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Pregabalin and Post-thoracotomy Pain

Primary Purpose

Chronic Pain

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Pregabalin
Placebo
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Thoracotomy, Post-surgical, Pregabalin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Elective thoracotomy (ET) or video assisted thoracotomy (VAT);
  • Understanding and provision of written informed consent;
  • Age > 18 and < 75;
  • ASA class I, II or III.

Exclusion Criteria:

  • Inability to adhere to study protocol;
  • Intolerance or known hypersensitivity to any agents to be used in the study;
  • Contraindication to thoracic epidural placement in open thoracotomy patients;
  • Inability to respond to the study questionnaire;
  • Renal insufficiency (serum creatinine > 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.

Sites / Locations

  • Kingston General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Perioperative pregabalin

Placebo control

Arm Description

Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-operatively (n=3) or Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-operatively (n=4).

An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)

Outcomes

Primary Outcome Measures

The Primary Outcome Measure for the Final Study Will be the Incidence of CPTPS at 2 Months.
Incidence of Chronic Post-thoracotomy Pain at 2 Months Postoperatively
Incidence of post-thoracotomy pain syndrome (persistent continuous or intermittent chest pain with resting pain score > 4 on a 10 point NRS scale)

Secondary Outcome Measures

Full Information

First Posted
April 18, 2008
Last Updated
January 29, 2016
Sponsor
Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT00663962
Brief Title
Pregabalin and Post-thoracotomy Pain
Official Title
A Prospective, Randomized, Double Blinded, Placebo Controlled Pilot Study Assessing the Effect of Perioperative Pregabalin on the Incidence of Chronic Post Thoracotomy Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
Chronic post thoracotomy pain syndrome (CPTPS) is a significant problem that has important effects on patients' daily activities. The severity of postoperative pain and the central sensitization associated with it are thought to play a role in the chronification of acute pain. Gabapentin has been shown to be effective in reducing acute post-surgical pain and treating CPTPS. There is conflicting data regarding its effects on the development of chronic post-surgical pain. Although pregabalin is similar to gabapentin there are only a few studies examining its use in the modification of post-surgical pain but evidence suggests that it might be effective. There are no studies examining the effect of pregabalin on the development of chronic post-surgical pain. Our hypothesis is that perioperative use of pregabalin will decrease the incidence of CPTPS. Our ultimate goal is to conduct a multi-center study assessing the effect of perioperative oral pregabalin on the development of CPTPS. Prior to this, we will carry out a prospective, randomized, placebo controlled, double-blinded pilot study to assess the feasibility, safety, and compliance associated with perioperative use of oral pregabalin in patients undergoing video assisted thoracotomy surgery (VATS) or open thoracotomy procedures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Thoracotomy, Post-surgical, Pregabalin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Perioperative pregabalin
Arm Type
Experimental
Arm Description
Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-operatively (n=3) or Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-operatively (n=4).
Arm Title
Placebo control
Arm Type
Placebo Comparator
Arm Description
An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
PHASE 1 (N=3) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. PHASE 2 (N=4) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op (N=8)
Primary Outcome Measure Information:
Title
The Primary Outcome Measure for the Final Study Will be the Incidence of CPTPS at 2 Months.
Time Frame
2, 4, and 6 months
Title
Incidence of Chronic Post-thoracotomy Pain at 2 Months Postoperatively
Description
Incidence of post-thoracotomy pain syndrome (persistent continuous or intermittent chest pain with resting pain score > 4 on a 10 point NRS scale)
Time Frame
2 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elective thoracotomy (ET) or video assisted thoracotomy (VAT); Understanding and provision of written informed consent; Age > 18 and < 75; ASA class I, II or III. Exclusion Criteria: Inability to adhere to study protocol; Intolerance or known hypersensitivity to any agents to be used in the study; Contraindication to thoracic epidural placement in open thoracotomy patients; Inability to respond to the study questionnaire; Renal insufficiency (serum creatinine > 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge E Zamora, MD
Organizational Affiliation
Department of Anesthesiology Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L2V7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Pregabalin and Post-thoracotomy Pain

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