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COMPLETED
NCT07907666
PHASE4

Ropivacaine Alone Versus Ropivacaine Plus Lidocaine With or Without Epinephrine for Supraclavicular Brachial Plexus Block in Upper Limb Orthopedic Surgery

Sponsor: Instituto Mexicano del Seguro Social

View on ClinicalTrials.gov

Summary

This randomized controlled trial compared three local anesthetic solutions for ultrasound-guided supraclavicular brachial plexus block in adults aged 18 to 59 years undergoing upper limb orthopedic and trauma surgery at a general hospital of the Mexican Social Security Institute (IMSS) in Aguascalientes, Mexico. Participants were randomly assigned to receive 30 mL of ropivacaine 0.375% alone, ropivacaine 0.375% plus lidocaine 1%, or ropivacaine 0.375% plus lidocaine 1% with epinephrine. The main question was whether adding lidocaine, with or without epinephrine, to ropivacaine improves postoperative analgesia. Pain intensity (0 to 10 Numeric Rating Scale) at 6 hours after surgery was the primary outcome. Secondary outcomes were pain at 0 and 12 hours, need for rescue analgesia, analgesic and opioid consumption, motor block (modified Bromage scale) and adverse events during the first 12 postoperative hours. Block onset time was also recorded.

Official title: Analgesic Effectiveness of Two Combinations of Local Anesthetics in Brachial Plexus Block in Patients Aged 18 to 59 Years Undergoing Orthopedic and Trauma Surgery at General Hospital of Zone No. 3, IMSS, Aguascalientes: a Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 59 Years

Study Type

INTERVENTIONAL

Enrollment

138

Start Date

2026-03-02

Completion Date

2026-04-17

Last Updated

2026-10-30

Healthy Volunteers

No

Interventions

DRUG

ropivacaine

Ropivacaine 112.5 mg (15 mL of 0.75%) administered perineurally in an ultrasound-guided supraclavicular brachial plexus block, diluted to a total volume of 30 mL.

DRUG

lidocaine

Lidocaine 300 mg (15 mL of 2%) mixed with ropivacaine for perineural administration in the supraclavicular brachial plexus block (final lidocaine concentration 1%).

DRUG

lidocaine with epinephrine

Lidocaine 300 mg with epinephrine 75 micrograms (15 mL of lidocaine 2% with epinephrine) mixed with ropivacaine for perineural administration (final concentrations: lidocaine 1%, epinephrine 2.5 micrograms/mL).

Locations (1)

Hospital General de Zona No. 3, Instituto Mexicano del Seguro Social

Aguascalientes, Aguascalientes, Mexico