Effects of Perioperative Pregabalin for Post-Craniotomy Pain

Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01591980
• Other study ID #: REB-10-388
• Status: Withdrawn
• Phase: Phase 4
• First received: December 9, 2011
• Last updated: February 18, 2014
• Start date: August 2013
• Est. completion date: August 2014

Study information

• Verified date: February 2014
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Postoperative Pain
• Headache
• Pain, Postoperative

Intervention

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.
• 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.
• placebo
Identical placebo capsules will be administered in the same way.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic post-craniotomy pain	The primary outcome of this study will be the incidence of chronic post-craniotomy pain at 3 months	3 months	No
Secondary	neuropathic component of the pain at 3 months		3 months	No
Secondary	incidence of long-term pain at days 7		Day 7	No
Secondary	incidence of long-term pain at day 14		Day 14	No
Secondary	incidence of long-term pain at day 30		Day 30	No
Secondary	total opioid consumption in the first 24h		24 hours	No
Secondary	total patient-controlled analgesia (PCA)demands and delivered doses in 24h		24 hours	No
Secondary	post-operative pain scores at 24h		24 hours	No
Secondary	post-operative pain scores at 48h		48 hours	No
Secondary	incidence and severity of opioid-related side effects at day 2		Day 2	No
Secondary	incidence and severity of opioid-related side effects at Day 7		Day 7	No
Secondary	consumption of antiemetics in the first 24h		24 hours	No
Secondary	tracheal extubation time		within 24 hours	No
Secondary	length of hospital stay		30 days	No