Effect of Intravenous Dexmedetomidine Versus Dexamethasone for Management of Repound Pain After Supraclavicular Brachial Plexus Block

NCT06304909 | Not Yet Recruiting Phase 1

• 1 other identifier: 2080278
• Study Type: interventional
• Target: 111
• Locations: 0 countries
• Sites: N/A

Brief Summary

Effect of intravenous dexmedetomidine versus dexamethasone for management of repound pain after supraclavicular brachial plexus block.

Conditions

Trauma Injury

Outcome Measures

Primary Outcomes (1)

• The incidence of rebound pain.

  Rebound pain is defined as an increase from well-controlled to severe pain typically within 12\_24 h of resolution of the nerve block.

  1year

Study Arms (3)

Dexmedetomidine group will receive 0.5 mcg/kg

EXPERIMENTAL

Drug: Dexmedetomidine injection

Dexamethasone group will receive 8mg/kg

EXPERIMENTAL

Drug: Dexmedetomidine injection

Control group will receive equivalent volume of saline 0.9%.

EXPERIMENTAL

Drug: Dexmedetomidine injection

Interventions

Dexmedetomidine injection DRUG

Dexmedetomidine group will receive 0.5 mcg/kg

Also known as: Dexamethasone

Control group will receive equivalent volume of saline 0.9%.; Dexamethasone group will receive 8mg/kg; Dexmedetomidine group will receive 0.5 mcg/kg

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients between 20\_60 years old
• Patients with ASA clinical status I/II
• Patients scheduled for peripheral nerve block for upper extremity surgery

You may not qualify if:

• \) they refused to participate 2) had preexisting neuropathy of the surgical limb 3) hypersensitivity to amide anesthetic 4) significant pulmonary disease 5) coagulopathy 6) sepsis 7) infection at the block site 8) hypersensitivity to dexmedetomidine \& dexamethasone

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• Kolny M, Stasiowski MJ, Zuber M, Marciniak R, Chabierska E, Pluta A, Jalowiecki P, Byrczek T. Randomized, comparative study of the effectiveness of three different techniques of interscalene brachial plexus block using 0.5% ropivacaine for shoulder arthroscopy. Anaesthesiol Intensive Ther. 2017;49(1):47-52. doi: 10.5603/AIT.2017.0009.

  PMID: 28362032 BACKGROUND

• Brattwall M, Jildenstal P, Warren Stomberg M, Jakobsson JG. Upper extremity nerve block: how can benefit, duration, and safety be improved? An update. F1000Res. 2016 May 18;5:F1000 Faculty Rev-907. doi: 10.12688/f1000research.7292.1. eCollection 2016.

  PMID: 27239291 BACKGROUND

• Falgas N, Sanchez-Valle R, Bargallo N, Balasa M, Fernandez-Villullas G, Bosch B, Olives J, Tort-Merino A, Antonell A, Munoz-Garcia C, Leon M, Grau O, Castellvi M, Coll-Padros N, Rami L, Redolfi A, Llado A. Hippocampal atrophy has limited usefulness as a diagnostic biomarker on the early onset Alzheimer's disease patients: A comparison between visual and quantitative assessment. Neuroimage Clin. 2019;23:101927. doi: 10.1016/j.nicl.2019.101927. Epub 2019 Jul 5.

  PMID: 31491836 BACKGROUND

• Hamilton DL. Rebound pain: distinct pain phenomenon or nonentity? Br J Anaesth. 2021 Apr;126(4):761-763. doi: 10.1016/j.bja.2020.12.034. Epub 2021 Feb 5. No abstract available.

  PMID: 33551124 BACKGROUND

• Bhatia P, Metta R. Rebound pain: Undesired, yet unexplored. J Anaesthesiol Clin Pharmacol. 2022 Oct-Dec;38(4):527-528. doi: 10.4103/joacp.joacp_435_22. Epub 2022 Dec 26. No abstract available.

  PMID: 36778810 BACKGROUND

• Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

  PMID: 17695343 BACKGROUND

• Hong B, Oh C, Jo Y, Chung W, Park E, Park H, Yoon S. The Effect of Intravenous Dexamethasone and Dexmedetomidine on Analgesia Duration of Supraclavicular Brachial Plexus Block: A Randomized, Four-Arm, Triple-Blinded, Placebo-Controlled Trial. J Pers Med. 2021 Dec 1;11(12):1267. doi: 10.3390/jpm11121267.

  PMID: 34945739 RESULT

MeSH Terms

Conditions

Accidental Injuries

Interventions

Dexmedetomidine; Dexamethasone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Wesam Nashat Ali, Assistant professor

  Assistant professor

  STUDY DIRECTOR

Central Study Contacts

Marwa Sayed Mohamed, physician

CONTACT

01206696502; markesh1997@gmail.com

Mohamed Mohamed Abdellatif, Professor

CONTACT

0100174 5301; mohamed.abdelatef@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: May 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share