NCT02173418

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for phase_4 postoperative-pain

Timeline
Completed

Started Nov 2012

Typical duration for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 25, 2014

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

1.7 years

First QC Date

June 18, 2014

Last Update Submit

August 16, 2016

Conditions

Postoperative Pain

Keywords

Postoperative painAcute postoperative painChronic postoperative painShoulder painThoracotomyThoracoscopy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • 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.

    Postoperative days 0-3

  • Opioid use during the first 3 postoperative days

    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

  • +5 more secondary outcomes

Study Arms (2)

Ropivacaine

EXPERIMENTAL

Phrenic nerve block with Ropivacaine

Drug: Phrenic nerve block with Ropivacaine

Placebo

PLACEBO COMPARATOR

Phrenic nerve block with Sodium chloride

Drug: Phrenic nerve block with saline

Interventions

Phrenic nerve block with RopivacaineDRUG
Also known as: Naropin
Ropivacaine
Phrenic nerve block with salineDRUG
Also known as: Sodium Chloride
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients planned for elective lobectomy or pneumonectomy
  • years or more on the day of the operation
  • Danish skills appropriate for fulfilling preoperative questionnaires

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of Anaesthesia and intensive care, Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

Location

MeSH Terms

Conditions

Pain, PostoperativeShoulder Pain

Interventions

RopivacaineSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsArthralgiaJoint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Morten R Blichfeldt-Eckhardt, MD

    Departement of anaesthesia and intensive care, Odense University Hospital, Odense, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Afdelingslæge

Study Record Dates

First Submitted

June 18, 2014

First Posted

June 25, 2014

Study Start

November 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 17, 2016

Record last verified: 2016-08

Locations

DK(1)