Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Interscalene Block (IBBB)

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Postoperative Analgesia
• Intervention / Treatment: Drug: Saline; Drug: Dexamethasone Injection; Drug: Dexmedetomidine Hydrochloride

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Menoufiya
    • Shibīn Al Kawm, Menoufiya, Egypt, 1234
      • Ashraf Eskandr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block.	Drug: Saline; 2 ml normal saline; Other Names: normal saline
Active Comparator: Dexamethasone group; received 35ml levobupivacaine+8mg dexamethasone	Drug: Dexamethasone Injection; 8 mg dexamethasone; Other Names: dexamethsone
Active Comparator: Dexmeteomidine group; received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline.	Drug: Dexmedetomidine Hydrochloride; 100 microgram dexmedetomidine; Other Names: dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative analgesic requirement	Total amount of paracetamol required in mg	During first 2 days after surgery
Hemodynamic parameter	Heart rate	During first 2 days after surgery
Hemodynamic parameter	Mean arterial blood pressure	During first 2 days after surgery

Collaborators and Investigators

• Sponsor: Menoufia University
• Collaborators: Mamdoh Elsayed Lotfy; Osama Abdallah Elsharkawy; Basma Abdelhamid Fathy
• Investigators: Study Director: mamdouh e lotfy, m.d., emeritus professor

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2016
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 6, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Dexamethasone; Interscalene
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexamethasone; Dexamethasone acetate; Dexmedetomidine
• Other Study ID Numbers: Interscalene Dexmedetomidine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No