Clinical trial NCT03940469: Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Interscalene Block
Official title: Comparison Between Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Ultrasound Guided Interscalene Block During Shoulder Arthroscopy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Analgesia
Postoperative Complications
Keywords: Dexmedetomidine
Dexamethasone
Interscalene
Lead sponsor: Menoufia University
Sponsor class: OTHER
Collaborators: name: Mamdoh Elsayed Lotfy
name: Osama Abdallah Elsharkawy
name: Basma Abdelhamid Fathy
First posted: 2019-05-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in postoperative analgesia
timeFrame: During first 2 days after surgery
Secondary outcomes:
measure: Postoperative analgesic requirement
timeFrame: During first 2 days after surgery
measure: Hemodynamic parameter
timeFrame: During first 2 days after surgery
measure: Hemodynamic parameter
timeFrame: During first 2 days after surgery
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Ashraf Eskandr
state: Menoufiya
Study officials:
affiliation: emeritus professor
name: mamdouh e lotfy, m.d.
role: STUDY_DIRECTOR
References: