Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04875039
Status:
COMPLETED
Last Update Posted:
2022-03-04
First Post:
2021-04-27
Brief Title:
Dexametasone Versus Dexametasone Plus Dexmedetomidine in Nerve Blocks
Sponsor:
University of Chile
Organization:
University of Chile
Study Overview
Official Title:
A Randomized Comparison Between Perineural Dexamethasone and Perineural Mixture of Dexamethasone-Dexmedetomidine as Adjuvants for Ultrasound-Guided Infraclavicular Block
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will compare perineural dexamethasone 2mg and perineural mixture of dexamethasone 2mg plus dexmedetomidine 50mcg DX plus DXD as adjuvants to local anesthetics for ultrasound-guided infraclavicular brachial plexus blocks ICBs The protocol is designed as a superiority trial and hypothesizes that the mixture of both drugs results in longer block duration Furthermore since analgesic and sensory duration can be influenced by the intake of pain medications and surgical trauma to small cutaneous nerves respectively motor block duration was selected as the main outcome to better target the action of both adjuvants on the brachial plexus
Detailed Description:
With the approval of Ethics Committee of the Hospital Clínico Universidad de Chile a total of 50 patients undergoing upper extremity surgery elbow and below will be recruited Recruitment will be carried out by an investigator not involved in patient care in the preoperative clinic or during routine preoperative visits
All ICBs will be supervised by one of the coauthors and conducted preoperatively in an induction room
After skin disinfection and draping the ICB will be performed with a previously described technique In both groups a proven 90 effective volume of 35 mL of local anesthetic solution will be injected As LA solution it will be used a mixture of lidocaine 10-bupivacaine 025 with epinephrine 5 µmL The injectate will be slowly injected through the block needle
Patients will be randomized to receive the study drug either PN 2 mg dexamethasone or a combination of PN 2 mg dexamethasone with 50 ug dexmedetomidine mixed with the above-mentioned LA solution
A research assistant licensed anesthesiologist will prepare the local anesthetic solutions and will add the study drug following the randomization order The operator patient and investigator assessing the block will be blinded to group allocation
The primary outcome will be the duration of the motor block defined as the temporal interval between the end of LA injection through the block needle and the return of movement to the hand and fingers for patients with successful ICBs Patients will be provided with a data sheet and asked to record the time at which motor function returns An investigator blinded to group allocation will collect this data sheet in person inpatients or by phone outpatients on postoperative day 1
All ICBs will be supervised by one of the coauthors and conducted preoperatively in an induction room
After skin disinfection and draping the ICB will be performed with a previously described technique In both groups a proven 90 effective volume of 35 mL of local anesthetic solution will be injected As LA solution it will be used a mixture of lidocaine 10-bupivacaine 025 with epinephrine 5 µmL The injectate will be slowly injected through the block needle
Patients will be randomized to receive the study drug either PN 2 mg dexamethasone or a combination of PN 2 mg dexamethasone with 50 ug dexmedetomidine mixed with the above-mentioned LA solution
A research assistant licensed anesthesiologist will prepare the local anesthetic solutions and will add the study drug following the randomization order The operator patient and investigator assessing the block will be blinded to group allocation
The primary outcome will be the duration of the motor block defined as the temporal interval between the end of LA injection through the block needle and the return of movement to the hand and fingers for patients with successful ICBs Patients will be provided with a data sheet and asked to record the time at which motor function returns An investigator blinded to group allocation will collect this data sheet in person inpatients or by phone outpatients on postoperative day 1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None