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

NCT ID: NCT04694105

Last Updated: 2021-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-01-12

Brief Summary

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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

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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.

Conditions

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Brachial Plexus Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers
double blind both anesthetist and patient not aware about type of local anesthesia

Study Groups

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dexmedetomidine

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine injection

Intervention Type 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

dexamethasone

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

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

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

control group

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

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

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

Interventions

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Dexmedetomidine injection

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

Intervention Type DRUG

Dexamethasone

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

Intervention Type DRUG

saline

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

Intervention Type DRUG

Other Intervention Names

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precedex decadrone normal saline

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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mahmoud salem soliman

Head of intensive care unit at new kaser al ainy teaching hospital , lecterur of anaesthesia and intensive care cairo universty

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tarek A Radwan, MD

Role: STUDY_DIRECTOR

Cairo University

Locations

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Kasr Alini Univeristy Hospital

Cairo, Giza Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type RESULT
PMID: 17865904 (View on PubMed)

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.

Reference Type RESULT
PMID: 26695877 (View on PubMed)

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.

Reference Type RESULT
PMID: 23513068 (View on PubMed)

Other Identifiers

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regional block adjuvants

Identifier Type: -

Identifier Source: org_study_id

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