Minocycline for the Prevention of Post-operative Intercostal Neuralgia

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.

Study Overview

• Status: Unknown
• Conditions: Post-operative Intercostal Neuralgia
• Intervention / Treatment: Drug: Minocycline

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.

• Study Type: Interventional
• Enrollment (Anticipated): 116
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Recruiting
      • Royal Adelaide Hospital
      • Contact: Melanie Gentgall, RN; Phone Number: +61 8 82222712; Email: melanie.gentgall@health.sa.gov.au
      • Contact: James Swift, BHlthSci(Hons); Phone Number: +61 8 82222712; Email: james.swift@adelaide.edu.au
      • Principal Investigator: Craig Jurisevic, MD
      • Sub-Investigator: Paul E Rolan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Minocycline	Drug: Minocycline; 200mg bd for 3 days before surgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Adelaide

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): February 1, 2014

Study Registration Dates

• First Submitted: March 11, 2011
• First Submitted That Met QC Criteria: March 11, 2011
• First Posted (Estimate): March 14, 2011

Study Record Updates

• Last Update Posted (Estimate): February 6, 2013
• Last Update Submitted That Met QC Criteria: February 4, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Neuropathic pain; Minocycline
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Anti-Infective Agents; Anti-Bacterial Agents; Minocycline
• Other Study ID Numbers: U1111-1119-6985