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Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Interscalene Block (IBBB)

Primary Purpose

Postoperative Analgesia, Postoperative Complications

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Saline
Dexamethasone Injection
Dexmedetomidine Hydrochloride
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Analgesia focused on measuring Dexmedetomidine, Dexamethasone, Interscalene

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ashraf Eskandr

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Control group

Dexamethasone group

Dexmeteomidine group

Arm Description

received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block.

received 35ml levobupivacaine+8mg dexamethasone

received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Postoperative analgesic requirement
Total amount of paracetamol required in mg
Hemodynamic parameter
Heart rate
Hemodynamic parameter
Mean arterial blood pressure

Full Information

First Posted
April 10, 2019
Last Updated
May 6, 2019
Sponsor
Menoufia University
Collaborators
Mamdoh Elsayed Lotfy, Osama Abdallah Elsharkawy, Basma Abdelhamid Fathy
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1. Study Identification

Unique Protocol Identification Number
NCT03940469
Brief Title
Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Interscalene Block
Acronym
IBBB
Official Title
Comparison Between Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Ultrasound Guided Interscalene Block During Shoulder Arthroscopy: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
July 3, 2016 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University
Collaborators
Mamdoh Elsayed Lotfy, Osama Abdallah Elsharkawy, Basma Abdelhamid Fathy

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Analgesia, Postoperative Complications
Keywords
Dexmedetomidine, Dexamethasone, Interscalene

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Masking Description
both the patients and the observer were blind to the treatment groups
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block.
Arm Title
Dexamethasone group
Arm Type
Active Comparator
Arm Description
received 35ml levobupivacaine+8mg dexamethasone
Arm Title
Dexmeteomidine group
Arm Type
Active Comparator
Arm Description
received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline.
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
normal saline
Intervention Description
2 ml normal saline
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Injection
Other Intervention Name(s)
dexamethsone
Intervention Description
8 mg dexamethasone
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine Hydrochloride
Other Intervention Name(s)
dexmedetomidine
Intervention Description
100 microgram dexmedetomidine
Primary Outcome Measure Information:
Title
Changes in postoperative analgesia
Description
Assessed by measuring severity of pain by visual analog score(score 0 to 10 cm with 0= no pain and 10=worst pain imaginable).
Time Frame
During first 2 days after surgery
Secondary Outcome Measure Information:
Title
Postoperative analgesic requirement
Description
Total amount of paracetamol required in mg
Time Frame
During first 2 days after surgery
Title
Hemodynamic parameter
Description
Heart rate
Time Frame
During first 2 days after surgery
Title
Hemodynamic parameter
Description
Mean arterial blood pressure
Time Frame
During first 2 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mamdouh e lotfy, m.d.
Organizational Affiliation
emeritus professor
Official's Role
Study Director
Facility Information:
Facility Name
Ashraf Eskandr
City
Shibīn Al Kawm
State/Province
Menoufiya
ZIP/Postal Code
1234
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Interscalene Block

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