Dexamethasone as an Adjuvant in Supraclavicular Block

April 13, 2020 updated by: Islam Mohamed Abdel Hamid Ali, Assiut University

Comparison of Analgesic Efficacy of Dexamethasone as an Adjuvant in Supraclavicular Block With Intravenous Dexamethasone After Supraclavicular Block in Patients Undergoing Forearm Surgeries

The use of dexamethasone perineurally along with local anesthetic has been shown to improve the duration of analgesia .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Acute postoperative pain can be effectively controlled with the use of peripheral nerve blocks. Use of additives further prolongs the duration of analgesia For upper limb surgeries below shoulder joint, the brachial plexus block using supraclavicular approach introduced by Kulenkampff has gained popularity. Supraclavicular approach to brachial plexus block is useful for procedures done at or below the level of elbow.

This technique involves the deposition of local anesthetic near the brachial plexus approached from immediately above the clavicle. Brachial plexus is formed by ventral rami of C5, C6, C7, C8, and T1 which forms the roots.These then continue distally to form trunks, divisions, cords,and branches Local anesthetics used alone in supraclavicular block provide analgesia for 4-8 h.

The use of dexamethasone perineurally along with local anesthetic has been shown to improve the duration of analgesia. Intravenous dexamethasone is also useful in attenuating the postoperative need for analgesics in different clinical settings even in the absence of any nerve blocks.

Hence, it is logical to compare the duration of analgesia with the use of dexamethasone in the setting of supraclavicular brachial plexus block, dexamethasone given either perineurally or intravenously.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. Patients between 18 and 60 years of age 2. Both male and female gender 3. ASA physical status Classes I and II patients 4. Patients posted for upper limb surgery below shoulder.

Exclusion Criteria:

  • 1. Patient refusal 2. Patients with bleeding disorders and those on anticoagulant therapy 3. History of allergy to local anesthetics 4. Infection at the site of block 5. Neuro deficit involving brachial plexus 6. Pregnant women 7. Patients with psychiatric behavior 8. ASA physical status Classes III and IV patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: group received dexamethasone perineural
injection dexamethasone 0.05 mg/kg perineural.
Drug: Dexamethasone injection
we use injection lignocaine 10 mL, injection bupivacaine 0.5% 20 mL, 5 mL normal saline (NS). In group , injection dexamethasone 0.05 mg/kg will be added to the solution along with IV NS 1cc while the other group will receive 0.05 mg/kg injection dexamethasone intravenously.
ACTIVE_COMPARATOR: group received dexamethasone intravenous
injection dexamethasone 0.05 mg/kg intravenously.
Drug: Dexamethasone injection
we use injection lignocaine 10 mL, injection bupivacaine 0.5% 20 mL, 5 mL normal saline (NS). In group , injection dexamethasone 0.05 mg/kg will be added to the solution along with IV NS 1cc while the other group will receive 0.05 mg/kg injection dexamethasone intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dexamethasone efficacy as an Adjuvant in Supraclavicular Block
Time Frame: 2 years
we will assess the efficacy of dexamethasone in supraclavicular anaethesia in terms of duration of analgesia and onset of motor and sensory block.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Islam Mohamed Abdel Hamid, post graduated
  • Study Director: Golinar Mohamed Fathy, professor
  • Study Director: Ahmed Mohamed Abdel Moteleb, lecturer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2021

Primary Completion (ANTICIPATED)

January 1, 2022

Study Completion (ANTICIPATED)

June 1, 2022

Study Registration Dates

First Submitted

April 10, 2020

First Submitted That Met QC Criteria

April 13, 2020

First Posted (ACTUAL)

April 14, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 13, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dexamethasone as an Adjuvant

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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