The effect of anaesthesia of the phrenic nerve to prevent shoulder pain after major lung surgery.
- Conditions
- Postoperative shoulder pain, after lobectomy and pneumonectomyMedDRA version: 14.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsMedDRA version: 14.1Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2012-002844-25-DK
- Lead Sponsor
- Palle Toft
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Patients planned for elective lobectomy or pneumonectomy.
2. 18 years or more on the day of the operation.
3. Danish skills appropriate for fulfilling preoperative questionnaires.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 52
1. Known contralateral paresis of the Phrenic nerve.
2. Allergy to Ropivacaine or NaCl.
3. Preoperative ipsilateral shoulder pain.
4. Infection or eckzema on the ipsilateral neck. Clinical decision.
5. Dementia or similar cerebral condition that makes the subject unable to perform a NRS-score of pain. Determined by clinical evaluation.
6. Pregnancy.
7. Acute porphyria.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Not applicable;Primary end point(s): Number of patients with shoulder pain within 6 hours after the operation.;Timepoint(s) of evaluation of this end point: Retrospektive NRS, 6 hours after the operation.;Main Objective: To test whether blockade of the phrenic nerve can reduce postoperative shoulder pain after lobectomy and pneumonectomy.<br>
- Secondary Outcome Measures
Name Time Method