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Effects of Perioperative Pregabalin for Post-Craniotomy Pain

Primary Purpose

Chronic Postoperative Pain, Headache

Status
Withdrawn
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Pregabalin
pregabalin
placebo
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Postoperative Pain focused on measuring post-craniotomy pain, pregabalin, chronic post-craniotomy headache, Craniotomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Pregabalin 100 mg

pregabalin 150 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Chronic post-craniotomy pain
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
incidence of long-term pain at days 7
incidence of long-term pain at day 14
incidence of long-term pain at day 30
total opioid consumption in the first 24h
total patient-controlled analgesia (PCA)demands and delivered doses in 24h
post-operative pain scores at 24h
post-operative pain scores at 48h
incidence and severity of opioid-related side effects at day 2
incidence and severity of opioid-related side effects at Day 7
consumption of antiemetics in the first 24h
tracheal extubation time
length of hospital stay

Full Information

First Posted
December 9, 2011
Last Updated
February 18, 2014
Sponsor
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01591980
Brief Title
Effects of Perioperative Pregabalin for Post-Craniotomy Pain
Official Title
Effects of Perioperative Low-dose Pregabalin on Post-craniotomy Pain: A Two-centre Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Pfizer Canada and the SMH ORA could not come into an agreement on responsibility to be the Importer of Record for the trial.
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Postoperative Pain, Headache
Keywords
post-craniotomy pain, pregabalin, chronic post-craniotomy headache, Craniotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin 100 mg
Arm Type
Experimental
Arm Title
pregabalin 150 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Other Intervention Name(s)
Lyrica
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
pregabalin
Other Intervention Name(s)
Lyrica
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
Identical placebo capsules
Intervention Description
Identical placebo capsules will be administered in the same way.
Primary Outcome Measure Information:
Title
Chronic post-craniotomy pain
Description
The primary outcome of this study will be the incidence of chronic post-craniotomy pain at 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
neuropathic component of the pain at 3 months
Time Frame
3 months
Title
incidence of long-term pain at days 7
Time Frame
Day 7
Title
incidence of long-term pain at day 14
Time Frame
Day 14
Title
incidence of long-term pain at day 30
Time Frame
Day 30
Title
total opioid consumption in the first 24h
Time Frame
24 hours
Title
total patient-controlled analgesia (PCA)demands and delivered doses in 24h
Time Frame
24 hours
Title
post-operative pain scores at 24h
Time Frame
24 hours
Title
post-operative pain scores at 48h
Time Frame
48 hours
Title
incidence and severity of opioid-related side effects at day 2
Time Frame
Day 2
Title
incidence and severity of opioid-related side effects at Day 7
Time Frame
Day 7
Title
consumption of antiemetics in the first 24h
Time Frame
24 hours
Title
tracheal extubation time
Time Frame
within 24 hours
Title
length of hospital stay
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Rigamonti, MD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada

12. IPD Sharing Statement

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Effects of Perioperative Pregabalin for Post-Craniotomy Pain

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