Dexamethasone as an Adjuvant to Ropivacaine for the Interscalene Brachial Plexus Block

January 6, 2020 updated by: Eric Albrecht, Centre Hospitalier Universitaire Vaudois

Dexamethasone as an Adjuvant to Ropivacaine for the Interscalene Brachial Plexus Block: a Dose-finding Study

Shoulder surgery is associated with moderate to severe postoperative pain. Interscalene brachial plexus block is considered by many as the gold standard for treating postoperative pain and consists of injecting local anaesthetics close to the nerves of the brachial plexus in the neck. Duration of analgesia is between eight to twelve hours depending on the type of administered drugs. Dexamethasone 4 mg is a steroid routinely injected intravenously in anaesthesia for the prophylaxis of postoperative nausea and vomiting. Recently, different trials have demonstrated that combining 4 to 8 mg of dexamethasone with local anaesthetics for a perineural injection may prolong the duration of analgesia up to 24 hours. In a meta-analysis including 29 trials and 1695 patients, investigators have recently demonstrated through a meta-regression that a dose of 4 mg is sufficient and represents a ceiling dose, without neurological complications. The objective of this multicenter randomised controlled double-blinded trial is to determine the optimal dose of perineural dexamethasone. For that purpose, investigators will include a total of 150 patients divided in 5 groups: local anaesthetics with placebo, or with dexamethasone 1, 2, 3 and 4 mg.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Kortrijk, Belgium, 8500
        • AZ Groeninge Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients scheduled for elective shoulder arthroscopy
  • duration of surgery less than 4 hours

Exclusion Criteria:

  • allergy to local anaesthetics
  • history of neck surgery
  • history of neck radiotherapy
  • severe respiratory disease
  • diabetic patient
  • chronic pain condition
  • pregnancy
  • patient suffering from cancer
  • patient with addicted disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control group
Patients will receive ropivacaine 0.5% 20 mls with normal saline 0.9% 2 mls
Drug: Placebo
Normal saline 0.9% in 2 mls
Drug: Ropivacaine 0.5%
Ropivacaine 0.5% 20 mls
Active Comparator: Dex 1
Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 1 mg in 2 mls
Drug: Ropivacaine 0.5%
Ropivacaine 0.5% 20 mls
Drug: Dexamethasone 1 mg
Dexamethasone 1 mg in 2 mls
Active Comparator: Dex 2
Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 2 mg in 2 mls
Drug: Ropivacaine 0.5%
Ropivacaine 0.5% 20 mls
Drug: Dexamethasone 2 mg
Dexamethasone 2 mg in 2 mls
Active Comparator: Dex 3
Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 3 mg in 2 mls
Drug: Ropivacaine 0.5%
Ropivacaine 0.5% 20 mls
Drug: Dexamethasone 3 mg
Dexamethasone 3 mg in 2 mls
Active Comparator: Dex 4
Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 4 mg in 2 mls
Drug: Ropivacaine 0.5%
Ropivacaine 0.5% 20 mls
Drug: Dexamethasone 4 mg
Dexamethasone 4 mg in 2 mls

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Duration of analgesia
Time Frame: 24hour
24hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of motor block
Time Frame: 24hour
24hour
Onset time of action of sensory block
Time Frame: 1hour
1hour
Onset time of action of motor block
Time Frame: 1hour
1hour
Equivalent morphine consumption in postanesthetic care unit
Time Frame: 4hour
4hour
Equivalent morphine consumption on postoperative day 1
Time Frame: 24hour
24hour
Pain scores at rest in postanesthetic care unit (visual analogue scale, 0-10)
Time Frame: 4hour
4hour
Pain scores on movement in postanesthetic care unit (visual analogue scale, 0-10)
Time Frame: 4hour
4hour
Pain scores at rest on postoperative day 1 (visual analogue scale, 0-10)
Time Frame: 24hour
24hour
Pain scores on movement on postoperative day 1 (visual analogue scale, 0-10)
Time Frame: 24hour
24hour
Rate of postoperative nausea and vomiting (PONV)
Time Frame: 24hour
Presence of PONV (YES/NO)
24hour
Rate of pruritus
Time Frame: 24hour
Presence of pruritus (YES/NO)
24hour
Satisfaction score on postoperative day 1 (visual analogue scale, 0-10)
Time Frame: 24hour
24hour
Glycemia in postanesthetic care unit (mmol/l)
Time Frame: 4hour
4hour
Rate of infection
Time Frame: 24hour
Presence of infection (YES/NO)
24hour
Rate of infection
Time Frame: 7 days
Presence of infection (YES/NO)
7 days
Rate of paresthesia
Time Frame: 7 days
Presence of paresthesia (YES/NO)
7 days
Rate of muscle weakness
Time Frame: 7 days
Presence of muscle weakness (YES/NO)
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire Vaudois

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Eric Albrecht, MD, Centre Hospitalier Universitaire Vaudois
  • Principal Investigator: Matthias Matthias, MD, AZ Groeninge Hospital, Pres. Kennedylaan 4, 8500 Kortrijk, Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CER 217/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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