NCT04769570

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

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

February 21, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

February 22, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 29, 2022

Status Verified

July 1, 2022

Enrollment Period

10 months

First QC Date

February 21, 2021

Last Update Submit

July 28, 2022

Conditions

Shoulder Surgery

Keywords

suprascapular nerve blockinterscalene brachial plexus blockultrasoundpatient satisfaction scoreanalgesic consumption

Outcome Measures

Primary Outcomes (2)

  • Verbal Analogue Scores

    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

    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 Outcomes (1)

  • Complications of the procedures

    During the blocks and 24 hours after surgery

Study Arms (3)

Group IPSB

ACTIVE COMPARATOR

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

Group SSNB

ACTIVE COMPARATOR

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

Group Control

ACTIVE COMPARATOR

Patients in the third group (Group C), will be considered the control group and no block will be performed.

Procedure: Group Control

Interventions

interscalene brachial plexus blockPROCEDURE

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.

Group IPSB
suprascapular nerve blockPROCEDURE

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.

Group SSNB
Group ControlPROCEDURE

consist of the patient group without any procedure.

Group Control

Eligibility Criteria

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

You may qualify if:

  • ASA I- ASA II Patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sibel Seçkin Pehlivan

Kayseri, Talas, 38039, Turkey (Türkiye)

Location

Related Publications (3)

  • Bowens C Jr, Sripada R. Regional blockade of the shoulder: approaches and outcomes. Anesthesiol Res Pract. 2012;2012:971963. doi: 10.1155/2012/971963. Epub 2012 Jun 25.

    PMID: 22792099RESULT

  • Chen HP, Shen SJ, Tsai HI, Kao SC, Yu HP. Effects of Interscalene Nerve Block for Postoperative Pain Management in Patients after Shoulder Surgery. Biomed Res Int. 2015;2015:902745. doi: 10.1155/2015/902745. Epub 2015 Nov 24.

    PMID: 26688821RESULT

  • Cabaton J, Nove-Josserand L, Mercadal L, Vaudelin T. Analgesic efficacy of ultrasound-guided interscalene block vs. supraclavicular block for ambulatory arthroscopic rotator cuff repair: A randomised noninferiority study. Eur J Anaesthesiol. 2019 Oct;36(10):778-786. doi: 10.1097/EJA.0000000000001065.

    PMID: 31361631RESULT

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Sibel Pehlivan, MD

    TC Erciyes University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 21, 2021

First Posted

February 24, 2021

Study Start

February 22, 2021

Primary Completion

December 29, 2021

Study Completion

December 31, 2021

Last Updated

July 29, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be available within 24 months of study completion.
Access Criteria
Data accept requests will be reviewed by an external independent Review Panel.

Locations

TU(1)