Post-operative Intercostal Neuralgia Clinical Trial
Official title:
The Efficacy of Prophylactic Administration of Minocycline in Reducing Chronic Intercostal Neuralgia Post-thoracotomy
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.
| Status | Recruiting |
| Enrollment | 116 |
| Est. completion date | February 2014 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Royal Adelaide Hospital | Adelaide | South Australia |
| Lead Sponsor | Collaborator |
|---|---|
| University of Adelaide |
Australia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Daily pain scores on a numerical rating scale | 3 months | No | |
| Secondary | Hypo/hyperaesthesia to punctate sensation | 3 months | No |