NCT02576223

Brief Summary

The purpose of this randomized study is to examine the effect of a selective suprascapular nerve block on post operative pain after arthroscopic shoulder surgery. Half of the subjects will receive a active nerve block with Ropivacain. Half of the subjects will receive a placebo nerve block with saline.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable pain

Geographic Reach
1 country

2 active sites

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

October 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 15, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2018

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

2.9 years

First QC Date

October 13, 2015

Last Update Submit

March 20, 2024

Conditions

Pain

Keywords

Peripheral Nerve Blocks

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale (VAS) score at rest at T½

    Change in VAS score at rest from baseline to 30 minutes after nerve block (T½).

    Baseline to 30 minutes

Secondary Outcomes (5)

  • VAS score during maximum active shoulder abduction from T½ to T6

    ½, 1, 2, 3, 4, 5, 6 hours

  • VAS score at rest from T½ to T6

    ½, 1, 2, 3, 4, 5, 6 hours

  • Morphine consumption.

    6 hours

  • Electromyography at T½

    Baseline to 30 minutes

  • Muscle strength at T½

    Baseline to 30 minutes

Study Arms (2)

Ropivacaine hydrochloride

ACTIVE COMPARATOR

Ropivacain 7.5mg/ml, 5 ml injected perineural at the suprascapular nerve.

Drug: Ropivacaine hydrochlorideDrug: PCA-pump

Isotonic Saline

PLACEBO COMPARATOR

0.9% Saline solution, 5 ml injected perineural at the suprascapular nerve.

Drug: Isotonic SalineDrug: PCA-pump

Interventions

Ropivacaine hydrochlorideDRUG

Ropivacaine injected perineural at the suprascapular nerve.

Also known as: Ropivacaine, Naropin
Ropivacaine hydrochloride
Isotonic SalineDRUG

Saline injected perineural at the suprascapular nerve.

Also known as: Saline
Isotonic Saline
PCA-pumpDRUG

PCA (Patient controlled analgesia) pump with the following settings: Age \> 70 years or weight \< 60 kg: bolus dose 2,5 mg i.v. morphine, 15 minutes lockout Age \< 70 years and weight \> 60 kg: bolus dose 5 mg i.v. morphine, 15 minutes lockout Lockout time 15 minutes.

Also known as: Morphine
Isotonic SalineRopivacaine hydrochloride

Eligibility Criteria

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

You may qualify if:

  • Patients planned for arthroscopic shoulder surgery.
  • Age ≥ 18.
  • ASA class ≤ 3.

You may not qualify if:

  • Patients with VAS never ≥5 mm during the first hour after arrivel to the post anesthesia care unit.
  • Patients unable to cooperate.
  • Patients unable to understand or speak danish.
  • Allergy towards the used drugs.
  • Abuse of alcohol- and/or medicine - investigators assessment.
  • Usage of opioids on a daily basis (not including Tramadole).
  • Pregnancy (It is obligatory for all fertile women in the study to take a hcg urine test).
  • Operations involving the clavicle.
  • Operations converted to open surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nordsjællands Hospital

Hillerød, 3400, Denmark

Location

Holbæk Sygehus

Holbæk, 4300, Denmark

Location

MeSH Terms

Conditions

Pain

Interventions

RopivacaineSodium ChlorideMorphine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Christian Steen-Hansen

    Nordsjaellands Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Research

Study Record Dates

First Submitted

October 13, 2015

First Posted

October 15, 2015

Study Start

October 1, 2015

Primary Completion

August 27, 2018

Study Completion

August 27, 2018

Last Updated

March 21, 2024

Record last verified: 2024-03

Locations

DK(2)