Suprascapular Nerve Block as Postoperative Analgesia After Artroscopic Shoulder Surgery

March 20, 2024 updated by: Kai Henrik Wiborg Lange

Suprascapular Nerve Block as Postoperative Analgesia After Artroscopic Shoulder Surgery - a Randomized, Blinded, Placebo Controlled Study

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.

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.

Detailed Description

Postoperative pain management after arthroscopic shoulder surgery traditionally includes opioids and/or an interscalene brachial plexus block(IBPB). Opioid consumption often leads to unpleasant side effects including nausea, vomitting and sedation. IBPB offers very efficient pain relief but includes the discomfort of a paralyzed arm. Furthermore this approach often also leads to unilateral paresis of the phrenic nerve causing reduced respiratory capacity. The latter offering discomfort and a potential risk in patients with lung diseases or heavy overweight.

The suprascapular nerve is the most important nerve to the shoulder and a selective block of this nerve could offer a good pain relief without the mentioned side effects.

In this randomized study the investigators wish to examine the pain relieving effect of a selective block of the suprascapular nerve after arthroscopic shoulder surgery.

40 patients are randomized to a block of this nerve with either active drug (Ropivacaine) or placebo (Saline). All patients will get a PCA (Patient Controlled Analgesia) pump for administration of i.v. morphine in doses based on age and weight.

Patient are being monitored for 6 hours. The primary outcome is reduction in VAS at rest from baseline to 30 minutes after nerve block.

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.
40

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.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
      • Hillerød, Denmark, 3400
        • Nordsjællands Hospital
      • Holbæk, Denmark, 4300
        • Holbæk Sygehus

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

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.
Active Comparator: Ropivacaine hydrochloride
Ropivacain 7.5mg/ml, 5 ml injected perineural at the suprascapular nerve.
Drug: Ropivacaine hydrochloride
Ropivacaine injected perineural at the suprascapular nerve.
Other Names:
  • Ropivacaine, Naropin
Drug: PCA-pump

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.

Other Names:
  • Morphine
Placebo Comparator: Isotonic Saline
0.9% Saline solution, 5 ml injected perineural at the suprascapular nerve.
Drug: Isotonic Saline
Saline injected perineural at the suprascapular nerve.
Other Names:
  • Saline
Drug: PCA-pump

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.

Other Names:
  • Morphine

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
Measure Description
Time Frame
Visual analogue scale (VAS) score at rest at T½
Time Frame: Baseline to 30 minutes
Change in VAS score at rest from baseline to 30 minutes after nerve block (T½).
Baseline to 30 minutes

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
Morphine consumption.
Time Frame: 6 hours
The total amount of morphine administered via the intravenous PCA pump the first 6 hours after nerve block.
6 hours
VAS score during maximum active shoulder abduction from T½ to T6
Time Frame: ½, 1, 2, 3, 4, 5, 6 hours
VAS scores measured at 7 timepoints (T½, T1, T2, T3, T4, T5, T6) during maximal active shoulder abduction and calculated as area under the curve (AUC).
½, 1, 2, 3, 4, 5, 6 hours
VAS score at rest from T½ to T6
Time Frame: ½, 1, 2, 3, 4, 5, 6 hours
VAS scores measured at 7 timepoints (T½, T1, T2, T3, T4, T5, T6) at rest and calculated as area under the curve (AUC).
½, 1, 2, 3, 4, 5, 6 hours
Electromyography at T½
Time Frame: Baseline to 30 minutes
Change in activity of the infraspinatus muscle measured with surface electromyography from baseline to T½.
Baseline to 30 minutes
Muscle strength at T½
Time Frame: Baseline to 30 minutes
Change in strength of the supraspinatus (abduction of the shoulder) and the infraspinatus muscle (external rotation of the shoulder) measured with a handheld dynamometer from baseline to T½.
Baseline to 30 minutes

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.
Kai Henrik Wiborg Lange

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.
  • Principal Investigator: Christian Steen-Hansen, Nordsjællands Hospital

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.
October 1, 2015

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.
August 27, 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.
August 27, 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).
October 13, 2015

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.
October 14, 2015

First Posted (Estimated)

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.
October 15, 2015

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.
March 21, 2024

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.
March 20, 2024

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.
March 1, 2024

More Information

Terms related to this study

Keywords

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.
  • H-15008712
  • 2015-002391-24 (EudraCT Number)

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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