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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Phrenic nerve block with Ropivacaine; Drug: Phrenic nerve block with saline

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Region of Southern Denmark
    • Odense, Region of Southern Denmark, Denmark, 5000
      • Departement of Anaesthesia and intensive care, Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ropivacaine; Phrenic nerve block with Ropivacaine	Drug: Phrenic nerve block with Ropivacaine; Other Names: Naropin
PLACEBO_COMPARATOR: Placebo; Phrenic nerve block with Sodium chloride	Drug: Phrenic nerve block with saline; 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

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: University of Southern Denmark; Region of Southern Denmark; Læge Fritz Karners og hustrus Foundation; Overlæge dr. med. Edgar Schnohr og hustru Gilberte Schnohrs Foundation
• Investigators: Principal Investigator: Morten R Blichfeldt-Eckhardt, MD, Departement of anaesthesia and intensive care, Odense University Hospital, Odense, Denmark

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ACTUAL): July 1, 2014
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: June 18, 2014
• First Submitted That Met QC Criteria: June 23, 2014
• First Posted (ESTIMATE): June 25, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): August 17, 2016
• Last Update Submitted That Met QC Criteria: August 16, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Thoracotomy; Thoracoscopy; Postoperative pain; Acute postoperative pain; Chronic postoperative pain; Shoulder pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Pain, Postoperative; Shoulder Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 2012-002844-25 (EUDRACT_NUMBER); S-20120129 (OTHER: Regional ethics committee)