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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02026050
• Other study ID #: 2013/639
• Status: Completed
• Phase: Phase 4
• First received: December 30, 2013
• Last updated: March 3, 2015
• Start date: January 2014
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• intraarticular dexamethasone
2ml 8 mg dexamethasone administration for intraarticular
• interscalene dexamethasone
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

Locations

Country	Name	City	State
Turkey	Erciyes university hospital	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	analgesic consumption	morphine consumption (patient controlled analgesia procedure) was recorded	postoperative 1 day	No
Secondary	visual analog scale	Visual analog scale on rest and movement was recorded	postoperative 1 day	No