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Effects of Perioperative Pregabalin for Post-Craniotomy Pain

This study has been withdrawn prior to enrollment.
(Pfizer Canada and the SMH ORA could not come into an agreement on responsibility to be the Importer of Record for the trial.)
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01591980
First received: December 9, 2011
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Chronic Postoperative Pain
Headache
Drug: Pregabalin
Drug: pregabalin
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Perioperative Low-dose Pregabalin on Post-craniotomy Pain: A Two-centre Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Chronic post-craniotomy pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The primary outcome of this study will be the incidence of chronic post-craniotomy pain at 3 months


Secondary Outcome Measures:
  • neuropathic component of the pain at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • incidence of long-term pain at days 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • incidence of long-term pain at day 14 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • incidence of long-term pain at day 30 [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
  • total opioid consumption in the first 24h [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • total patient-controlled analgesia (PCA)demands and delivered doses in 24h [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • post-operative pain scores at 24h [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • post-operative pain scores at 48h [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • incidence and severity of opioid-related side effects at day 2 [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
  • incidence and severity of opioid-related side effects at Day 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • consumption of antiemetics in the first 24h [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • tracheal extubation time [ Time Frame: within 24 hours ] [ Designated as safety issue: No ]
  • length of hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: August 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregabalin 100 mg 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.
Other Name: Lyrica
Experimental: pregabalin 150 mg 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.
Other Name: Lyrica
Sham Comparator: Placebo Drug: placebo
Identical placebo capsules will be administered in the same way.
Other Name: Identical placebo capsules

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591980

Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Andrea Rigamonti, MD St. Michael's Hospital, Toronto
  More Information

No publications provided

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01591980     History of Changes
Other Study ID Numbers: REB-10-388
Study First Received: December 9, 2011
Last Updated: February 18, 2014
Health Authority: Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
post-craniotomy pain
pregabalin
chronic post-craniotomy headache
Craniotomy

Additional relevant MeSH terms:
Headache
Pain, Postoperative
Nervous System Diseases
Neurologic Manifestations
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Gamma-Aminobutyric Acid
Pregabalin
Analgesics
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
GABA Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014