Intravenous and Perineural Dexamethasone for Brachial Plexus Block in Hand Surgery

Sponsor
Ohio State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03512223
Collaborator
(none)
108
Enrollment
1
Location
3
Arms
50.3
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
Early Phase 1

Detailed Description

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. Individuals who have hand surgery scheduled will be evaluated for eligibility in this study. Eligible and consenting patients will be randomly assigned to one of three groups (1:1:1) as follows: • Group A (IV dexamethasone): 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) • Group B (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) • Group C (control with no adjuvant dexamethasone): Perineural (30ml of 0.75 ropivacaine + 0.5 ml normal saline) and IV (10 ml normal saline) This study is single-blind, so the subjects will not know to which group they have been assigned. All subjects will receive at least a nerve block with a local anesthetic, or numbing agent. After written, informed consent is obtained and on the day of surgery, the research staff will collect information about the subject's medical history including allergies (seasonal and drug related), demographics (gender, age, height, weight), history of drug use, pain and nausea scores, and vital signs. All medication taken 1 month prior to treatment day will be recorded. Information will be collected from the physical examination performed by the surgeon, which is a standard procedure for the pre-operative visit, regardless of participation in the study. After being put under light sedation according to standardized sedation, as written in the protocol, one group will receive a local nerve block and numbing agent. The other two groups will receive either the nerve block and local anesthetic with intravenous dexamethasone or the nerve block and local anesthetic with both intravenous and perineural (local) dexamethasone, as described above. Details regarding the subject's surgery and anesthesia will be collected, and after your surgery, a member of the research team will provide the subject with a diary to document level of pain, movement, any episodes of nausea/vomiting, and the number of pain medicine tablets taken for up to 48 hours after surgery. The subjects will receive a follow up phone call 48 hours after the nerve block from the research team to collect the information already documented in the diary. Thus far, no evidence of dexamethasone toxicity around the nerve has been shown and no neurologic complications or infections have been reported. Only one study reported blood glucose elevations [1]. There is a potential benefit of enhancing the duration of the nerve block and therefore pain management. The results of this study will help clarify if use of dexamethasone as an adjuvant in nerve block will prolong the effect of the nerve block and reduce the heightened sensitivity to pain and burning sensation as the block wears off.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Intravenous and Perineural Dexamethasone for Brachial Plexus Block in Hand Surgery
Actual Study Start Date :
Oct 23, 2018
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Group A (IV dexamethasone)

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
Intravenous and Perineural Dexamethasone for Brachial Plexus Block

Experimental: Group B (IV + perineural dexamethasone)

(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
Intravenous and Perineural Dexamethasone for Brachial Plexus Block

No Intervention: Group C (control with no adjuvant dexamethasone)

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

Outcome Measures

Primary Outcome Measures

  1. Duration of anesthetic blockade [48 hours]

    • 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

Secondary Outcome Measures

  1. Duration of motor block [48 hours]

    • To compare the duration of motor block between groups (defined as the time between performance of the perineural block and full return of motor function in comparison to the contralateral limb)

  2. Patient satisfaction on a scale of 0-10 (0=not satisfied at all 10=very satisfied) of pain management [48 hours]

    • To compare overall patient satisfaction of pain management between groups

  3. 48-hour postoperative units of oral morphine consumption [48 hours]

    • To compare 48-hour postoperative units of oral morphine consumption between groups

  4. the incidence of nausea and/or vomiting within 48 hour of the block [48 hours]

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

  5. • 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]

    • Rebound pain (the worst pain in the 2 hours after the block wore off)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1The Ohio State University Wexner Medical CenterColumbusOhioUnited States43210

Sponsors and Collaborators

  • Ohio State University

Investigators

  • Principal Investigator: Michael Kushelev, MD, Assistant Professor-Clinical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michael Kushelev, Assistant Professor-Clinical, Ohio State University
ClinicalTrials.gov Identifier:
NCT03512223
Other Study ID Numbers:
  • 2017H0244
First Posted:
Apr 30, 2018
Last Update Posted:
Oct 19, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 19, 2021