NCT01591980

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 4, 2012

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

1 year

First QC Date

December 9, 2011

Last Update Submit

February 18, 2014

Conditions

Chronic Postoperative PainHeadache

Keywords

post-craniotomy painpregabalinchronic post-craniotomy headacheCraniotomy

Outcome Measures

Primary Outcomes (1)

  • Chronic post-craniotomy pain

    The primary outcome of this study will be the incidence of chronic post-craniotomy pain at 3 months

    3 months

Secondary Outcomes (13)

  • neuropathic component of the pain at 3 months

    3 months

  • incidence of long-term pain at days 7

    Day 7

  • incidence of long-term pain at day 14

    Day 14

  • incidence of long-term pain at day 30

    Day 30

  • total opioid consumption in the first 24h

    24 hours

  • +8 more secondary outcomes

Study Arms (3)

Pregabalin 100 mg

EXPERIMENTAL
Drug: Pregabalin

pregabalin 150 mg

EXPERIMENTAL
Drug: pregabalin

Placebo

SHAM COMPARATOR
Drug: placebo

Interventions

pregabalinDRUG

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.

Also known as: Lyrica
Pregabalin 100 mg
placeboDRUG

Identical placebo capsules will be administered in the same way.

Also known as: Identical placebo capsules
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Pain, PostoperativeHeadache

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Andrea Rigamonti, MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2011

First Posted

May 4, 2012

Study Start

August 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations

CA(1)