NCT02903719

Brief Summary

The aim of this study is to explore whether the use of ultrasound guided phrenic nerve block can reduce the postoperative pain in the shoulder after liver resection. The intervention is directed postoperative to the patients experiencing novel right sided shoulder pain.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

7 months

First QC Date

September 13, 2016

Last Update Submit

September 22, 2016

Conditions

Shoulder PainSurgeryNerve Block

Keywords

PhrenicNerve blockPostoperative shoulder painLiver resection

Outcome Measures

Primary Outcomes (1)

  • Pain measurements on a NRS (Numeric Rating Scale)

    Patients are asked to rate the intensity of their shoulder pain (if any) according to NRS (Numeric Rating Scale) from 0-10 (0=no pain, 10=the worst pain imaginable). For patients receiving the intervention they are asked to rate the intensity of their pain 15 minutes after the 1st intervention.

    1 hour

Secondary Outcomes (9)

  • Lung function assessed by Spirometry

    1 day

  • Lung function assessed by arterial blood gas

    1 hour

  • Duration of surgery compared to shoulder pain

    1 hour

  • Number of included patients with low pain score (NRS) after interventions.

    1 hour and 15 minutes

  • Number of patients with respiratory affection

    1 day

  • +4 more secondary outcomes

Study Arms (2)

Group A

OTHER

1. st intervention: A single ultrasound guided perineural injection of Ropivacaine 7,5 mg/ml, 3 ml 2. nd intervention (approx. 15 minutes after 1st intervention): A single ultrasound guided perineural injection of isotonic saline solution 9 mg/ml, 3 ml

Drug: Ropivacaine

Group B

OTHER

1. st Intervention: A single ultrasound guided perineural injection of isotonic saline solution 9 mg/ml, 3 ml 2. nd Intervention (approx. 15 minutes after 1st intervention):A single ultrasound guided perineural injection of Ropivacaine 7,5 mg/ml, 3 ml

Drug: Ropivacaine

Interventions

RopivacaineDRUG

All included patients with a right sided shoulder pain score on a numeric rating scale (NRS) equal to or above 6 and without postoperative exclusion criteria will have two (1st and 2nd intervention) ultrasound guided phrenic nerve blocks performed.

Also known as: Naropin
Group AGroup B

Eligibility Criteria

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

You may qualify if:

  • Age above 18.
  • Patients scheduled for liver resection.
  • Ability to give informed consent.

You may not qualify if:

  • Participation in another clinical trial, dealing with pain or management of pain, which could affect this trial, evaluated by the investigator.
  • Inability to talk and understand danish
  • Drug or alcohol abuse
  • Pregnancy
  • Congestive heart failure (NYHA class III-IV), or other serious heart disease.
  • Chronic obstructive lung disease, moderate or severe degree, or other significant lung disease
  • Chronic or acute shoulder pain prior to surgery.
  • Body Mass Index above 35.
  • Infection at the site of the injection
  • Allergy to ropivacaine
  • Postoperative:
  • Shoulder pain score \< 6 assessed on the numeric rating scale (0-10), 15 minutes after arrival in postanaesthetic care unit (PA CU).
  • Insufficient epidural analgesia, or lack of epidural analgesia.
  • Inability to visualize nervus phrenicus with sonography.
  • Cerebral confusion, postoperative delirium or other medical condition hindering study intervention.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2200, Denmark

RECRUITING

MeSH Terms

Conditions

Shoulder Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Søren Mr Bøgevig, MD

CONTACT

0045 20 66 40 51soeren.boegevig.03@regionh.dk

Eske mr Aasvang, MD, PhD

CONTACT

0045 26 23 20 76eske.aas@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 13, 2016

First Posted

September 16, 2016

Study Start

September 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

September 23, 2016

Record last verified: 2016-09

Locations

DK(1)