Effect of Interscalene and Suprascapular Nerve Block on Analgesia Consumption After Adhesive Capsulitis Surgery

July 28, 2022 updated by: Sibel Seçkin Pehlivan, TC Erciyes University
In this study, a combination of different types of blocks for adhesive capsulitis surgery, the investigators will investigate the impact on patient satisfaction and analgesic consumption after surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

General anesthesia will be performed in all patients for arthroscopic adhesive capsulitis shoulder surgeries. In the first group of patients (Group IPSB), interscalene brachial plexus block will be applied 30 minutes before surgery, while interscalene brachial plexus block and suprascapular nerve block (SSNB) administration to the second group patients (Group SSNB) before surgery. Patients in the third group (Group C) will be considered the control group and no block will be performed. Patient-controlled analgesia (PCA) with morphine will be used in all three groups for postoperative analgesia. Preoperative hemodynamic data of patients, postoperative pain scores (VAS), morphine consumption, patient satisfaction score, requirement of additional analgesia and observed side effects were recorded. Consumption of analgesia 24 hours after surgery and patient satisfaction will be evaluated.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • 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 Locations

  • Turkey
    • Talas
      • Kayseri, Talas, Turkey, 38039
        • Sibel Seckin Pehlivan

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

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I- ASA II Patients

Exclusion Criteria:

  • history of allergy to the study medication
  • refusal to participate

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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group IPSB
In the first group of patients (Group IPSB), ultrasound-guided interscalene brachial plexus block will be applied 30 minutes before surgery.
Procedure: interscalene brachial plexus block
Single shot ultrasound guided interscalene brachial plexus block will be performed preoperatively to patients.Patient-controlled analgesia (PCA) with morphine will be used for postoperative analgesia.
Active Comparator: Group SSNB
In the second group of patients, ultrasound-guided interscalene brachial plexus block and suprascapular nerve block will be applied 30 minutes before surgery.
Procedure: suprascapular nerve block
Single shot ultrasound guided interscalene brachial plexus block and Suprascapular nerve block will be performed preoperatively to patients.Patient-controlled analgesia (PCA) with morphine will be used for postoperative analgesia.
Active Comparator: Group Control
Patients in the third group (Group C), will be considered the control group and no block will be performed.
Procedure: Group Control
consist of the patient group without any procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verbal Analogue Scores
Time Frame: 24 hours after surgery
A research assistant, blinded to the group allocation, interviewed patients and collected data in the 24 hours postoperative period.Verbal Analog Pain Score value will be the lowest 0 and the highest 10. At the highest value, the patient's pain is at its maximum. and whether higher scores mean worse outcome.
24 hours after surgery
opioid consumption
Time Frame: 24 hours after surgery
In the recovery room all patients will be given a patient-controlled analgesia device containing morphine and 24 hours postoperative period will be recorded.
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications of the procedures
Time Frame: During the blocks and 24 hours after surgery
The complications of the intervations will be recorded
During the blocks and 24 hours after surgery

Collaborators and Investigators

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

Sponsor

TC Erciyes University

Investigators

  • Principal Investigator: Sibel Pehlivan, MD, TC Erciyes University

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)

February 22, 2021

Primary Completion (Actual)

December 29, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

February 21, 2021

First Submitted That Met QC Criteria

February 21, 2021

First Posted (Actual)

February 24, 2021

Study Record Updates

Last Update Posted (Actual)

July 29, 2022

Last Update Submitted That Met QC Criteria

July 28, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/580

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De- identified individual participant data for all primary and secondary outcome measures will be made available.

IPD Sharing Time Frame

Data will be available within 24 months of study completion.

IPD Sharing Access Criteria

Data accept requests will be reviewed by an external independent Review Panel.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

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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