Skip to main content
OpenTrials
Completed

NCT Number: NCT05834023

Bupivacaine Versus Bupivacaine Plus Lidocaine in Infraclavicular Block

In this study, the investigators will compare two different anesthetic solutions in the infraclavicular block in patients having forearm, wrist, and hand surgery. The solutions will be bupivacaine 0.5% versus bupivacaine 0.25% plus lidocaine 1%, both associated with epinephrine 5 mcg/ml and dexamethasone 4 mg.

The main objective of this investigation is to demonstrate that using higher concentrations of bupivacaine alone results in a significant block duration increase compared with the mixture of bupivacaine and lidocaine.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain, Acute Acute Pain Agnosia Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital de San Carlos Dr. Benicio Arzola Medina

San Carlos, Región de Ñuble, Chile

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 18 and 80 years
  • American Society of Anesthesiologists classification 1-3
  • Surgery of the forearm, wrist, and hand
  • Weight ≥ 80 kilograms

Exclusion criteria

  • Adults who are unable to give their consent
  • Infection in the injection site (infraclavicular region)
  • Pre-existing neuropathy (assessed by history and physical examination)
  • Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work, i.e., platelets ≤ 100, International Normalized Ratio ≥ 1.4)
  • Renal failure (assessed by history and physical examination and if deemed clinically necessary, by blood work, i.e., creatinine ≥ 1.2)
  • Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work, i.e., transaminases ≥ 100)
  • Allergy to local anesthetics (LAs)
  • Pregnancy or breastfeeding
  • Prior surgery in the infraclavicular region
  • Chronic pain syndromes requiring opioid intake at home

Treatment and study plan

Bupivacaine-Lidocaine

Drug

Infraclavicular block with 35 ml of the following anesthetic solution: Bupivacaine 0.25% + Lidocaine 1% + dexamethasone 4 mg + epinephrine 5 mcg/ml

Bupivacaine

Drug

Infraclavicular block with 35 ml of the following anesthetic solution: Bupivacaine 0.5% + dexamethasone 4 mg + epinephrine 5 mcg/ml

Primary outcomes

  1. Motor block duration

    Time frame: 0 - 48 hours after block

    The time interval in minutes between the end of the local anesthetic injection and the return of hand mobility.

Secondary outcomes

  1. Sensory block duration

    Time frame: 0 - 48 hours after block

    The time interval in minutes between the end of the local anesthetic injection and the return of hand sensation.

  2. Analgesic block duration

    Time frame: 0 - 48 hours after block

    The time interval in minutes between the end of the local anesthetic injection and the first sensation of pain in the surgical area.

  3. Sensory and motor block score

    Time frame: 0 - 60 minutes after block

    The sensorimotor block will be assessed every 5 minutes until 60 minutes after the end of local anesthetic injection using a 16-point composite score evaluating sensory and motor block of musculocutaneous, median, radial, and ulnar nerves.

    Sensation will be assessed with a pinprick test in each nerve territory with a 0 to 2-point scale. 0= no block, patients can feel a pin prick; 1= analgesic block, the patient can feel touch but not pinprick; 2= anesthetic block, the patient cannot feel pinprick 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.

  4. Block onset time

    Time frame: 0 - 60 minutes after block

    The time interval in minutes between the end of the local anesthetic injection and a minimal sensorimotor composite score of 14 out of 16 points.

    The sensorimotor score is described in Outcome 4.

  5. Incidence of successful block

    Time frame: 0 - 60 minutes after block

    Patients with a minimal sensorimotor score of 14 out of 16 points, with at least 7 points in the sensitive score. The sensorimotor score is described in Outcome 4.

  6. Incidence of failed block

    Time frame: 0 - 60 minutes after block

    Patients with a sensorimotor score of 13 points or less. The sensorimotor score is described in Outcome 4.

  7. Incidence of anesthetic block

    Time frame: 60 to 120 minutes after the ending time of local anesthetic injection

    Ability to proceed with the surgery without general anesthesia, rescue blocks, or local anesthesia infiltration by the surgeon.

  8. Procedural pain

    Time frame: Immediately after nerve block

    Pain related to the nerve block according to 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-point score means the worst imaginable pain.

  9. Image time

    Time frame: 2 hours before surgery

    The time interval in seconds between the probe placement and the acquisition of the final ultrasonographic image.

  10. Needle time

    Time frame: 2 hours before surgery

    The time interval in seconds between the skin infiltration and the end of local anesthetic injection

  11. Block performance time

    Time frame: 2 hours before surgery

    Sum of image and needle time

  12. Number of patients requiring general anesthesia

    Time frame: 60 to 120 minutes after the ending time of local anesthetic injection

    Patients who need general anesthesia to proceed with the surgery

  13. Diaphragmatic function

    Time frame: From arrival to the pre-anesthesia unit to the end of surgery

    Diaphragmatic excursion in millimeters evaluated by ultrasound in three different times: pre-block, 60 minutes after block, and at the end of the surgery

  14. Rate of diaphragmatic paresis

    Time frame: From 60 minutes after block to the end of the surgery

    Patients with decreased diaphragmatic excursion by 25% to 75% compared with the basal function 60 minutes after the block or at the end of the surgery.

  15. Rate of diaphragmatic paralysis

    Time frame: From 60 minutes after block to the end of the surgery

    Patients with decreased diaphragmatic excursion greater than 75% compared with the basal function, absence of diaphragmatic movement, or paradoxical movement 60 minutes after the block or at the end of the surgery.

  16. Incidence of rebound pain

    Time frame: 24 hours after the block wears off

    Severe pain (NRS ≥ 7) in the surgical area within 24 hours after the block wears off.

  17. Incidence of nerve block side effects

    Time frame: From skin anesthesia to 60 minutes after the nerve block

    The presence of Horner syndrome, paresthesia, vascular puncture, hematoma, or local anesthetic systemic toxicity after the nerve block.

  18. Postoperative complications

    Time frame: 7 days after surgery

    Presence of persistent paresthesia, numbness, or motor deficit in the postoperative period.

  19. Duration of surgery

    Time frame: 3 hours after skin incision

    Time in minutes between skin incision and closure.

  20. Pain score in the post-anesthesia care unit (PACU)

    Time frame: 3 hours after the end of the surgery

    Highest pain reported by the patient in the PACU according to 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-point score means the worst imaginable pain.

  21. Length of PACU stay

    Time frame: 3 hours after the end of the surgery

    The time interval in minutes between PACU arrival to readiness to discharge

Sponsors and collaborators

Lead sponsor

Hospital de San Carlos Dr. Benicio Arzola Medina

Other

Registry information

Official study title

Comparison Between Bupivacaine 0.5% Versus Bupivacaine 0.25% Plus Lidocaine 1% in Ultrasound-guided Infraclavicular Block: a Prospective Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Apr 27, 2023
Registry last updated
Jan 17, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.