Minocycline for the Prevention of Post-operative Intercostal Neuralgia

Study Overview
=================
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.

Official Title
-----------------
The Efficacy of Prophylactic Administration of Minocycline in Reducing Chronic Intercostal Neuralgia Post-thoracotomy

Conditions
-----------------
Post-operative Intercostal Neuralgia

Intervention / Treatment
-----------------
* Drug: Minocycline


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minocycline<br> | Drug: Minocycline<br>* 200mg bd for 3 days before surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily pain scores on a numerical rating scale |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypo/hyperaesthesia to punctate sensation |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neuropathic pain, Minocycline