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Completed

NCT Number: NCT05359731

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

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.

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Key information

Conditions

Analgesia Acute Pain Agnosia Arm Injuries Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Upper Extremity Injury Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clínico Universidad de Chile

Santiago, Metropolitan, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine Hydrochloride

Drug

Patients will receive a total volume of 30 ml of bupivacaine 0.5% in an axillary block with a double puncture.

Bupivacaine Hydrochloride with Dexamethasone

Drug

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 outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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

  7. 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

  8. 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.

  9. 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.

  10. 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

  11. 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.

  12. 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

  13. 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

  14. 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.

  15. 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)

  16. 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.

  17. Persistent neurologic deficit

    Time frame: 7 days after surgery

    Presence of persistent sensory or motor postoperative deficit.

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 4, 2022
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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