Bupivacaine Versus Bupivacaine Plus Lidocaine in Infraclavicular Block

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain, Acute, Postoperative Pain, Analgesia

Intervention / Treatment
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* Drug: Bupivacaine-Lidocaine
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine 0.25% plus Lidocaine 1%<br>Infraclavicular block with Bupivacaine and Lidocaine | Drug: Bupivacaine-Lidocaine<br>* Infraclavicular block with 35 ml of the following anesthetic solution: Bupivacaine 0.25% + Lidocaine 1% + dexamethasone 4 mg + epinephrine 5 mcg/ml<br>|
| Experimental: Bupivacaine 0.5%<br>Infraclavicular block with Bupivacaine | Drug: Bupivacaine<br>* Infraclavicular block with 35 ml of the following anesthetic solution: Bupivacaine 0.5% + dexamethasone 4 mg + epinephrine 5 mcg/ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor block duration | The time interval in minutes between the end of the local anesthetic injection and the return of hand mobility. | 0 - 48 hours after block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory block duration | The time interval in minutes between the end of the local anesthetic injection and the return of hand sensation. | 0 - 48 hours after block | 
| Analgesic block duration | The time interval in minutes between the end of the local anesthetic injection and the first sensation of pain in the surgical area. | 0 - 48 hours after block | 
| Sensory and motor block score | 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. | 0 - 60 minutes after block | 
| Block onset time | 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. | 0 - 60 minutes after block | 
| Incidence of successful 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. | 0 - 60 minutes after block | 
| Incidence of failed block | Patients with a sensorimotor score of 13 points or less. The sensorimotor score is described in Outcome 4. | 0 - 60 minutes after block | 
| Incidence of anesthetic block | Ability to proceed with the surgery without general anesthesia, rescue blocks, or local anesthesia infiltration by the surgeon. | 60 to 120 minutes after the ending time of local anesthetic injection | 
| Procedural pain | 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. | Immediately after nerve block | 
| Image time | The time interval in seconds between the probe placement and the acquisition of the final ultrasonographic image. | 2 hours before surgery | 
| Needle time | The time interval in seconds between the skin infiltration and the end of local anesthetic injection | 2 hours before surgery | 
| Block performance time | Sum of image and needle time | 2 hours before surgery | 
| Number of patients requiring general anesthesia | Patients who need general anesthesia to proceed with the surgery | 60 to 120 minutes after the ending time of local anesthetic injection | 
| Diaphragmatic function | Diaphragmatic excursion in millimeters evaluated by ultrasound in three different times: pre-block, 60 minutes after block, and at the end of the surgery | From arrival to the pre-anesthesia unit to the end of surgery | 
| Rate of diaphragmatic paresis | 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. | From 60 minutes after block to the end of the surgery | 
| Rate of diaphragmatic paralysis | 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. | From 60 minutes after block to the end of the surgery | 
| Incidence of rebound pain | Severe pain (NRS ≥ 7) in the surgical area within 24 hours after the block wears off. | 24 hours after the block wears off | 
| Incidence of nerve block side effects | The presence of Horner syndrome, paresthesia, vascular puncture, hematoma, or local anesthetic systemic toxicity after the nerve block. | From skin anesthesia to 60 minutes after the nerve block | 
| Postoperative complications | Presence of persistent paresthesia, numbness, or motor deficit in the postoperative period. | 7 days after surgery | 
| Duration of surgery | Time in minutes between skin incision and closure. | 3 hours after skin incision | 
| Pain score in the post-anesthesia care unit (PACU) | 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. | 3 hours after the end of the surgery | 
| Length of PACU stay | The time interval in minutes between PACU arrival to readiness to discharge | 3 hours after the end of the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bupivacaine, Lidocaine, Nerve Block, Infraclavicular Block, Upper Extremity Surgery