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Completed

NCT Number: NCT04694105

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Alini Univeristy Hospital

Cairo, Giza Governorate, 11451, Egypt

About this study

This randomized, controlled double blinded study included 42 adult patients undergoing arteriovenous fistula surgery. Ultrasound-guided supraclavicular brachial plexus block was initiated after placement of full monitoring . Supraclavicular brachial plexus block was achieved with the use of total volume 32 ml of anesthetic drugs in all patients. Bupivacaine 30 ml 0.25% was combined with 2 ml normal saline (control group A, n=14), Bupivacaine 30 ml 0.25% was combined with 50 microgram (0.5 ml) peri-neural dexmedetomidine plus 1.5 ml normal saline ( dexmedetomidine group B ,n=14), or Bupivacaine 30 ml 0.25% was combined with 4 mg peri neural dexamethasone (2 ml) ( dexamethasone group C, n=14).The onset and duration of sensory and motor blocks, the time to first request to postoperative rescue analgesic, Richmond Agitation-Sedation Score, hemodynamic data, visual analogue pain scores, were reported at predetermined time assessment points. Postoperative rescue intravenous fentanyl consumption over 24 hours and complications occurred were recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Other names: precedex

Dexamethasone

Drug

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

Other names: decadrone

Saline

Drug

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

Other names: normal saline

Primary outcomes

  1. Duration of analgesia

    Time frame: "UP to 4 hours post operative"

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

Secondary outcomes

  1. Pain scores.

    Time frame: "at 8 and 24 hours post operative"

    Severity of pain at the surgical site (VAS) score

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Peri-neural Dexmedetomidine Versus Dexamethasone as an Adjuvant to Bupivacaine Single Injection in Ultrasoundguided Supraclavicular Brachial Plexus Block for Arteriovenous Fistula: A Randomized Controlled Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 5, 2021
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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