Bupivacaine Versus Bupivacaine Plus Lidocaine in Infraclavicular Block

Hospital de San Carlos Dr. Benicio Arzola Medina

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Pain, Acute; Analgesia

Treatments: Drug: Bupivacaine-Lidocaine; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05834023

CEC-HCHM 05-2023

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Bupivacaine 0.25% plus Lidocaine 1%

Active Comparator group

Description:

Infraclavicular block with Bupivacaine and Lidocaine

Treatment:

Drug: Bupivacaine-Lidocaine

Bupivacaine 0.5%

Experimental group

Description:

Infraclavicular block with Bupivacaine

Treatment:

Drug: Bupivacaine