EUCTR2020-003300-14-DK
Active, Not Recruiting
Phase 1
Botulinum Toxin A as Treatment for Chronic Postsurgical Pain Following LungCancer Surgery: a Randomized Controlled Pilot Trial
Department of Cardiothoracic Surgery, Aalborg Universityhospital0 sites30 target enrollmentAugust 14, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Post Thoracotomy Pain Syndrome (PTPS)
- Sponsor
- Department of Cardiothoracic Surgery, Aalborg Universityhospital
- Enrollment
- 30
- Status
- Active, Not Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients of 18 years of age or above.
- •2\. Patients who have undergone pulmonary surgery because of suspicion
- •or confirmed pulmonary malignancies.
- •3\. Patients who are radically treated for pulmonary malignancy
- •4\. Patients who suffers from chronic pain or unpleasant sensations at the site of scar at least six months after surgery with fully healed surgical wounds.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range 10
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •1\. Patients who cannot understand oral and written information.
- •2\. Patients who were not radically operated.
- •3\. Patients with other concomitant or other active cancer diseases.
- •4\. Patients with chronic pain in the chest wall prior to surgery.
- •5\. Pregnant women or women planning to get pregnant in the study period.
- •6\. Patients with autoimmune neuromuscular diseases, sclerosis, peripheral
- •neuromuscular disturbances and general muscle weakness or atrophy.
- •7\. Patients with intolerance or allergy to BOTOX®.
- •8\. Patients who are at present treated with Onabotulinum toxin A or similar neuromuscular blocking drug or have received such in the past year.
Outcomes
Primary Outcomes
Not specified
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