Prospective Observational Study on the Analgesic Effectiveness of Blocking the Suprascapular and Axillary Nerves in Shoulder Arthroscopy.

September 24, 2024 updated by: Jose Manuel López González

Prospective Observational Study on the Analgesic Effectiveness of Blocking the Shoulder´s Anterior Capsule and the Suprascapular Nerve by the Anterior Approach Versus Blocking of the Suprascapular and Axillary Nerves by the Posterior Approach in Shoulder Arthroscopy.

The purpose of this study was to evaluate the analgesic efficacy of suprascapular and axillary nerve block for shoulder arthroscopy surgery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

An observational study of paired cohorts, not randomized, was designed with the aim of comparing the postoperative analgesic effectiveness of two regional analgesic techniques: the shoulder anterior capsular block associated with the suprascapular nerve block performed via an anterior approach versus the suprascapular and axillary nerve blocks performed posteriorly in patients with shoulder surgery via arthroscopy in procedures that cause intense postoperative pain.

Study Type

Observational

Enrollment (Actual)

166

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

  • Spain
    • Asturias
      • Oviedo, Asturias, Spain, 33001
        • FINBA

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

After approval of the study by Galician Drug Research Ethics Committee, Spain (CEIm-G) and obtaining informed consent from the participants, patients undergoing shoulder arthroscopy surgery consecutively over the course of one year were included who met the study inclusion criteria.

Description

Inclusion Criteria:

  • Patients over 18 years of age.
  • ASA (Physical Status Classification System) I - III.
  • Having been scheduled for shoulder arthroscopy surgery.

Exclusion Criteria:

Any contraindication for performing regional anesthetic techniques:

  • Infection at the puncture point.
  • Alteration of hemostasis.
  • Allergy to local anesthetics.
  • Patient refusal to participate in the study.
  • Inability to evaluate postoperative pain.
  • Known neuropathy of the operated limb.
  • Patients who required conversion 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SHAC block + anterior SSN block
Group of patients undergoing shoulder arthroscopy who underwent a block of the anterior capsule of the shoulder (SHAC block) with the suprascapular nerve block (SSN block) performed via an anterior approach with 20 ml of 0.20% ropivacaine
Procedure: Shoulder arthroscopy
Shoulder arthroscopy in procedures that cause intense postoperative pain
Posterior SSN + AN blocks
Group of patients undergoing shoulder arthroscopy who underwent a suprascapular and axillary nerve block performed via a posterior approach with 20 ml of 0.20% ropivacaine
Procedure: Shoulder arthroscopy
Shoulder arthroscopy in procedures that cause intense postoperative pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: The measurement of pain intensity according to the numerical rating scale at preoperative and at the 1st, 2nd, 12th ant 24th postoperative hours
The measurement of pain intensity according to the numerical rating scale (NRS) from 0 (absence of pain) to 10 (maximum pain endured)
The measurement of pain intensity according to the numerical rating scale at preoperative and at the 1st, 2nd, 12th ant 24th postoperative hours

Collaborators and Investigators

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

Sponsor

Jose Manuel López González

Investigators

  • Principal Investigator: Bárbara María Jiménez Gómez, MD, Central University Hospital of Asturias, 33001, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 12, 2023

Primary Completion (Actual)

September 2, 2024

Study Completion (Actual)

September 2, 2024

Study Registration Dates

First Submitted

September 22, 2024

First Submitted That Met QC Criteria

September 22, 2024

First Posted (Actual)

September 25, 2024

Study Record Updates

Last Update Posted (Actual)

September 26, 2024

Last Update Submitted That Met QC Criteria

September 24, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/491

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

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.

Subscribe