Minocycline for the Prevention of Post-operative Intercostal Neuralgia

• Status: Unknown status
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Adelaide
• Treatments: Minocycline

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