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

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Phrenic nerve block with saline; Drug: Phrenic nerve block with Ropivacaine

• Registration Number: NCT02173418
• Lead Sponsor: Odense University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2014-06-18
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-25
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Phrenic nerve block with saline	Phrenic nerve block with Sodium chloride
Ropivacaine	Phrenic nerve block with Ropivacaine	Phrenic nerve block with Ropivacaine

Primary Outcome Measures

Name	Time	Method
Shoulder pain within 6 hours after the operation	Retrospective numerical rating scale, 6 hours after the operation	Shoulder pain 6 hours after the operations. Number of patients and numeric rating scale score (0-10)

Secondary Outcome Measures

Name	Time	Method
Number of patients with shoulder pain during the first 3 postoperative days.	Postoperative days 0-3
NRS for shoulder pain during the first 3 postoperative days.	Postoperative days 0-3	NRS=numerical rating scale score 0-10
Opioid use during the first 3 postoperative days	Postoperative day 0-3	Morphine equivalents
Time spent in the recovery room	Measured at discharge from the recovery room. Estimated to be on postoperative day 0 or 1.
Shoulder pain 3 months postoperatively	3 months postoperatively
NRS for shoulder pain 3 months postoperatively	3 months postoperatively	NRS=numerical rating scale 0-10
Thoracic pain 3 months postoperatively	3 months postoperatively
NRS for thoracic pain 3 months postoperatively	3 months postoperatively	NRS=numerical rating scale 0-10
opioid use 3 months postoperatively	3 months postoperatively
Shoulder function 3 months postoperatively	3 months postoperatively	Measured by DASH-score before the operation and after 3 months

Trial Locations

Locations (1)

Departement of Anaesthesia and intensive care, Odense University Hospital; 🇩🇰 Odense, Region of Southern Denmark, Denmark