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Minocycline for the Prevention of Post-operative Intercostal Neuralgia

Primary Purpose

Post-operative Intercostal Neuralgia

Status
Unknown status
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Minocycline
Sponsored by
University of Adelaide
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Intercostal Neuralgia focused on measuring Neuropathic pain, Minocycline

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female
  • Aged 18 years or older
  • Undertaking elective, open thoracotomy with ample time pre-operatively to provide informed consent and undertake dosing
  • Sufficient fluency in English language to read and understand consent form, fulfil study requirements and communicate with research staff
  • Negative pregnancy test at screening for women of child bearing potential
  • Females of child bearing potential must agree to use a medically acceptable method of contraception other than oral contraceptives from time of first dosing until one week post-operatively. Acceptable methods include abstinence, contraceptive patches, NuvaRing (etonogestrel/ethinyl oestradiol vaginal ring), diaphragm with vaginal spermicide, intrauterine device, condom and vaginal spermicide, progestin implant or injection
  • Avoid prolonged, direct sunlight or ultra-violet light exposure during dosing period
  • Refrain from strenuous activities and avoid changes to regular exercise patterns throughout trial period

Exclusion Criteria:

  • Pregnant or breast feeding
  • Known allergy to minocycline and other tetracycline antibiotics
  • Pre-existing neuralgic pain condition in area designated for operation
  • Physical abnormality in area designated for operation
  • Taking disallowed concomitant medication
  • Renal insufficiency as determined by a calculated creatinine clearance of < 60mL/min
  • Hepatic dysfunction as determined by alanine transaminase and/or aspartate transaminase in excess of three times upper normal limits
  • Diagnosis of systemic lupus erythematosus
  • Recent diagnosis of enterocolitis or colitis
  • Participation in another trial of an investigational product within 30 days of commencing dosing or are scheduled to commence trial of an investigational product during study period
  • Patients who, in an Investigator's opinion, should not participate in the trial or may not be capable of following the trial schedule for any reason
  • History of major psychiatric disorder not medically controlled

Sites / Locations

  • Royal Adelaide HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Minocycline

Arm Description

Outcomes

Primary Outcome Measures

Daily pain scores on a numerical rating scale

Secondary Outcome Measures

Hypo/hyperaesthesia to punctate sensation

Full Information

First Posted
March 11, 2011
Last Updated
February 4, 2013
Sponsor
University of Adelaide
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1. Study Identification

Unique Protocol Identification Number
NCT01314482
Brief Title
Minocycline for the Prevention of Post-operative Intercostal Neuralgia
Official Title
The Efficacy of Prophylactic Administration of Minocycline in Reducing Chronic Intercostal Neuralgia Post-thoracotomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
February 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Adelaide

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In about half the patients who have an open chest surgery there is persistent severe pain in the chest. The investigators are examining whether minocycline, a commonly used antibiotic, will prevent pain. Minocycline blocks the activity of immune cells which the investigators believe are responsible for prolonging the pain.
Detailed Description
The study is of double-blind placebo controlled parallel groups design in up to 116 patients undergoing elective open thoracotomy. Minocycline 200mg twice daily or matching placebo are given three days before surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Intercostal Neuralgia
Keywords
Neuropathic pain, Minocycline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Minocycline
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Minocycline
Intervention Description
200mg bd for 3 days before surgery
Primary Outcome Measure Information:
Title
Daily pain scores on a numerical rating scale
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Hypo/hyperaesthesia to punctate sensation
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female Aged 18 years or older Undertaking elective, open thoracotomy with ample time pre-operatively to provide informed consent and undertake dosing Sufficient fluency in English language to read and understand consent form, fulfil study requirements and communicate with research staff Negative pregnancy test at screening for women of child bearing potential Females of child bearing potential must agree to use a medically acceptable method of contraception other than oral contraceptives from time of first dosing until one week post-operatively. Acceptable methods include abstinence, contraceptive patches, NuvaRing (etonogestrel/ethinyl oestradiol vaginal ring), diaphragm with vaginal spermicide, intrauterine device, condom and vaginal spermicide, progestin implant or injection Avoid prolonged, direct sunlight or ultra-violet light exposure during dosing period Refrain from strenuous activities and avoid changes to regular exercise patterns throughout trial period Exclusion Criteria: Pregnant or breast feeding Known allergy to minocycline and other tetracycline antibiotics Pre-existing neuralgic pain condition in area designated for operation Physical abnormality in area designated for operation Taking disallowed concomitant medication Renal insufficiency as determined by a calculated creatinine clearance of < 60mL/min Hepatic dysfunction as determined by alanine transaminase and/or aspartate transaminase in excess of three times upper normal limits Diagnosis of systemic lupus erythematosus Recent diagnosis of enterocolitis or colitis Participation in another trial of an investigational product within 30 days of commencing dosing or are scheduled to commence trial of an investigational product during study period Patients who, in an Investigator's opinion, should not participate in the trial or may not be capable of following the trial schedule for any reason History of major psychiatric disorder not medically controlled
Facility Information:
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Gentgall, RN
Phone
+61 8 82222712
Email
melanie.gentgall@health.sa.gov.au
First Name & Middle Initial & Last Name & Degree
James Swift, BHlthSci(Hons)
Phone
+61 8 82222712
Email
james.swift@adelaide.edu.au
First Name & Middle Initial & Last Name & Degree
Craig Jurisevic, MD
First Name & Middle Initial & Last Name & Degree
Paul E Rolan, MD

12. IPD Sharing Statement

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Minocycline for the Prevention of Post-operative Intercostal Neuralgia

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