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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: intraarticular dexamethasone; Procedure: interscalene dexamethasone; Procedure: serum phsyologic

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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Kayseri, Turkey, 38039
    • Erciyes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	Procedure: intraarticular dexamethasone; 2ml 8 mg dexamethasone administration for intraarticular; Other Names: dekort
ACTIVE_COMPARATOR: 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	Procedure: interscalene dexamethasone; 2ml 8 mg dexamethasone administration interscalene brachial plexus added 30 ml 0.5 % bupivacaine; Other Names: dekort
PLACEBO_COMPARATOR: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
analgesic consumption	morphine consumption (patient controlled analgesia procedure) was recorded	postoperative 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog scale	Visual analog scale on rest and movement was recorded	postoperative 1 day

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Investigators: Principal Investigator: Fatih M KURT, Resident, TC Erciyes University; Study Director: Gülen GÜLER, Prof., TC Erciyes University

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ACTUAL): January 1, 2015
• Study Completion (ACTUAL): January 1, 2015

Study Registration Dates

• First Submitted: December 30, 2013
• First Submitted That Met QC Criteria: December 30, 2013
• First Posted (ESTIMATE): January 1, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): March 5, 2015
• Last Update Submitted That Met QC Criteria: March 3, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: dexamethasone; interscalene brachial plexus block; intraarticular injection
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101
• Other Study ID Numbers: 2013/639