Pharmacokinetic Analysis of Bupivacaine in the Presence and Absence of Perineural Dexamethasone in Axillary Blockade

October 13, 2023 updated by: Daniela Bravo Advis, University of Chile

Pharmacokinetic Analysis of Bupivacaine in the Presence and Absence of Perineural Dexamethasone in Axillary Brachial Plexus Blockade for Distal Forearm and Hand Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Metropolitan
      • Santiago, Metropolitan, Chile
        • Hospital Clinico Universidad de Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Perineural Bupivacaine
Bupivacaine without Dexamethasone in axillary brachial plexus blockade
Drug: Bupivacaine Hydrochloride
Patients will receive a total volume of 30 ml of bupivacaine 0.5% in an axillary block with a double puncture.
Experimental: Perineural Bupivacaine plus Dexamethasone
Bupivacaine with Dexamethasone in axillary brachial plexus blockade
Drug: Bupivacaine Hydrochloride with Dexamethasone
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum plasma concentration (Cmax) of bupivacaine
Time Frame: 0 to 90 minutes after the ending time of local anesthetic injection
Maximum plasmatic level of bupivacaine
0 to 90 minutes after the ending time of local anesthetic injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensory and motor block score
Time Frame: 30 minutes after the ending time of local anesthetic injection

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.
30 minutes after the ending time of local anesthetic injection
Plasmatic concentration of bupivacaine at 15 minutes
Time Frame: 15 minutes after the ending time of local anesthetic injection
Plasmatic level of bupivacaine 15 minutes after local anesthetic injection (ng/ml)
15 minutes after the ending time of local anesthetic injection
Plasmatic concentration of bupivacaine at 30 minutes
Time Frame: 30 minutes after the ending time of local anesthetic injection
Plasmatic level of bupivacaine 30 minutes after local anesthetic injection (ng/ml)
30 minutes after the ending time of local anesthetic injection
Plasmatic concentration of bupivacaine at 45 minutes
Time Frame: 45 minutes after the ending time of local anesthetic injection
Plasmatic level of bupivacaine 45 minutes after local anesthetic injection (ng/ml)
45 minutes after the ending time of local anesthetic injection
Plasmatic concentration of bupivacaine at 60 minutes
Time Frame: 60 minutes after the ending time of local anesthetic injection
Plasmatic level of bupivacaine 60 minutes after local anesthetic injection (ng/ml)
60 minutes after the ending time of local anesthetic injection
Plasmatic concentration of bupivacaine at 90 minutes
Time Frame: 90 minutes after the ending time of local anesthetic injection
Plasmatic level of bupivacaine 90 minutes after local anesthetic injection (ng/ml)
90 minutes after the ending time of local anesthetic injection
Time to obtain the maximum plasma concentration of bupivacaine (Tmax)
Time Frame: 0 to 90 minutes after the ending time of local anesthetic injection
Time in minutes in which the maximum plasmatic level of bupivacaine is reached
0 to 90 minutes after the ending time of local anesthetic injection
Area under the curve of plasma concentration versus time at 90 minutes (AUC90)
Time Frame: 0 to 90 minutes after the ending time of local anesthetic injection
Area under the curve at 90 minutes
0 to 90 minutes after the ending time of local anesthetic injection
Block onset time
Time Frame: 30 minutes after the ending time of local anesthetic injection
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.
30 minutes after the ending time of local anesthetic injection
Incidence of successful block
Time Frame: 30 minutes after the ending time of local anesthetic injection
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
30 minutes after the ending time of local anesthetic injection
Motor block duration
Time Frame: 48 hours after the ending time of local anesthetic injection
The elapsed period in minutes between the ending time of the local anesthetic injection and the time of return of hand and fingers movement.
48 hours after the ending time of local anesthetic injection
Sensory block duration
Time Frame: 48 hours after the ending time of local anesthetic injection
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
48 hours after the ending time of local anesthetic injection
Analgesic block duration
Time Frame: 48 hours after the ending time of local anesthetic injection
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
48 hours after the ending time of local anesthetic injection
Intensity of pain during block procedure
Time Frame: During the execution of the nerve blockade
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.
During the execution of the nerve blockade
Block performance time
Time Frame: From the skin anesthesia to the end of local anesthetic injection
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)
From the skin anesthesia to the end of local anesthetic injection
Incidence of nerve block side effects
Time Frame: From the skin anesthesia to the end of local anesthetic injection
Determined by the presence of paresthesia, local anesthetic systemic toxicity, vascular puncture after the block.
From the skin anesthesia to the end of local anesthetic injection
Persistent neurologic deficit
Time Frame: 7 days after surgery
Presence of persistent sensory or motor postoperative deficit.
7 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2022

Primary Completion (Actual)

April 17, 2023

Study Completion (Actual)

April 24, 2023

Study Registration Dates

First Submitted

April 28, 2022

First Submitted That Met QC Criteria

April 28, 2022

First Posted (Actual)

May 4, 2022

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 13, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OAIC 1249/22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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