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Analgesic Efficacy of Intravenous Dexmedetomidine for Supraclavicular Plexus Block (TwoDex)

Primary Purpose

Surgery

Status
Recruiting
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
Hôpital du Valais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgery focused on measuring locoregional anesthesia, postoperative analgesia, hand surgery, dexmedetomidine

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients undergoing elbow, forearm or hand surgery under supraclavicular brachial plexus block Patients who are ASA physical status I-III

Exclusion criteria

  • Patient refusal
  • ASA physical status IV
  • History of hypersensitivity or intolerance to dexmedetomidine
  • History of hypersensitivity or intolerance to dexamethasone
  • History of hypersensitivity or intolerance to local anesthetics
  • History of recent (< 1 year) cerebrovascular insult
  • Second or third degree heart block
  • Uncontrolled hypotension
  • Conditions contraindicating supraclavicular brachial plexus block: neurological deficit or neuropathy of the arm, severe hepatic dysfunction (Child B and C), coagulopathy, malignancy or infection in the area above the clavicle
  • Chronic opioid use
  • Pregnancy

Sites / Locations

  • Hopital du ValaisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

intravenous dexmedetomidine

Placebo

Arm Description

Patients will receive intravenous dexmedetomidine 1 mcg/kg just after the supraclavicular brachial plexus block is completed

Patients will receive intravenous placebo (normal saline) just after the supraclavicular brachial plexus is completed

Outcomes

Primary Outcome Measures

duration of analgesia
time in minutes from end of injection of local anesthetic till first analgesic request

Secondary Outcome Measures

Duration of motor block
time in minutes from completion of locoregional anesthesia and the moment the patient can again mobilize the arm
Duration of sensory block
time in minutes from completion of locoregional anesthesia and the moment the patient regains sensation of the arm
Pain scores at rest
Pain scores at rest on numeric scale, 0=no pain at all to 10=worst pain imaginable
Pain scores on movement
Pain scores on movement, on numeric scale, 0=no pain at all to 10=worst pain imaginable
Cumulative amount of opiate analgesic medication consumed
in intravenous morphine equivalents (mg)
Patient satisfaction
on 4 point Likert scale: dissatisfied / neutral / satisfied / extremely satisfied
Total number of dexmedetomidine-related side effects
Total number of dexmedetomidine-related side effects, in particular bradycardia and hypotension
Dexmedetomidine-related side effects
Number and % of patients who experience at least one dexmedetomidine-related side effect
Opioid-related side effect
Number and % of patients who experience at least one opioid-related side effect

Full Information

First Posted
May 12, 2022
Last Updated
March 31, 2023
Sponsor
Hôpital du Valais
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1. Study Identification

Unique Protocol Identification Number
NCT05389852
Brief Title
Analgesic Efficacy of Intravenous Dexmedetomidine for Supraclavicular Plexus Block
Acronym
TwoDex
Official Title
Analgesic Efficacy of Intravenous Dexmedetomidine for Supraclavicular Plexus Block: a Randomized Double-blinded Placebo Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital du Valais

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of the study is to compare the duration of analgesia in patients undergoing forearm or hand surgery with a supraclavicular brachial plexus block, who receive either iv dexmedetomidine or placebo.
Detailed Description
Most surgical interventions on the forearm and the hand in Valais Hospital are performed under regional anesthesia. This ensures intraoperative patient comfort and reduces pain during the first 6 to 12 postoperative hours. A very common strategy to provide anesthesia of the arm is to inject local anesthetics in the region over the clavicle around the brachial plexus. This "supraclavicular brachial plexus block" is routinely performed in Valais Hospital and is always done under ultrasound guidance. A drawback of locoregional anesthesia is the recurrence of pain once the effect of the block wears off after approximately 6 to 8 hours. This phenomenon is called rebound pain. It and can be very severe and debilitating, can significantly impact postoperative recovery and may also preclude ambulatory surgery as well as early mobilization and physiotherapy. Therefore, strategies that prolong the analgesic effect of locoregional anesthesia are warranted. Dexmedetomidine is a selective α2-adrenoceptor agonists with sedative and analgesic properties. It has been shown to prolong the analgesic duration of local anesthetics when administered intravenously. However, the association of dexmedetomidine with long-acting local anesthetics for supraclavicular brachial plexus block has not been systematically investigated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery
Keywords
locoregional anesthesia, postoperative analgesia, hand surgery, dexmedetomidine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Patients undergoing forearm or hand surgery under supraclavicular brachial plexus block, receiving either additional intravenous dexmedetomidine or placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
dexmedetomidine or placebo prepared by Lausanne University Hospital Pharmacy
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intravenous dexmedetomidine
Arm Type
Active Comparator
Arm Description
Patients will receive intravenous dexmedetomidine 1 mcg/kg just after the supraclavicular brachial plexus block is completed
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive intravenous placebo (normal saline) just after the supraclavicular brachial plexus is completed
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Dexdor
Intervention Description
After completion of supraclavicular brachial plexus block patients will receive intravenous dexmedetomidine 1 mcg/kg
Primary Outcome Measure Information:
Title
duration of analgesia
Description
time in minutes from end of injection of local anesthetic till first analgesic request
Time Frame
24 hours on day of surgery
Secondary Outcome Measure Information:
Title
Duration of motor block
Description
time in minutes from completion of locoregional anesthesia and the moment the patient can again mobilize the arm
Time Frame
24 hours on day of surgery
Title
Duration of sensory block
Description
time in minutes from completion of locoregional anesthesia and the moment the patient regains sensation of the arm
Time Frame
24 hours on day of surgery
Title
Pain scores at rest
Description
Pain scores at rest on numeric scale, 0=no pain at all to 10=worst pain imaginable
Time Frame
4, 24, 48 hours postoperatively
Title
Pain scores on movement
Description
Pain scores on movement, on numeric scale, 0=no pain at all to 10=worst pain imaginable
Time Frame
4, 24, 48 hours postoperatively
Title
Cumulative amount of opiate analgesic medication consumed
Description
in intravenous morphine equivalents (mg)
Time Frame
24, 48 hours postoperatively
Title
Patient satisfaction
Description
on 4 point Likert scale: dissatisfied / neutral / satisfied / extremely satisfied
Time Frame
7 days postoperatively
Title
Total number of dexmedetomidine-related side effects
Description
Total number of dexmedetomidine-related side effects, in particular bradycardia and hypotension
Time Frame
24 hours postoperatively
Title
Dexmedetomidine-related side effects
Description
Number and % of patients who experience at least one dexmedetomidine-related side effect
Time Frame
24 hours postoperatively
Title
Opioid-related side effect
Description
Number and % of patients who experience at least one opioid-related side effect
Time Frame
24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing elbow, forearm or hand surgery under supraclavicular brachial plexus block Patients who are ASA physical status I-III Exclusion criteria Patient refusal ASA physical status IV History of hypersensitivity or intolerance to dexmedetomidine History of hypersensitivity or intolerance to dexamethasone History of hypersensitivity or intolerance to local anesthetics History of recent (< 1 year) cerebrovascular insult Second or third degree heart block Uncontrolled hypotension Conditions contraindicating supraclavicular brachial plexus block: neurological deficit or neuropathy of the arm, severe hepatic dysfunction (Child B and C), coagulopathy, malignancy or infection in the area above the clavicle Chronic opioid use Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sina Grape, MD, MBA
Phone
0041276038759
Email
sina.grape@hopitalvs.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Albrecht, Prof
Phone
0041 21 314 2007
Email
eric.albrecht@chuv.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sina Grape, MD, MBA
Organizational Affiliation
Valais Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital du Valais
City
Sion
ZIP/Postal Code
1950
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sina Grape, MD
Phone
0041276038756
Email
sina.grape@hopitalvs.ch
First Name & Middle Initial & Last Name & Degree
Eric Albrecht, MD
Phone
0041763281145
Email
eric.albrecht@chuv.ch
First Name & Middle Initial & Last Name & Degree
Eric Albrecht, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Analgesic Efficacy of Intravenous Dexmedetomidine for Supraclavicular Plexus Block

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