Chronic Postoperative PainPhase 4NCT01591980
Effects of Perioperative Pregabalin for Post-Craniotomy Pain
A Phase 4 study testing Pregabalin in people with Chronic Postoperative Pain and Headache, run by Unity Health Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Postoperative Pain, Headache
- What is being tested?
- Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2013to Aug 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Perioperative Low-dose Pregabalin on Post-craniotomy Pain: A Two-centre Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Chronic Postoperative Pain, Headache
- Being tested
- Pregabalin, placebo
- Keywords
- post-craniotomy pain, pregabalin, chronic post-craniotomy headache, Craniotomy
- Medical subject headings
- Pain, Postoperative, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Lyrica
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.
pregabalinDrug
Also called Lyrica
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.
placeboDrug
Also called Identical placebo capsules
Identical placebo capsules will be administered in the same way.
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin 100 mg | Experimental | Not described Receives: Drug: Pregabalin |
| pregabalin 150 mg | Experimental | Not described Receives: Drug: pregabalin |
| Placebo | Sham comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic post-craniotomy pain
The primary outcome of this study will be the incidence of chronic post-craniotomy pain at 3 months
Measured: 3 months
Secondary outcomes (13)
neuropathic component of the pain at 3 months
Measured: 3 months
incidence of long-term pain at days 7
Measured: Day 7
incidence of long-term pain at day 14
Measured: Day 14
incidence of long-term pain at day 30
Measured: Day 30
total opioid consumption in the first 24h
Measured: 24 hours
total patient-controlled analgesia (PCA)demands and delivered doses in 24h
Measured: 24 hours
post-operative pain scores at 24h
Measured: 24 hours
post-operative pain scores at 48h
Measured: 48 hours
incidence and severity of opioid-related side effects at day 2
Measured: Day 2
incidence and severity of opioid-related side effects at Day 7
Measured: Day 7
consumption of antiemetics in the first 24h
Measured: 24 hours
tracheal extubation time
Measured: within 24 hours
length of hospital stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startAug 2013
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Why it stopped: Pfizer Canada and the SMH ORA could not come into an agreement on responsibility to be the Importer of Record for the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Postoperative PainStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Rigamonti, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591980
- Sponsor's protocol ID
- REB-10-388
- Status last verified
- Feb 2014
- First submitted
- 9 Dec 2011
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Perioperative Low-dose Pregabalin on Post-craniotomy Pain: A Two-centre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01591980
- Acronym / sponsor ID
- REB-10-388
- Conditions
- Chronic Postoperative Pain, Headache
- Keywords
- post-craniotomy pain, pregabalin, chronic post-craniotomy headache, Craniotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Pfizer Canada and the SMH ORA could not come into an agreement on responsibility to be the Importer of Record for the trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 4 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregabalin 100 mg | Experimental | Drug: Pregabalin |
| pregabalin 150 mg | Experimental | Drug: pregabalin |
| Placebo | Sham comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinAlso: LyricaPre-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. | Drug | Pregabalin 100 mg |
| pregabalinAlso: LyricaPre-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. | Drug | pregabalin 150 mg |
| placeboAlso: Identical placebo capsulesIdentical placebo capsules will be administered in the same way. | Drug | Placebo |
Primary outcome
Chronic post-craniotomy pain
Time frame: 3 months
The primary outcome of this study will be the incidence of chronic post-craniotomy pain at 3 months
13 secondary outcomes
neuropathic component of the pain at 3 months
Time frame: 3 months
incidence of long-term pain at days 7
Time frame: Day 7
incidence of long-term pain at day 14
Time frame: Day 14
incidence of long-term pain at day 30
Time frame: Day 30
total opioid consumption in the first 24h
Time frame: 24 hours
total patient-controlled analgesia (PCA)demands and delivered doses in 24h
Time frame: 24 hours
post-operative pain scores at 24h
Time frame: 24 hours
post-operative pain scores at 48h
Time frame: 48 hours
incidence and severity of opioid-related side effects at day 2
Time frame: Day 2
incidence and severity of opioid-related side effects at Day 7
Time frame: Day 7
consumption of antiemetics in the first 24h
Time frame: 24 hours
tracheal extubation time
Time frame: within 24 hours
length of hospital stay
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Rigamonti, MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin in people with Chronic Postoperative Pain and Headache, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic post-craniotomy pain (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2014.