Effects of Perioperative Pregabalin for Post-Craniotomy Pain - Full Text View

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:

MedlinePlus related topics: Headache

Drug Information available for: Pregabalin

U.S. FDA Resources

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 ]

Estimated Enrollment:	316
Study Start Date:	July 2012
Estimated Study Completion Date:	July 2014
Estimated Primary Completion Date:	June 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

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

Contacts

Contact: Andrea Rigamonti, MD

416-564-6060 ext 5071

rigamontia@smh.ca

Locations

Canada, Ontario
St. Michael's Hospital	Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Principal Investigator: Andrea Rigamonti, MD

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:	May 8, 2012
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
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pregabalin

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on May 22, 2013