Dexametasone Versus Dexametasone Plus Dexmedetomidine in Nerve Blocks
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Analgesia
- Pain Acute
- Upper Extremity Injury
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: blinded-randomized controlled trialMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: 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.Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
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 rout...
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 1.0%-bupivacaine 0.25% with epinephrine 5 µ/mL. 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.
Tracking Information
- NCT #
- NCT04875039
- Collaborators
- Not Provided
- Investigators
- Not Provided