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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
intraarticular dexamethasone
interscalene dexamethasone
serum phsyologic
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring dexamethasone, intraarticular injection, interscalene brachial plexus block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Erciyes university hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

intraarticular dexamethasone

interscalene dexamethasone

serum phsyologic

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

analgesic consumption
morphine consumption (patient controlled analgesia procedure) was recorded

Secondary Outcome Measures

visual analog scale
Visual analog scale on rest and movement was recorded

Full Information

First Posted
December 30, 2013
Last Updated
March 3, 2015
Sponsor
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT02026050
Brief Title
Analgesic Effect of Intra-articular Dexamethasone and Dexamethasone Added to Bupivacaine in Interscalene Brachial Plexus
Official Title
Phase 4 Study of Comparison of Postoperative Analgesic Effect of Intra-articular Dexamethasone and Dexamethasone Added to Bupivacaine in Interscalene Brachial Plexus Blockade for Arthroscopic Shoulder Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
dexamethasone, intraarticular injection, interscalene brachial plexus block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intraarticular dexamethasone
Arm Type
Active Comparator
Arm Description
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
Arm Title
interscalene dexamethasone
Arm Type
Active Comparator
Arm Description
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
Arm Title
serum phsyologic
Arm Type
Placebo Comparator
Arm Description
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
Intervention Name(s)
intraarticular dexamethasone
Other Intervention Name(s)
dekort
Intervention Description
2ml 8 mg dexamethasone administration for intraarticular
Intervention Type
Procedure
Intervention Name(s)
interscalene dexamethasone
Other Intervention Name(s)
dekort
Intervention Description
2ml 8 mg dexamethasone administration interscalene brachial plexus added 30 ml 0.5 % bupivacaine
Intervention Type
Procedure
Intervention Name(s)
serum phsyologic
Intervention Description
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
Primary Outcome Measure Information:
Title
analgesic consumption
Description
morphine consumption (patient controlled analgesia procedure) was recorded
Time Frame
postoperative 1 day
Secondary Outcome Measure Information:
Title
visual analog scale
Description
Visual analog scale on rest and movement was recorded
Time Frame
postoperative 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatih M KURT, Resident
Organizational Affiliation
TC Erciyes University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gülen GÜLER, Prof.
Organizational Affiliation
TC Erciyes University
Official's Role
Study Director
Facility Information:
Facility Name
Erciyes university hospital
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey

12. IPD Sharing Statement

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

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