative Pregabalin for Post-Craniotomy Pain

Overview

Objective: To compare the incidence of chronic pain at 3 months among adults undergoing craniotomy between those received two different doses of pregabalin and those receiving placebo.

Full Title of Study: “Effects of Perioperative Low-dose Pregabalin on Post-craniotomy Pain: A Two-centre Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2014

Detailed Description

Hypothesis: Perioperative pregabalin will reduce the incidence of chronic post-operative pain, and will reduce the opioid consumption, opioid-related side effects, and hospital length of stay compared with placebo in patients undergoing elective craniotomy. Methods: 316 adults (18-65y), ASA I-III, undergoing elective craniotomy will be randomized to receive: 100mg or 150mg pregabalin or placebo once pre-operatively and 50mg or 75mg or placebo twice daily for 14 post-operative days. NRS pain scores, opioid consumption and side effects will be assessed up to 48h, and long-term pain at days 7, 14, 30, and 90. The primary analysis will involve the comparison between the 2 treatment groups together vs. placebo. A stepwise method will be used to evaluate the pairwise comparisons. Outcomes: The primary outcome will be the incidence of chronic post-craniotomy pain at 3 mos. Important secondary outcomes are: neuropathic component of pain at 3 mos., total opioid consumption in the first 24h, and incidence and severity of opioid-related side effects at days 1, 2 and 7.

Interventions

  • Drug: Pregabalin
    • Pre-operatively, one of the 2 doses of pregabalin (100 or 150 mg) or placebo will be given to patients 1 hour before the surgery. Post-operatively, patients will receive daily (split in 2 equal doses) pregabalin 100 mg, pregabalin 150 mg, or placebo for the first 14 post-operative days.
  • Drug: pregabalin
    • Pre-operatively, one of the 2 doses of pregabalin (100 or 150 mg) or placebo will be given to patients 1 hour before the surgery. Post-operatively, patients will receive daily (split in 2 equal doses) pregabalin 100 mg, pregabalin 150 mg, or placebo for the first 14 post-operative days.
  • Drug: placebo
    • Identical placebo capsules will be administered in the same way.

Arms, Groups and Cohorts

  • Experimental: Pregabalin 100 mg
  • Experimental: pregabalin 150 mg
  • Sham Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Chronic post-craniotomy pain
    • Time Frame: 3 months
    • The primary outcome of this study will be the incidence of chronic post-craniotomy pain at 3 months

Secondary Measures

  • neuropathic component of the pain at 3 months
    • Time Frame: 3 months
  • incidence of long-term pain at days 7
    • Time Frame: Day 7
  • incidence of long-term pain at day 14
    • Time Frame: Day 14
  • incidence of long-term pain at day 30
    • Time Frame: Day 30
  • total opioid consumption in the first 24h
    • Time Frame: 24 hours
  • total patient-controlled analgesia (PCA)demands and delivered doses in 24h
    • Time Frame: 24 hours
  • post-operative pain scores at 24h
    • Time Frame: 24 hours
  • post-operative pain scores at 48h
    • Time Frame: 48 hours
  • incidence and severity of opioid-related side effects at day 2
    • Time Frame: Day 2
  • incidence and severity of opioid-related side effects at Day 7
    • Time Frame: Day 7
  • consumption of antiemetics in the first 24h
    • Time Frame: 24 hours
  • tracheal extubation time
    • Time Frame: within 24 hours
  • length of hospital stay
    • Time Frame: 30 days

Participating in This Clinical Trial

Inclusion Criteria

  • Adults, 18 to 65 years (limited to 65 years to lower the risk of over-sedation for elderly patients) – Undergoing elective craniotomy (supratentorial or infratentorial) under general anaesthesia for: biopsy or resection of a tumour, clipping of an unruptured aneurysm, or excision of an arteriovenous malformation – ASA physical status I-III Exclusion Criteria:

  • predicted need for prolonged post-operative ventilation (> 12 hours) – chronic pain secondary to previous craniotomy – known adverse reaction to drugs used (gabapentin, pregabalin, hydromorphone, and/or acetaminophen) – prior use of pregabalin or gabapentin (within 2 weeks before surgery) – current history of moderate to severe headaches (NRS ≥ 4) related to intracranial pathology (tumour pain) since it may be difficult to discriminate between ongoing tumour pain and surgery-related post-operative pain – current history of migraines – pre-existing chronic pain requiring chronic opioid use (30mg morphine equivalent within 4 weeks of surgery) – currently taking any drug that could interact with pregabalin – current history of alcohol or recreational drug abuse – known or suspected addiction to narcotic substances or chronic narcotic use in the last 2 weeks – history of malignant hyperthermia (contraindicates the anaesthesia protocol of this study) – history of angioedema – Body Mass Index ≤ 18.4 or ≥ 35 – history of untreated obstructive sleep apnea – any condition that would contraindicate the use of patient-controlled analgesia (PCA) – lacks fluency in English – pre-existing renal impairment (for pregabalin elimination) – pregnancy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Unity Health Toronto
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Andrea Rigamonti, MD, Principal Investigator, Unity Health Toronto

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.