Postoperative Pain in Shoulder Surgery | NCT06265571

Studies
Postoperative Pain in Shoulder Surgery

NCT06265571

Sponsor

Eskisehir Osmangazi University

Status

Completed

Last Update Posted

Feb 20, 2024Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Pain, Postoperative

Interventions

perineural injection

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2020Actual

Primary Completion Date

Jun 15, 2021Actual

Completion Date

Jul 15, 2021Actual

First Submitted Date

Sep 11, 2023

First Submission Date that Met QC Criteria

Feb 16, 2024

First Posted Date

Feb 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2024

Last Update Posted Date

Feb 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

After the approval of the ethics committee, the files of the patients who underwent arthroscopic shoulder surgery between 01.01.2019 and 01.03.2020 were evaluated retrospectively.

Data were recorded including age, gender, duration of anesthesia, duration of surgery, postoperative analgesia consumption, complications such as respiratory distress due to hemidiaphragmatic paralysis and complications such as hematoma and nerve damage due to block intervention.

Detailed Description

Patients who underwent arthroscopic shoulder surgery and underwent USG-guided interscalene block and concomitant suprascapular block were included in the study. We tried to determine whether there is a difference between different dose regimens in order to determine the effective analgesic dose and minimize the side effects of dose-dependent interscalene block applications.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GROUP I		Interscalene block (group I)15 ml of 0.5% bupivacaine was applied with a single injection to 12 of 18 patients,	Other: perineural injection
GROUP II		7.5 ml of interscalene and 7.5 ml of suprascapular block (GROUP II) were applied to 6 patients with posterior approach.	Other: perineural injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
perineural injection	Other	perineural injection of local anesthestetic for postoperative pain management	GROUP I GROUP II

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
rescue analgesia	postoperative pain score (VAS) > 4 required to rescue analgesia	between 01.01.2019 and 01.03.2020
difference between the analgesic methods		between 01.01.2019 and 01.03.2020

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

arthroscopic shoulder surgery full data form

Exclusion Criteria:

chronic obstructive lung disease chronic opoid consumption missing data from the postoperative pain form

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

>18 years old patients undergoing arthroscopic shoulder surgery by the same surgeon.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ferda YAMAN, Assoc prof	University of Eskişehir Osmangazi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ferda YAMAN		Eskişehir	Odunpazarı	26040	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

reterospectively completed

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided