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

Study Overview
=================
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.

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

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Phrenic nerve block with Ropivacaine
* Drug: Phrenic nerve block with saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients planned for elective lobectomy or pneumonectomy 18 years or more on the day of the operation Danish skills appropriate for fulfilling preoperative questionnaires Exclusion Criteria: Known contralateral paresis of the Phrenic nerve Allergy to Ropivacaine or Sodium Chloride Preoperative ipsilateral shoulder pain Infection or eczema on the intervention site. Clinical decision Dementia or similar cerebral condition that makes the subject unable to perform a NRS-score of pain. Determined by clinical evaluation Pregnancy Acute porphyria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine<br>Phrenic nerve block with Ropivacaine | Drug: Phrenic nerve block with Ropivacaine<br> <br> * Other names: Naropin;|
| Placebo Comparator: Placebo<br>Phrenic nerve block with Sodium chloride | Drug: Phrenic nerve block with saline<br> <br> * Other names: Sodium Chloride;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | NRS=numerical rating scale score 0-10 | Postoperative days 0-3 | 
| Opioid use during the first 3 postoperative days | Morphine equivalents | Postoperative day 0-3 | 
| 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 | NRS=numerical rating scale 0-10 | 3 months postoperatively | 
| Thoracic pain 3 months postoperatively |  | 3 months postoperatively | 
| NRS for thoracic pain 3 months postoperatively | NRS=numerical rating scale 0-10 | 3 months postoperatively | 
| opioid use 3 months postoperatively |  | 3 months postoperatively | 
| Shoulder function 3 months postoperatively | Measured by DASH-score before the operation and after 3 months | 3 months postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative pain, Acute postoperative pain, Chronic postoperative pain, Shoulder pain, Thoracotomy, Thoracoscopy