Clinical trial NCT02173418: The Effect of Phrenic Nerve Blockade on Acute and Chronic Shoulder Pain in Patients for Lobectomy and Pneumonectomy
Official title: The Effect of Phrenic Nerve Blockade on Acute and Chronic Shoulder Pain in Patients for Lobectomy and Pneumonectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Postoperative pain
Acute postoperative pain
Chronic postoperative pain
Shoulder pain
Thoracotomy
Thoracoscopy
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
name: University of Southern Denmark
name: Læge Fritz Karners og hustrus Foundation
name: Overlæge dr. med. Edgar Schnohr og hustru Gilberte Schnohrs Foundation
First posted: 2014-06-25
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

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

Primary outcomes:
measure: Shoulder pain within 6 hours after the operation
timeFrame: Retrospective numerical rating scale, 6 hours after the operation
Secondary outcomes:
measure: Number of patients with shoulder pain during the first 3 postoperative days.
timeFrame: Postoperative days 0-3
measure: NRS for shoulder pain during the first 3 postoperative days.
timeFrame: Postoperative days 0-3
measure: Opioid use during the first 3 postoperative days
timeFrame: Postoperative day 0-3
measure: Time spent in the recovery room
timeFrame: Measured at discharge from the recovery room. Estimated to be on postoperative day 0 or 1.
measure: Shoulder pain 3 months postoperatively
timeFrame: 3 months postoperatively
measure: NRS for shoulder pain 3 months postoperatively
timeFrame: 3 months postoperatively
measure: Thoracic pain 3 months postoperatively
timeFrame: 3 months postoperatively
measure: NRS for thoracic pain 3 months postoperatively
timeFrame: 3 months postoperatively
measure: opioid use 3 months postoperatively
timeFrame: 3 months postoperatively
measure: Shoulder function 3 months postoperatively
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Departement of Anaesthesia and intensive care, Odense University Hospital
state: Region of Southern Denmark
Study officials:
affiliation: Departement of anaesthesia and intensive care, Odense University Hospital, Odense, Denmark
name: Morten R Blichfeldt-Eckhardt, MD
role: PRINCIPAL_INVESTIGATOR
References: