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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Phrenic nerve block with Ropivacaine
Phrenic nerve block with saline
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative pain, Acute postoperative pain, Chronic postoperative pain, Shoulder pain, Thoracotomy, Thoracoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Departement of Anaesthesia and intensive care, Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ropivacaine

Placebo

Arm Description

Phrenic nerve block with Ropivacaine

Phrenic nerve block with Sodium chloride

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Number of patients with shoulder pain during the first 3 postoperative days.
NRS for shoulder pain during the first 3 postoperative days.
NRS=numerical rating scale score 0-10
Opioid use during the first 3 postoperative days
Morphine equivalents
Time spent in the recovery room
Shoulder pain 3 months postoperatively
NRS for shoulder pain 3 months postoperatively
NRS=numerical rating scale 0-10
Thoracic pain 3 months postoperatively
NRS for thoracic pain 3 months postoperatively
NRS=numerical rating scale 0-10
opioid use 3 months postoperatively
Shoulder function 3 months postoperatively
Measured by DASH-score before the operation and after 3 months

Full Information

First Posted
June 18, 2014
Last Updated
August 16, 2016
Sponsor
Odense University Hospital
Collaborators
Region of Southern Denmark, University of Southern Denmark, Læge Fritz Karners og hustrus Foundation, Overlæge dr. med. Edgar Schnohr og hustru Gilberte Schnohrs Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02173418
Brief Title
The Effect of Phrenic Nerve Blockade on Acute and Chronic Shoulder Pain in Patients for Lobectomy and Pneumonectomy
Acronym
TOPBLOC
Official Title
The Effect of Phrenic Nerve Blockade on Acute and Chronic Shoulder Pain in Patients for Lobectomy and Pneumonectomy.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
Region of Southern Denmark, University of Southern Denmark, Læge Fritz Karners og hustrus Foundation, Overlæge dr. med. Edgar Schnohr og hustru Gilberte Schnohrs Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Postoperative pain, Acute postoperative pain, Chronic postoperative pain, Shoulder pain, Thoracotomy, Thoracoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine
Arm Type
Experimental
Arm Description
Phrenic nerve block with Ropivacaine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Phrenic nerve block with Sodium chloride
Intervention Type
Drug
Intervention Name(s)
Phrenic nerve block with Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Type
Drug
Intervention Name(s)
Phrenic nerve block with saline
Other Intervention Name(s)
Sodium Chloride
Primary Outcome Measure Information:
Title
Shoulder pain within 6 hours after the operation
Description
Shoulder pain 6 hours after the operations. Number of patients and numeric rating scale score (0-10)
Time Frame
Retrospective numerical rating scale, 6 hours after the operation
Secondary Outcome Measure Information:
Title
Number of patients with shoulder pain during the first 3 postoperative days.
Time Frame
Postoperative days 0-3
Title
NRS for shoulder pain during the first 3 postoperative days.
Description
NRS=numerical rating scale score 0-10
Time Frame
Postoperative days 0-3
Title
Opioid use during the first 3 postoperative days
Description
Morphine equivalents
Time Frame
Postoperative day 0-3
Title
Time spent in the recovery room
Time Frame
Measured at discharge from the recovery room. Estimated to be on postoperative day 0 or 1.
Title
Shoulder pain 3 months postoperatively
Time Frame
3 months postoperatively
Title
NRS for shoulder pain 3 months postoperatively
Description
NRS=numerical rating scale 0-10
Time Frame
3 months postoperatively
Title
Thoracic pain 3 months postoperatively
Time Frame
3 months postoperatively
Title
NRS for thoracic pain 3 months postoperatively
Description
NRS=numerical rating scale 0-10
Time Frame
3 months postoperatively
Title
opioid use 3 months postoperatively
Time Frame
3 months postoperatively
Title
Shoulder function 3 months postoperatively
Description
Measured by DASH-score before the operation and after 3 months
Time Frame
3 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morten R Blichfeldt-Eckhardt, MD
Organizational Affiliation
Departement of anaesthesia and intensive care, Odense University Hospital, Odense, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departement of Anaesthesia and intensive care, Odense University Hospital
City
Odense
State/Province
Region of Southern Denmark
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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