Phase 4 Completed N=15 Randomized Quadruple-blind Treatment

Pregabalin and Post-thoracotomy Pain

Postoperative Pain

Source: ClinicalTrials.gov NCT00663962 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2016

Primary outcomePrimary: The Primary Outcome Measure for the Final Study Will be the Incidence of CPTPS at 2 Months.

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.

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	—

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.

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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. Informational only — not medical advice.