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The effect of anaesthesia of the phrenic nerve to prevent shoulder pain after major lung surgery.

The effect of Phrenic nerve blokade on acute and chronic shoulder pain in patients for lobectomy and pneumonectomy. - TOP BLOC

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-002844-25-DK
Enrollment
Unknown
Registered
2012-08-07
Start date
2012-08-13
Completion date
Unknown
Last updated
2015-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative shoulder pain, after lobectomy and pneumonectomy MedDRA version: 14.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 14.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Ropivacaine Pharmaceutical Form: Injection INN or Proposed INN: ROPIVACAINE CAS Number: 84057-95-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration

Sponsors

Palle Toft
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.—

Secondary

MeasureTime frame
Secondary end point(s): 1. Number of patients with shoulder pain within the first 3 postoperative days. 2. NRS for shoulder pain in the first 3 postoperative days. 3. NRS for overall pain in the first 3 postoperative days 4. Opioid us in the first 3 postoperative days . 5. Time on the recovery room. 6. Shoulder pain after 3 months. 7. NRS for sholder pain after 3 months. 8. Thoracic pain after 3 months. 9. NRS for thoracic pain after 3 months. 10. Opioid use after 3 months. 11. Shoulderfunction after 3 months. ;Timepoint(s) of evaluation of this end point: 1. 3 days after the operation. 2. Retrospective NRS 3 times a day, day 0-3 after the operation. 3. Retrospective NRS 3 times a day, day 0-3 after the operation. 4. Cumulated opiod use, day 0-3 after the operation. 5. Time at discharge from the recovery room. 6. 3 months after the operation. 7. 3 months after the operation. 8. 3 months after the operation. 9. 3 months after the operation. 10. 3 months after the operation. 11. 3 months after the operation.—

Countries

Denmark

Contacts

Public ContactMorten Rune Blichfeldt-Eckhardt

Morten Rune Blichfeldt-Eckhardt

morten.rune.blichfeldt-eckhardt@ouh.regionsyddanmark.dk+4565412528

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026