Dexamethasone Dose in Low Volume Bupivacaine USG Supraclavicular Block

NCT03043495 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: DexSupraClav
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

A dose-ranging study to test various doses of Dexamethasone (2, 4 \& 8 mg) to be used as an adjuvant to Local anesthetic drugs in ultrasound guided low volume Supraclavicular brachial plexus block to find the best balance between valuable effects (mainly duration of analgesic Effect) and side-effects (mainly increased random blood sugar levels)

Conditions

Dexamethasone; Supraclavicular Brachial Plexus Block

Keywords

dexamethasone; supraclavicular brachial plexus block; ultrasound

Outcome Measures

Primary Outcomes (1)

• Duration of analgesia

  The time between injection of Local anesthetic mixture during performing the block and time of administration of the first dose of rescue analgesia at VAS equal or more than 4

  24 hours

Secondary Outcomes (5)

• Duration of motor block

  24 hours

• Patient Satisfaction score

  24 hours

• Random Blood glucose levels

  24 hours

• Incidence of PONV

  24 hours

• Incidence of complications

  24 hours

Study Arms (4)

Group A

ACTIVE COMPARATOR

N-12 Ultrasound guided supraclavicular brachial plexus block will be preformed using a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 0.5ml (2mg) Dexamethasone, 1.5ml Normal saline.

Procedure: Ultrasound guided supraclavicular brachial plexus block; Drug: Dexamethasone

Group B

ACTIVE COMPARATOR

N-12 Ultrasound guided supraclavicular brachial plexus block will be preformed using a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 1ml (4mg) Dexamethasone, 1ml Normal saline.

Procedure: Ultrasound guided supraclavicular brachial plexus block; Drug: Dexamethasone

Group C

ACTIVE COMPARATOR

N-12 Ultrasound guided supraclavicular brachial plexus block will be preformed using a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 2ml (8mg) Dexamethasone.

Procedure: Ultrasound guided supraclavicular brachial plexus block; Drug: Dexamethasone

Group Control

ACTIVE COMPARATOR

N-12 Ultrasound guided supraclavicular brachial plexus block will be preformed using a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 2ml Normal saline.

Procedure: Ultrasound guided supraclavicular brachial plexus block

Interventions

Ultrasound guided supraclavicular brachial plexus block PROCEDURE

ultrasound guided Supraclavicular brachial plexus block

Group A; Group B; Group C; Group Control

Dexamethasone DRUG

Various doses of Dexamethasone (2, 4 \& 8 mg) to be used as an Adjuvant to Local anesthetic drugs

Also known as: Decadron

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing surgeries in the upper limb (arm, forearm or hand)

You may not qualify if:

• Coagulopathies (with prothrombin concentration less than 60% or INR more than 1.5)
• In-ability to postpone anti-coagulation medications.
• Infection or injury or a lesion at the block site.
• Suspected cervical vertebral column injury necessitating using a neck collar.
• A compromised lung on the contralateral side of the block (Pneumothorax, hemothorax or Pneumonectomy).
• Traumatic vascular injuries or operative interventions (Surgical harvesting) involving arteries of the upper limb on the operative side.
• Patients with communication difficulties.
• Hypersensitivity to local anesthetics and/or Dexamethasone.
• Patients on perioperative intravenous (IV) steroids.

Sponsors & Collaborators

• Eslam Ayman Mohamed Shawki: lead

Study Sites (1)

Faculty of medicine, Cairo University teaching hospitals (Kasr Alainy)

Cairo, Cairo Governorate, Egypt

RECRUITING

Related Publications (6)

• Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review of current techniques. Anaesthesia. 2010 Jun;65(6):608-624. doi: 10.1111/j.1365-2044.2009.06231.x.

  PMID: 20565394 BACKGROUND

• Neal JM, Hebl JR, Gerancher JC, Hogan QH. Brachial plexus anesthesia: essentials of our current understanding. Reg Anesth Pain Med. 2002 Jul-Aug;27(4):402-28. doi: 10.1053/rapm.2002.34377. No abstract available.

  PMID: 12132064 BACKGROUND

• Al Harbi M, Kaki AM, Kamal A, El-Dawlatly A, Daghistani M, El Tahan MR. A survey of the practice of regional anesthesia in Saudi Arabia. Saudi J Anaesth. 2013 Oct;7(4):367-70. doi: 10.4103/1658-354X.121041.

  PMID: 24348284 BACKGROUND

• Rosenfeld DM, Ivancic MG, Hattrup SJ, Renfree KJ, Watkins AR, Hentz JG, Gorlin AW, Spiro JA, Trentman TL. Perineural versus intravenous dexamethasone as adjuncts to local anaesthetic brachial plexus block for shoulder surgery. Anaesthesia. 2016 Apr;71(4):380-8. doi: 10.1111/anae.13409. Epub 2016 Feb 22.

  PMID: 26899862 BACKGROUND

• Desmet M, Braems H, Reynvoet M, Plasschaert S, Van Cauwelaert J, Pottel H, Carlier S, Missant C, Van de Velde M. I.V. and perineural dexamethasone are equivalent in increasing the analgesic duration of a single-shot interscalene block with ropivacaine for shoulder surgery: a prospective, randomized, placebo-controlled study. Br J Anaesth. 2013 Sep;111(3):445-52. doi: 10.1093/bja/aet109. Epub 2013 Apr 15.

  PMID: 23587875 BACKGROUND

• Albrecht E, Kern C, Kirkham KR. A systematic review and meta-analysis of perineural dexamethasone for peripheral nerve blocks. Anaesthesia. 2015 Jan;70(1):71-83. doi: 10.1111/anae.12823. Epub 2014 Aug 14.

  PMID: 25123271 RESULT

MeSH Terms

Interventions

Dexamethasone; Calcium Dobesilate

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

Eslam A Shawki, M.D.

CONTACT

+201225771017; eslam.ayman@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patient and the attending anesthetist who will manage the patient intra-operatively and perform the block, will be blinded to the patient group allocation All recorded values will be obtained by personnel blinded to the group allocation of the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of anesthesia, SICU & Pain Management

Model Details: The patients will be randomized to 4 groups: * Group A: N-12 will receive a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 0.5ml (2mg) Dexamethasone, 1.5ml Normal saline. * Group B: N-12 will receive a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 1ml (4mg) Dexamethasone, 1ml Normal saline. * Group C: N-12 will receive a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 2ml (8mg) Dexamethasone. * Group Control: N-12 will receive a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 2ml Normal saline.

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 6, 2017
• Study Start: October 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: June 1, 2018
• Last Updated: February 6, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)