Phase 4
N=15
Pregabalin and Post-thoracotomy Pain
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT00663962 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: The Primary Outcome Measure for the Final Study Will be the Incidence of CPTPS at 2 Months.
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pregabalin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Queen's University
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Outcome Measure for the Final Study Will be the Incidence of CPTPS at 2 Months. |
— | — |
| PRIMARY Incidence of Chronic Post-thoracotomy Pain at 2 Months Postoperatively |
0; 0 | — |
Summary
With Institutional Ethics Board approval and signed informed consent, a pilot investigation was conducted in which 15 adult patients scheduled to undergo a thoractomy were randomly assigned to receive 1) 150 mg pregabalin 1 hour preoperatively and then 7 days postoperatively (BID) or 2) 300 mg pregabalin 1 hour preoperatively and 7 days postoperatively (BID) or 3) placebo for same regimen to assess the feasibility, safety and compliance of this drug regimen on this patient population. This assessment was necessary in order to plan a future fully powered randomized controlled trial looking at the efficacy of perioperative pregabalin ifor reducing the incidence/severity of chronic post-thoracotomy pain.
Eligibility Criteria
Inclusion Criteria
- Elective thoracotomy (ET) or video assisted thoracotomy (VAT);
- Understanding and provision of written informed consent;
- Age > 18 and 1.5 x upper limit of normal);
- BMI > 40;
- Confounding procedural factors which might affect validity of data;
- Surgery for tumour extending into the chest wall;
- Requirement for second thoracotomy or re-occurrence of disease after surgery;
- Potential interaction with study medications and patient's current medications;
- Current ETOH or substance abuse;
- Pre-existing chronic pain requiring chronic analgesic use;
- History of seizure disorder requiring treatment with an anti-convulsant;
- Current therapy with thiazolidinedione class oral hypoglycemic agents (e.g. Actos, Avandia, or Avandamet);
- History of congestive heart failure;
- Major psychiatric disorder;
- Insufficient safety data in a specific patient population;
- Pregnant or breastfeeding.
Data sourced from ClinicalTrials.gov (NCT00663962). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.