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

Not Applicable

Completed

• Conditions: Brachial Plexus Block
• Interventions: Drug: Dexmedetomidine injection; Drug: saline; Drug: Dexamethasone

• Registration Number: NCT04694105
• Lead Sponsor: Cairo University

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2019-12-01
• Study Completion: 2020-01-12
• Status Verified: 2020-12
• Study First Submitted: 2020-12-18
• Study First Submitted QC: 2021-01-04
• Last Update Submitted: 2021-01-04
• Study First Posted: 2021-01-05
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine	Dexmedetomidine injection	Bupivacaine 30 ml 0.25% was combined with 50 microgram (0.5 ml) peri-neural dexmedetomidine plus 1.5 ml normal saline
control group	saline	Bupivacaine 30 ml 0.25% was combined with 2 ml normal saline
dexamethasone	Dexamethasone	Bupivacaine 30 ml 0.25% was combined with 4 mg peri neural dexamethasone (2 ml)

Primary Outcome Measures

Name	Time	Method
Duration of analgesia	"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 Outcome Measures

Name	Time	Method
Pain scores.	"at 8 and 24 hours post operative"	Severity of pain at the surgical site (VAS) score

Trial Locations

Locations (1)

Kasr Alini Univeristy Hospital; 🇪🇬 Cairo, Giza, Egypt