The Effect of Phrenic Nerve Blockade on Acute and Chronic Shoulder Pain in Patients for Lobectomy and Pneumonectomy

Postoperative Pain Clinical Trial

— TOPBLOC  

Official title:

The Effect of Phrenic Nerve Blockade on Acute and Chronic Shoulder Pain in Patients for Lobectomy and Pneumonectomy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02173418
• Other study ID #: 2012-002844-25
• Secondary ID: S-201201292012-0
• Status: Completed
• Phase: Phase 4
• First received: June 18, 2014
• Last updated: August 16, 2016
• Start date: November 2012
• Est. completion date: July 2014

Study information

• Verified date: August 2016
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection AgencyDenmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to test whether peroperative infiltration of the phrenic nerve during lung surgery would protect patients against postoperative shoulder pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

1. Known contralateral paresis of the Phrenic nerve

2. Allergy to Ropivacaine or Sodium Chloride

3. Preoperative ipsilateral shoulder pain

4. Infection or eczema on the intervention site. 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Shoulder Pain

Intervention

Drug:
• Phrenic nerve block with Ropivacaine

• Phrenic nerve block with saline

Locations

Country	Name	City	State
Denmark	Departement of Anaesthesia and intensive care, Odense University Hospital	Odense	Region of Southern Denmark

Sponsors (5)

Lead Sponsor	Collaborator
Odense University Hospital	Læge Fritz Karners og hustrus Foundation, Overlæge dr. med. Edgar Schnohr og hustru Gilberte Schnohrs Foundation, Region of Southern Denmark, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder pain within 6 hours after the operation	Shoulder pain 6 hours after the operations. Number of patients and numeric rating scale score (0-10)	Retrospective numerical rating scale, 6 hours after the operation	No
Secondary	Number of patients with shoulder pain during the first 3 postoperative days.		Postoperative days 0-3	No
Secondary	NRS for shoulder pain during the first 3 postoperative days.	NRS=numerical rating scale score 0-10	Postoperative days 0-3	No
Secondary	Opioid use during the first 3 postoperative days	Morphine equivalents	Postoperative day 0-3	No
Secondary	Time spent in the recovery room		Measured at discharge from the recovery room. Estimated to be on postoperative day 0 or 1.	No
Secondary	Shoulder pain 3 months postoperatively		3 months postoperatively	No
Secondary	NRS for shoulder pain 3 months postoperatively	NRS=numerical rating scale 0-10	3 months postoperatively	No
Secondary	Thoracic pain 3 months postoperatively		3 months postoperatively	No
Secondary	NRS for thoracic pain 3 months postoperatively	NRS=numerical rating scale 0-10	3 months postoperatively	No
Secondary	opioid use 3 months postoperatively		3 months postoperatively	No
Secondary	Shoulder function 3 months postoperatively	Measured by DASH-score before the operation and after 3 months	3 months postoperatively	No