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

Brachial Plexus Block Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04694105
• Other study ID #: regional block adjuvants
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: January 12, 2020

Study information

• Verified date: December 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 12, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Brachial Plexus Block

Intervention

Drug:
• 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
• Dexamethasone
perineural injection of Bupivacaine 30 ml 0.25% combined with 4 mg peri neural dexamethasone (2 ml)
• saline
perineural injection of Bupivacaine 30 ml 0.25% combined with 2 ml normal saline

Locations

Country	Name	City	State
Egypt	Kasr Alini Univeristy Hospital	Cairo	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

Kulenkampff D. BRACHIAL PLEXUS ANAESTHESIA: ITS INDICATIONS, TECHNIQUE, AND DANGERS. Ann Surg. 1928 Jun;87(6):883-91. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain scores.	Severity of pain at the surgical site (VAS) score	"at 8 and 24 hours post operative"