Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Interscalene Block

Phase 4

Completed

• Conditions: Postoperative Complications; Postoperative Analgesia
• Interventions: Drug: Saline; Drug: Dexamethasone Injection; Drug: Dexmedetomidine Hydrochloride

• Registration Number: NCT03940469
• Lead Sponsor: Menoufia University

Brief Summary

The investigators compared between dexamethasone and dexmedetomidine when added to levobupivacaine in the quality and duration of ultrasound-guided interscalene block during shoulder arthroscopy.

Detailed Description

Sixty patients were enrolled and divided into three groups 20 each, Group C received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block. Group H received 35ml levobupivacaine+8mg dexamethasone under ultrasound guided interscalene block. Group D received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline. The primary outcome was the postoperative pain which was assessed by Visual analog score(VAS), the secondary outcomes were the onset and duration of sensory and motor block, the total amount of analgesic requirement, and blood cortisol level.

Study Timeline

• Study Start: 2016-07-03
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-01
• Study First Submitted: 2019-04-10
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-06
• Last Update Submitted: 2019-05-06
• Study First Posted: 2019-05-07
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Sixty healthy patients ASA I-II
• Aged 18-60 years
• Of both sexes
• Scheduled for shoulder arthroscopy using ultrasound interscalene block were enrolled.

Exclusion Criteria

• Patients with a history of any allergic reactions to levobupivacaine, dexamethasone or α2 agonists
• All patients with hypertension, cardiac, hepatic, renal or pulmonary diseases, - Patients who were under treatment by α2 agonist or antagonists
• Pregnant women
• Psychiatric patients
• Patients with a previous history or clinical evidence of central or peripheral neurological disease
• Coagulopathy or anticoagulant/antiaggregant therapy
• Contralateral phrenic nerve paresis
• Patients who have an infection at the site of the block.
• Every patient who had an anatomical or vascular abnormality in the upper extremity were excluded from this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Saline	received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block.
Dexamethasone group	Dexamethasone Injection	received 35ml levobupivacaine+8mg dexamethasone
Dexmeteomidine group	Dexmedetomidine Hydrochloride	received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline.

Primary Outcome Measures

Name	Time	Method
Changes in postoperative analgesia	During first 2 days after surgery	Assessed by measuring severity of pain by visual analog score(score 0 to 10 cm with 0= no pain and 10=worst pain imaginable).

Secondary Outcome Measures

Name	Time	Method
Hemodynamic parameter	During first 2 days after surgery	Mean arterial blood pressure
Postoperative analgesic requirement	During first 2 days after surgery	Total amount of paracetamol required in mg

Trial Locations

Locations (1)

Ashraf Eskandr; 🇪🇬 Shibīn Al Kawm, Menoufiya, Egypt