Clinical trial NCT01314482: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Post-operative Intercostal Neuralgia
Keywords: Neuropathic pain
Minocycline
Lead sponsor: University of Adelaide
Sponsor class: OTHER
First posted: 2011-03-14
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Daily pain scores on a numerical rating scale
timeFrame: 3 months
Secondary outcomes:
measure: Hypo/hyperaesthesia to punctate sensation
timeFrame: 3 months
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
Study officials:
References: