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Clinical Trials/NCT02026050
NCT02026050CompletedPhase 4

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

TC Erciyes University1 site in 1 country75 target enrollmentStarted: January 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
75
Locations
1
Primary Endpoint
analgesic consumption

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

interscalene dexamethasone

Active Comparator

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

Intervention: interscalene dexamethasone (Procedure)

serum phsyologic

Placebo Comparator

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: serum phsyologic (Procedure)

intraarticular dexamethasone

Active Comparator

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

Intervention: intraarticular dexamethasone (Procedure)

Outcomes

Primary Outcomes

analgesic consumption

Time Frame: postoperative 1 day

morphine consumption (patient controlled analgesia procedure) was recorded

Secondary Outcomes

  • visual analog scale(postoperative 1 day)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fatih Mehmet Kurt

resident

TC Erciyes University

Study Sites (1)

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