Peri-neural Dexmedetomidine Versus Dexamethasone for Supraaclavicular Block Adjuvant to Bupivacaine Supraclavicular Brachial Plexus Block

NCT04694105 | Completed DMC

• 1 other identifier: regional block adjuvants
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

to assessthe impact of addition of Dexmedetomidine or Dexamethasone to Bupivacaine, on Duration of analgesia (time in hours to the first report of postoperative pain )at the surgical site

Conditions

Brachial Plexus Block

Keywords

dexmedetomidine; dexamethasone

Outcome Measures

Primary Outcomes (1)

• Duration of analgesia

  (time in hours to the first report of postoperative pain at the surgical site, administered of opioid when VAS score was\>4).

  "UP to 4 hours post operative"

Secondary Outcomes (1)

• Pain scores.

  "at 8 and 24 hours post operative"

Study Arms (3)

dexmedetomidine

ACTIVE COMPARATOR

Bupivacaine 30 ml 0.25% was combined with 50 microgram (0.5 ml) peri-neural dexmedetomidine plus 1.5 ml normal saline

Drug: Dexmedetomidine injection

dexamethasone

ACTIVE COMPARATOR

Bupivacaine 30 ml 0.25% was combined with 4 mg peri neural dexamethasone (2 ml)

Drug: Dexamethasone

control group

PLACEBO COMPARATOR

Bupivacaine 30 ml 0.25% was combined with 2 ml normal saline

Drug: saline

Interventions

Dexmedetomidine injection DRUG

perineural injection of Bupivacaine 30 ml 0.25% combined with 50 microgram (0.5 ml) peri-neural dexmedetomidine plus 1.5 ml normal saline

Also known as: precedex

dexmedetomidine

Dexamethasone DRUG

perineural injection of Bupivacaine 30 ml 0.25% combined with 4 mg peri neural dexamethasone (2 ml)

Also known as: decadrone

dexamethasone

saline DRUG

perineural injection of Bupivacaine 30 ml 0.25% combined with 2 ml normal saline

Also known as: normal saline

control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All the patients included in the study aged 18 to 60 years old were on chronic hemodialysis and they had a hemodialysis session one day before the block performance

You may not qualify if:

• Neurological, neuromuscular, psychiatric disorders, hepatic, respiratory, or cardiac diseases; coagulation disorders; infection at the block injection site; patients with a body mass index more than 35; or patients who refused the procedure

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alini Univeristy Hospital

Cairo, Giza Governorate, 11451, Egypt

Location

Related Publications (3)

• Kulenkampff D. BRACHIAL PLEXUS ANAESTHESIA: ITS INDICATIONS, TECHNIQUE, AND DANGERS. Ann Surg. 1928 Jun;87(6):883-91. doi: 10.1097/00000658-192806000-00015. No abstract available.

  PMID: 17865904 RESULT

• Neal JM. Ultrasound-Guided Regional Anesthesia and Patient Safety: Update of an Evidence-Based Analysis. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):195-204. doi: 10.1097/AAP.0000000000000295.

  PMID: 26695877 RESULT

• Ji F, Li Z, Nguyen H, Young N, Shi P, Fleming N, Liu H. Perioperative dexmedetomidine improves outcomes of cardiac surgery. Circulation. 2013 Apr 16;127(15):1576-84. doi: 10.1161/CIRCULATIONAHA.112.000936. Epub 2013 Mar 19.

  PMID: 23513068 RESULT

MeSH Terms

Interventions

Dexmedetomidine; Dexamethasone; Sodium Chloride; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Tarek A Radwan, MD

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: double blind both anesthetist and patient not aware about type of local anesthesia
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of intensive care unit at new kaser al ainy teaching hospital , lecterur of anaesthesia and intensive care cairo universty

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: January 5, 2021
• Study Start: June 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: January 12, 2020
• Last Updated: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)