Minocycline for the Prevention of Post-operative Intercostal Neuralgia

University of Adelaide

Status and phase

Unknown

Phase 2

Conditions

Post-operative Intercostal Neuralgia

Treatments

Drug: Minocycline

Study type

Interventional

Funder types

Other

Identifiers

NCT01314482

U1111-1119-6985

Details and patient eligibility

About

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.

Full 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.

Enrollment

116 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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