Postoperative Pain
Conditions
Keywords
Postoperative pain, Acute postoperative pain, Chronic postoperative pain, Shoulder pain, Thoracotomy, Thoracoscopy
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.
Interventions
DRUGPhrenic nerve block with Ropivacaine
DRUGPhrenic nerve block with saline
Sponsors
Region of Southern Denmark
University of Southern Denmark
Læge Fritz Karners og hustrus Foundation
Overlæge dr. med. Edgar Schnohr og hustru Gilberte Schnohrs Foundation
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Number of patients with shoulder pain during the first 3 postoperative days. | Postoperative days 0-3 | — |
| 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 |
| NRS for shoulder pain 3 months postoperatively | 3 months postoperatively | NRS=numerical rating scale 0-10 |
Countries
Denmark
Outcome results
None listed