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Effects of Perioperative Pregabalin for Post-Craniotomy Pain

Information source: St. Michael's Hospital, Toronto
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Postoperative Pain; Headache

Intervention: Pregabalin (Drug); pregabalin (Drug); placebo (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: St. Michael's Hospital, Toronto

Official(s) and/or principal investigator(s):
Andrea Rigamonti, MD, Principal Investigator, Affiliation: St. Michael's Hospital, Toronto

Overall contact:
Andrea Rigamonti, MD, Phone: 416-564-6060, Ext: 5071, Email: rigamontia@smh.ca

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.

Clinical Details

Official title: Effects of Perioperative Low-dose Pregabalin on Post-craniotomy Pain: A Two-centre Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Chronic post-craniotomy pain

Secondary outcome:

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

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Andrea Rigamonti, MD, Phone: 416-564-6060, Ext: 5071, Email: rigamontia@smh.ca

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

Starting date: July 2012
Last updated: May 8, 2012

Page last updated: February 07, 2013

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