Back to resultsPharmacokinetic Analysis of Bupivacaine in the Presence and Absence of Perineural Dexamethasone in Axillary Blockade
Primary Purpose
Analgesia, Acute Pain, Upper Extremity Injury
Status
Completed
Phase
Phase 4
Locations
Chile
Study Type
Interventional
Intervention
Bupivacaine Hydrochloride
Bupivacaine Hydrochloride with Dexamethasone
Sponsored by
About this trial
This is an interventional basic science trial for Analgesia focused on measuring Dexamethasone, Nerve Block, Adjuvant, Pharmacokinetic Analysis
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologists classification 1-2
- Real weight between 80 and 100 kg
- Body mass index between 20 and 30
Exclusion Criteria:
- Adults who are not capable of giving their own consent
- Medical history or physical findings of pre-existing neuropathy
- Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
- Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
- Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
- Allergy to local anesthetics (LAs)
- Pregnancy
- Previous surgery in the axillary region of the surgical side
Sites / Locations
- Hospital Clínico Universidad de Chile
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Perineural Bupivacaine
Perineural Bupivacaine plus Dexamethasone
Arm Description
Bupivacaine without Dexamethasone in axillary brachial plexus blockade
Bupivacaine with Dexamethasone in axillary brachial plexus blockade
Outcomes
Primary Outcome Measures
Maximum plasma concentration (Cmax) of bupivacaine
Maximum plasmatic level of bupivacaine
Secondary Outcome Measures
Plasmatic concentration of bupivacaine at 15 minutes
Plasmatic level of bupivacaine 15 minutes after local anesthetic injection (ng/ml)
Plasmatic concentration of bupivacaine at 30 minutes
Plasmatic level of bupivacaine 30 minutes after local anesthetic injection (ng/ml)
Plasmatic concentration of bupivacaine at 45 minutes
Plasmatic level of bupivacaine 45 minutes after local anesthetic injection (ng/ml)
Plasmatic concentration of bupivacaine at 60 minutes
Plasmatic level of bupivacaine 60 minutes after local anesthetic injection (ng/ml)
Plasmatic concentration of bupivacaine at 90 minutes
Plasmatic level of bupivacaine 90 minutes after local anesthetic injection (ng/ml)
Time to obtain the maximum plasma concentration of bupivacaine (Tmax)
Time in minutes in which the maximum plasmatic level of bupivacaine is reached
Area under the curve of plasma concentration versus time at 90 minutes (AUC90)
Area under the curve at 90 minutes
Sensory and motor block score
The sensorimotor block will be assessed every 5 minutes until 30 minutes after the end of local anesthetic injection using a 16-point composite score evaluating sensory and motor block of musculocutaneous, medium, radial, and ulnar nerves.
Sensation will be assessed with ice in each nerve territory with a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, the patient can feel touch but not cold; 2= anesthetic block, the patient cannot feel cold or touch.
The motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis.
Successful blocks at 30 minutes correlate with a final score ( sum of all individual sensory and motor scores) of at least 14 points out of 16.
Block onset time
Time required to reach a minimal sensorimotor composite score of 14 points out of a maximum of 16 points. The sensorimotor score is described in outcome 9.
Incidence of successful block
Percentage of blocks with a minimal sensorimotor composite score of 14 points out of a maximum of 16 points at 30 minutes after the injection
Motor block duration
The elapsed period in minutes between the ending time of the local anesthetic injection and the time of return of hand and fingers movement.
Sensory block duration
The elapsed period in minutes between the ending time of the local anesthetic injection and the time of the return of hand and fingers sensation
Analgesic block duration
The elapsed period in minutes between the ending time of the local anesthetic injection and the time of the first sensation of pain in the surgical area
Intensity of pain during block procedure
Evaluated with the Numeric Rating Scale for Pain. This scale is graduated from 0 to 10 points. A 0-point score represents the absence of pain, and a 10-points score represents the worst imaginable pain. Patients will be asked to rate their pain verbally with this scale. The blinded assessor will register the score reported.
Block performance time
Sum of: 1- the acquisition time of the ultrasonographic image. and 2- the time to perform the block itself (from the skin anesthesia to the end of local anesthetic injection)
Incidence of nerve block side effects
Determined by the presence of paresthesia, local anesthetic systemic toxicity, vascular puncture after the block.
Persistent neurologic deficit
Presence of persistent sensory or motor postoperative deficit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05359731
Brief Title
Pharmacokinetic Analysis of Bupivacaine in the Presence and Absence of Perineural Dexamethasone in Axillary Blockade
Official Title
Pharmacokinetic Analysis of Bupivacaine in the Presence and Absence of Perineural Dexamethasone in Axillary Brachial Plexus Blockade for Distal Forearm and Hand Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 28, 2022 (Actual)
Primary Completion Date
April 17, 2023 (Actual)
Study Completion Date
April 24, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile
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 investigators will conduct a prospective, randomized, double-blinded study using an axillary brachial plexus block in patients undergoing elective surgery of the distal forearm and hand to characterize and describe the pharmacokinetics of bupivacaine associated with perineural dexamethasone.
The pharmacokinetic analysis will be performed by measuring bupivacaine plasma levels at different time intervals after the blockade (15, 30, 45, 60, and 90 minutes), allowing comparison between 2 different groups: Bupivacaine (B) and Bupivacaine-dexamethasone (BD).
Thus, the hypothesis is that plasma levels of bupivacaine during the first 90 minutes after a blockade are lower in the presence of perineural dexamethasone, suggesting a decrease, at least initially, in systemic absorption from the injection site.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Acute Pain, Upper Extremity Injury
Keywords
Dexamethasone, Nerve Block, Adjuvant, Pharmacokinetic Analysis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Perineural Bupivacaine
Arm Type
Active Comparator
Arm Description
Bupivacaine without Dexamethasone in axillary brachial plexus blockade
Arm Title
Perineural Bupivacaine plus Dexamethasone
Arm Type
Experimental
Arm Description
Bupivacaine with Dexamethasone in axillary brachial plexus blockade
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Intervention Description
Patients will receive a total volume of 30 ml of bupivacaine 0.5% in an axillary block with a double puncture.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride with Dexamethasone
Intervention Description
Patients will receive a total volume of 30 ml of bupivacaine 0.5% with Dexamethasone 4 mg in an axillary block with a double puncture.
Primary Outcome Measure Information:
Title
Maximum plasma concentration (Cmax) of bupivacaine
Description
Maximum plasmatic level of bupivacaine
Time Frame
0 to 90 minutes after the ending time of local anesthetic injection
Secondary Outcome Measure Information:
Title
Plasmatic concentration of bupivacaine at 15 minutes
Description
Plasmatic level of bupivacaine 15 minutes after local anesthetic injection (ng/ml)
Time Frame
15 minutes after the ending time of local anesthetic injection
Title
Plasmatic concentration of bupivacaine at 30 minutes
Description
Plasmatic level of bupivacaine 30 minutes after local anesthetic injection (ng/ml)
Time Frame
30 minutes after the ending time of local anesthetic injection
Title
Plasmatic concentration of bupivacaine at 45 minutes
Description
Plasmatic level of bupivacaine 45 minutes after local anesthetic injection (ng/ml)
Time Frame
45 minutes after the ending time of local anesthetic injection
Title
Plasmatic concentration of bupivacaine at 60 minutes
Description
Plasmatic level of bupivacaine 60 minutes after local anesthetic injection (ng/ml)
Time Frame
60 minutes after the ending time of local anesthetic injection
Title
Plasmatic concentration of bupivacaine at 90 minutes
Description
Plasmatic level of bupivacaine 90 minutes after local anesthetic injection (ng/ml)
Time Frame
90 minutes after the ending time of local anesthetic injection
Title
Time to obtain the maximum plasma concentration of bupivacaine (Tmax)
Description
Time in minutes in which the maximum plasmatic level of bupivacaine is reached
Time Frame
0 to 90 minutes after the ending time of local anesthetic injection
Title
Area under the curve of plasma concentration versus time at 90 minutes (AUC90)
Description
Area under the curve at 90 minutes
Time Frame
0 to 90 minutes after the ending time of local anesthetic injection
Title
Sensory and motor block score
Description
The sensorimotor block will be assessed every 5 minutes until 30 minutes after the end of local anesthetic injection using a 16-point composite score evaluating sensory and motor block of musculocutaneous, medium, radial, and ulnar nerves.
Sensation will be assessed with ice in each nerve territory with a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, the patient can feel touch but not cold; 2= anesthetic block, the patient cannot feel cold or touch.
The motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis.
Successful blocks at 30 minutes correlate with a final score ( sum of all individual sensory and motor scores) of at least 14 points out of 16.
Time Frame
30 minutes after the ending time of local anesthetic injection
Title
Block onset time
Description
Time required to reach a minimal sensorimotor composite score of 14 points out of a maximum of 16 points. The sensorimotor score is described in outcome 9.
Time Frame
30 minutes after the ending time of local anesthetic injection
Title
Incidence of successful block
Description
Percentage of blocks with a minimal sensorimotor composite score of 14 points out of a maximum of 16 points at 30 minutes after the injection
Time Frame
30 minutes after the ending time of local anesthetic injection
Title
Motor block duration
Description
The elapsed period in minutes between the ending time of the local anesthetic injection and the time of return of hand and fingers movement.
Time Frame
48 hours after the ending time of local anesthetic injection
Title
Sensory block duration
Description
The elapsed period in minutes between the ending time of the local anesthetic injection and the time of the return of hand and fingers sensation
Time Frame
48 hours after the ending time of local anesthetic injection
Title
Analgesic block duration
Description
The elapsed period in minutes between the ending time of the local anesthetic injection and the time of the first sensation of pain in the surgical area
Time Frame
48 hours after the ending time of local anesthetic injection
Title
Intensity of pain during block procedure
Description
Evaluated with the Numeric Rating Scale for Pain. This scale is graduated from 0 to 10 points. A 0-point score represents the absence of pain, and a 10-points score represents the worst imaginable pain. Patients will be asked to rate their pain verbally with this scale. The blinded assessor will register the score reported.
Time Frame
During the execution of the nerve blockade
Title
Block performance time
Description
Sum of: 1- the acquisition time of the ultrasonographic image. and 2- the time to perform the block itself (from the skin anesthesia to the end of local anesthetic injection)
Time Frame
From the skin anesthesia to the end of local anesthetic injection
Title
Incidence of nerve block side effects
Description
Determined by the presence of paresthesia, local anesthetic systemic toxicity, vascular puncture after the block.
Time Frame
From the skin anesthesia to the end of local anesthetic injection
Title
Persistent neurologic deficit
Description
Presence of persistent sensory or motor postoperative deficit.
Time Frame
7 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists classification 1-2
Real weight between 80 and 100 kg
Body mass index between 20 and 30
Exclusion Criteria:
Adults who are not capable of giving their own consent
Medical history or physical findings of pre-existing neuropathy
Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
Allergy to local anesthetics (LAs)
Pregnancy
Previous surgery in the axillary region of the surgical side
Facility Information:
Facility Name
Hospital Clínico Universidad de Chile
City
Santiago
State/Province
Metropolitan
Country
Chile
12. IPD Sharing Statement
Citations:
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33456903
Citation
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Pharmacokinetic Analysis of Bupivacaine in the Presence and Absence of Perineural Dexamethasone in Axillary Blockade
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