Analgesic Effect of Intra-articular Dexamethasone and Dexamethasone Added to Bupivacaine in Interscalene Brachial Plexus
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
1 other identifier
interventional
75
1 country
1
Brief Summary
the aim of this study was to investigate the analgesic efficacy of intra articular dexamethasone administration for arthroscopic shoulder surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 postoperative-pain
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2013
CompletedFirst Posted
Study publicly available on registry
January 1, 2014
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedMarch 5, 2015
March 1, 2015
1 year
December 30, 2013
March 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
analgesic consumption
morphine consumption (patient controlled analgesia procedure) was recorded
postoperative 1 day
Secondary Outcomes (1)
visual analog scale
postoperative 1 day
Study Arms (3)
intraarticular dexamethasone
ACTIVE COMPARATORinterscalene 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 dexamethasone
ACTIVE COMPARATORinterscalene 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
serum phsyologic
PLACEBO COMPARATORinterscalene 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
2ml 8 mg dexamethasone administration for intraarticular
2ml 8 mg dexamethasone administration interscalene brachial plexus added 30 ml 0.5 % bupivacaine
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
Eligibility Criteria
You may qualify if:
- between 18-65 years
- arthroscopic shoulder surgery
- no known allergies to drugs
- ASA 1-2 patients
You may not qualify if:
- history of diabetes
- history of chronic pain treatment
- pregnancy
- severe bronchopulmonary disease
- systemic glucocorticoid use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erciyes university hospital
Kayseri, 38039, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fatih M KURT, Resident
TC Erciyes University
- STUDY DIRECTOR
Gülen GÜLER, Prof.
TC Erciyes University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- resident
Study Record Dates
First Submitted
December 30, 2013
First Posted
January 1, 2014
Study Start
January 1, 2014
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
March 5, 2015
Record last verified: 2015-03