Intravenous and Perineural Dexamethasone for Brachial Plexus Block in Hand Surgery

NCT03512223 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 2017H0244
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the if the administration of dexamethasone both around the nerve and in the vein (perineural and intravenous (IV)) will prolong the duration of pain relief from ropivacaine when compared with ropivacaine local block alone or when administered along with IV dexamethasone in patients undergoing hand surgery.

Conditions

Hand Surgery

Outcome Measures

Primary Outcomes (1)

• Duration of anesthetic blockade

  • The duration of anesthetic blockade measured by the time from performing the perineural block to the first reported pain at the surgical site between groups

  48 hours

Secondary Outcomes (5)

• Duration of motor block

  48 hours

• Patient satisfaction on a scale of 0-10 (0=not satisfied at all 10=very satisfied) of pain management

  48 hours

• 48-hour postoperative units of oral morphine consumption

  48 hours

• the incidence of nausea and/or vomiting within 48 hour of the block

  48 hours

• • Rebound pain on a scale of 0-10 (0=no pain 10=worst possible pain), which is the worst level of pain experienced within the 2 hours after the block wore off

  48 hours

Study Arms (3)

Group A (IV dexamethasone)

EXPERIMENTAL

Perineural (30ml of 0.75% ropivacaine + 0.5 ml normal saline) and IV (9.0 ml normal saline + 1 ml of 10 mg/ml Dexamethasone)

Drug: Dexamethasone

Group B (IV + perineural dexamethasone)

EXPERIMENTAL

(IV + perineural dexamethasone): Perineural (30ml of 0.75% ropivacaine + 0.5 ml of 10 mg/ml Dexamethasone) and IV (9.5 ml normal saline + 0.5 ml of 10 mg/ml Dexamethasone)

Drug: Dexamethasone

Group C (control with no adjuvant dexamethasone)

NO INTERVENTION

Perineural (30ml of 0.75 ropivacaine + 0.5 ml normal saline) and IV (10 ml normal saline)

Interventions

Dexamethasone DRUG

Intravenous and Perineural Dexamethasone for Brachial Plexus Block

Group A (IV dexamethasone); Group B (IV + perineural dexamethasone)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male and female patients age 18-80
• Undergoing distal radius ORIF (open reduction internal fixation) or CMC (Carpometacarpal) arthroplasty
• ASA (American Society of Anesthesiologists) I, II,III
• Patients who provide a signed written informed consent
• Have a valid phone number and be able to speak, read, and write in English

You may not qualify if:

• Any documented cognitive or psychological disorders that, in the opinion of the principal investigator, can interfere with the patients' pain perception
• Diabetes Mellitus
• Vulnerable populations: pregnant females, prisoners, breast feeding
• Contraindication to nerve block: local infections, bleeding disorders, shoulder deformity, allergy to local anesthetic or dexamethasone
• Severe lung disease, known contralateral phrenic nerve injury
• Previous history of chronic pain diseases requiring consistent analgesic therapy for at least 1 month prior to surgery
• Presence of any medical condition that, in the opinion of the principal investigator, should exclude the patient from the study
• BMI ≥ 40 kg/m2

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

• Hussain N, Speer J, D'Souza RS, Palettas M, Abdel-Rasoul M, Uribe A, Weaver TE, Kushelev M, Coffman J, Abdallah FW. Exploring the Additive or Synergistic Effects of the Systemic and Perineural Routes of Dexamethasone as Adjuncts to Supraclavicular Block: A Randomized Controlled Trial. Anesthesiology. 2025 Jun 1;142(6):1127-1137. doi: 10.1097/ALN.0000000000005433. Epub 2025 Mar 4.

  PMID: 40036049 DERIVED

• Bei T, Liu J, Huang Q, Wu J, Zhao J. Perineural Versus Intravenous Dexamethasone for Brachial Plexus Block: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Pain Physician. 2021 Sep;24(6):E693-E707.

  PMID: 34554686 DERIVED

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Michael Kushelev, MD

  Assistant Professor-Clinical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor-Clinical

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 30, 2018
• Study Start: October 23, 2018
• Primary Completion: October 20, 2024
• Study Completion: October 20, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

US (1)