Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Interscalene Block

Postoperative Complications Clinical Trial

— IBBB  

Official title:

Comparison Between Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Ultrasound Guided Interscalene Block During Shoulder Arthroscopy: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03940469
• Other study ID #: Interscalene Dexmedetomidine
• Status: Completed
• Phase: Phase 4
• Start date: July 3, 2016
• Est. completion date: January 1, 2019

Study information

• Verified date: May 2019
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 a2 agonists

• All patients with hypertension, cardiac, hepatic, renal or pulmonary diseases, - Patients who were under treatment by a2 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.

Related Conditions & MeSH terms

• Postoperative Analgesia
• Postoperative Complications

Intervention

Drug:
• Saline
2 ml normal saline
• Dexamethasone Injection
8 mg dexamethasone
• Dexmedetomidine Hydrochloride
100 microgram dexmedetomidine

Locations

Country	Name	City	State
Egypt	Ashraf Eskandr	Shibin Al Kawm	Menoufiya

Sponsors (4)

Lead Sponsor	Collaborator
Menoufia University	Basma Abdelhamid Fathy, Mamdoh Elsayed Lotfy, Osama Abdallah Elsharkawy

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in postoperative analgesia	Assessed by measuring severity of pain by visual analog score(score 0 to 10 cm with 0= no pain and 10=worst pain imaginable).	During first 2 days after surgery
Secondary	Postoperative analgesic requirement	Total amount of paracetamol required in mg	During first 2 days after surgery
Secondary	Hemodynamic parameter	Heart rate	During first 2 days after surgery
Secondary	Hemodynamic parameter	Mean arterial blood pressure	During first 2 days after surgery