NCT04726280

Brief Summary

The hypothesis of this study is that a reduced extrafascial volume of local anesthetic for an interscalene brachial plexus block is associated with a lower incidence of diaphragmatic hemiparalysis after an arthroscopic surgery of the shoulder, without any reduction of the analgesic efficacy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2021

Typical duration for phase_4

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

First Submitted

Initial submission to the registry

January 22, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2023

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

2.8 years

First QC Date

January 22, 2021

Last Update Submit

November 20, 2023

Conditions

Arthroscopic Surgery of the ShoulderExtrafascial Interscalene Plexus Brachial Block

Outcome Measures

Primary Outcomes (1)

  • Incidence of hemidiaphragmatic paralysis

    30 minutes after the interscalene plexus brachial extrafascial injection

Secondary Outcomes (19)

  • Incidence of hemidiaphragmatic paralysis

    at 2 and 24 postoperative hours

  • Presence of Dyspnea

    in phase 1 recovery and at 12 and 24 postoperative

  • Presence of PONV

    in phase 1 recovery and at 12 and 24 postoperative

  • Presence of Pruritus

    in phase 1 recovery and at 12 and 24 postoperative hours

  • Presence of Claude-Bernard-Horner syndrome

    in phase 1 recovery and at 12 and 24 postoperative hours

  • +14 more secondary outcomes

Study Arms (2)

10 ml single-shot injection

EXPERIMENTAL

In the 10ml group, participants will have an interscalene brachial plexus with an extrafascial injection of 10 ml ropivacaine 0.75% at the level of C5-C6 nerves roots. Participants will also receive multimodal analgesia with injection of dexamethasone 8 mg iv, magnesium sulfate 40 mg kg\^-1 iv, ketorolac 30 mg iv, and acetaminophen 1000 mg iv, according to the current practice in our institution.

Drug: Ropivacaine 0.75% Injectable Solution

20 ml single-shot injection group

ACTIVE COMPARATOR

In the 20ml group, participants will have an interscalene brachial plexus with an extrafascial injection of 20 ml ropivacaine 0.75% at the level of C5-C6 nerves roots. Participants will also receive multimodal analgesia with injection of dexamethasone 8 mg iv, magnesium sulfate 40 mg kg\^-1 iv, ketorolac 30 mg iv, and acetaminophen 1000 mg iv, according to the current practice in our institution.

Drug: Ropivacaine 0.75% Injectable Solution

Interventions

Ropivacaine 0.75% Injectable SolutionDRUG

10 ml extrafascial interscalene brachial plexus block

10 ml single-shot injection

Eligibility Criteria

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

You may qualify if:

  • arthroscopic surgery of the shoulder
  • ASA class 1 to 3
  • age more than 18 years old

You may not qualify if:

  • patient refusal or inability to understand and/or sign the inform consent
  • contraindication for perineural block (allergy to local anesthetics, infection of puncture site, major coagulopathy, sensitive or motor deficiency on the operative side arm
  • chronic alcool abuse
  • opioid drug abuse or under substitution treatment
  • patients known for allergies to paracetamol, non steroidal anti inflammatory drugs, dexamethasone, sulfate magnesium, ondansetron, droperidol, and omeprazole;
  • patients under chronic corticotherapy
  • patients known for malignant hyperthermia;
  • patients with chronic kidney failure (Glomerular Filtration Rate \< 20 ml/min)
  • patients with severe pulmonary disease
  • patients with history of neck surgery or radiotherapy on the operative side;
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUV (Centre Hospitalier Universitaire Vaudois)

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

  • Renard Y, Grape S, Gonvers E, Rossel JB, Goetti P, Albrecht E. Respiratory impact of local anaesthetic volume after interscalene brachial plexus block with extrafascial injection: a randomised controlled double-blinded trial. Br J Anaesth. 2025 Apr;134(4):1153-1160. doi: 10.1016/j.bja.2024.12.010. Epub 2025 Jan 23.

    PMID: 39855930DERIVED

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

January 22, 2021

First Posted

January 27, 2021

Study Start

February 1, 2021

Primary Completion

November 20, 2023

Study Completion

November 20, 2023

Last Updated

November 21, 2023

Record last verified: 2023-11

Locations

CH(1)