Analgesic Effect of Intra-articular Dexamethasone and Dexamethasone Added to Bupivacaine in Interscalene Brachial Plexus

NCT ID: NCT02026050

Last Updated: 2015-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-01-31

Brief Summary

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the aim of this study was to investigate the analgesic efficacy of intra articular dexamethasone administration for arthroscopic shoulder surgery.

Detailed Description

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shoulder surgery can be very painful and interscalene brachial plexus block is the gold standard in the management of acute pain after shoulder surgery. various local anaesthetic mixtures can be used to prolong local anaesthesia duration and epinephrine , opioids and dexamethasone are frequently used for this purpose. dexamethasone has also been found the prolong the duration of lidocaine axillary blocks and intravenous regional anaesthesia. intraarticular administration of medicines can be used for management of joint pain and opioids , local anaesthetics and dexamethasone are used for this purpose.In addition, there are no studies available to compare the different treatment methods used in clinical practice directly.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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intraarticular dexamethasone

interscalene brachial plexus block was preoperative performed 30 ml 0.5 % bupivacaine+ 2 ml serum phsyologic and after surgery 2 ml 8 mg dexamethasone+ 8 ml serum phsyologic administration for intraarticular

Group Type ACTIVE_COMPARATOR

intraarticular dexamethasone

Intervention Type PROCEDURE

2ml 8 mg dexamethasone administration for intraarticular

interscalene dexamethasone

interscalene brachial plexus was preoperative performed 30 ml 0.5 % bupivacaine added 2 ml 8mg dexamethasone and after surgery 10 ml serum phsyologic administration for intraarticular

Group Type ACTIVE_COMPARATOR

interscalene dexamethasone

Intervention Type PROCEDURE

2ml 8 mg dexamethasone administration interscalene brachial plexus added 30 ml 0.5 % bupivacaine

serum phsyologic

interscalene brachial plexus block was preoperative performed 30 ml 0.5 % bupivacaine+ 2ml serum phsyologic and after surgery 10 ml serum phsyologic administration for intraarticular

Group Type PLACEBO_COMPARATOR

serum phsyologic

Intervention Type PROCEDURE

interscalene brachial plexus block was preoperative performed 30 ml 0.5 % bupivacaine+ 2ml serum phsyologic and after surgery 10 ml serum phsyologic administration for intraarticular

Interventions

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intraarticular dexamethasone

2ml 8 mg dexamethasone administration for intraarticular

Intervention Type PROCEDURE

interscalene dexamethasone

2ml 8 mg dexamethasone administration interscalene brachial plexus added 30 ml 0.5 % bupivacaine

Intervention Type PROCEDURE

serum phsyologic

interscalene brachial plexus block was preoperative performed 30 ml 0.5 % bupivacaine+ 2ml serum phsyologic and after surgery 10 ml serum phsyologic administration for intraarticular

Intervention Type PROCEDURE

Other Intervention Names

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dekort dekort

Eligibility Criteria

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Inclusion Criteria

* between 18-65 years
* arthroscopic shoulder surgery
* no known allergies to drugs
* ASA 1-2 patients

Exclusion Criteria

* history of diabetes
* history of chronic pain treatment
* pregnancy
* severe bronchopulmonary disease
* systemic glucocorticoid use
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Fatih Mehmet Kurt

resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fatih M KURT, Resident

Role: PRINCIPAL_INVESTIGATOR

TC Erciyes University

Gülen GÜLER, Prof.

Role: STUDY_DIRECTOR

TC Erciyes University

Locations

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Erciyes university hospital

Kayseri, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2013/639

Identifier Type: -

Identifier Source: org_study_id

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