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Clinical Trials/EUCTR2020-003300-14-DK
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.

Registry
who.int
Start Date
August 14, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Department of Cardiothoracic Surgery, Aalborg Universityhospital

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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