Skip to content

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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07907666
Enrollment
138
Registered
2026-10-30
Start date
2026-03-02
Completion date
2026-04-17
Last updated
2026-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Upper Extremity Fracture, Anesthesia, Conduction

Keywords

Brachial Plexus Block, Supraclavicular Block, Ropivacaine, Lidocaine, Epinephrine, Local Anesthetic Mixture, Regional Anesthesia, Postoperative Analgesia, Orthopedic Surgery

Brief 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.

Detailed description

Background. Mixing a fast-onset local anesthetic with a long-acting agent is common practice in peripheral nerve blocks to shorten block onset, but its effect on the quality and duration of analgesia is controversial, and no study had evaluated these mixtures in patients of the Mexican Social Security Institute. Design. Single-center, superiority, randomized controlled trial with three parallel groups (1:1:1 allocation) and blinded outcome assessment, conducted at Hospital General de Zona No. 3, IMSS, Aguascalientes, Mexico, from January 2 to April 16, 2026. The trial was approved by the local research and ethics committees (registration R-2026-101-005) and all participants gave written informed consent. This trial was registered retrospectively, after completion of enrollment. Interventions. All participants received an ultrasound-guided supraclavicular brachial plexus block with a total volume of 30 mL: group C, 15 mL of ropivacaine 0.75% plus 15 mL of sterile water (ropivacaine 0.375%); group L, 15 mL of ropivacaine 0.75% plus 15 mL of lidocaine 2% (ropivacaine 0.375% plus lidocaine 1%); group E, 15 mL of ropivacaine 0.75% plus 15 mL of lidocaine 2% with epinephrine (ropivacaine 0.375% plus lidocaine 1%, final epinephrine concentration 2.5 micrograms/mL, 1:400,000). No perineural adjuvants were used. Blocks were performed by attending anesthesiologists and anesthesiology residents assigned to each operating room according to the department's daily roster. All participants received the institution's standard intraoperative sedation and analgesia (a corticosteroid, a nonsteroidal anti-inflammatory drug, acetaminophen, midazolam and fentanyl), except when a drug was contraindicated. Randomization and blinding. The principal investigator generated the allocation sequence in Excel for folios 1 to 138. Allocation was concealed in sealed envelopes identified by folio number, kept by the thesis investigator together with the study syringes and opened immediately before the block. Outcomes were assessed by the attending anesthesiologists and residents in charge of each participant, who were unaware of group allocation. Outcomes. Pain intensity was measured with the 0 to 10 Numeric Rating Scale and motor block with the modified Bromage scale for the upper limb (0 = full movement, 3 = complete motor block) at 0, 6 and 12 hours after the end of surgery; rescue analgesics, opioid use and adverse events were recorded at the same time points. Block onset time was marked on the monitor from local anesthetic administration to onset of anesthesia and recorded in the anesthesia record. Withdrawal criteria. Withdrawal of consent, failed block (need for general anesthesia or additional intraoperative analgesia attributable to block failure), discharge before 6 postoperative hours, and block-related complications (puncture-site hematoma, pneumothorax, local anesthetic systemic toxicity, persistent neurological deficit or allergic reaction). Sample size and analysis. A sample of 138 participants (46 per group) was calculated with G\*Power (alpha 0.05, power 0.80, effect size d = 0.5). Analysis followed the intention-to-treat principle. Groups were compared with the Kruskal-Wallis test or one-way ANOVA with Bonferroni-corrected pairwise comparisons, and with the chi-square or Fisher-Freeman-Halton tests for categorical variables; effect estimates are reported with 95% confidence intervals. A p value below 0.05 was considered significant.

Interventions

DRUGropivacaine

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.

DRUGlidocaine

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

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).

Sponsors

Instituto Mexicano del Seguro Social
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Single masking (outcomes assessor). The allocation sequence was generated by the principal investigator, and the sealed envelopes and study syringes were kept by the thesis investigator, who opened each envelope immediately before the block. Outcomes (latency, motor block by the Bromage scale, postoperative pain by the 0-10 numeric rating scale, duration of analgesia and need for rescue analgesia) were assessed and recorded by the attending anesthesiologists and anesthesiology residents in charge of each participant, who were assigned to operating rooms by a daily schedule set by the department of anesthesiology independently of the study and were unaware of group allocation. Participants were not formally masked, and the investigators were aware of the allocation.

Intervention model description

Three-arm, parallel-group randomized controlled trial with 1:1:1 allocation. Adults aged 18 to 59 years scheduled for upper limb orthopedic or trauma surgery under ultrasound-guided supraclavicular brachial plexus block were randomly assigned to one of three local anesthetic mixtures, all in a total volume of 30 mL: ropivacaine 0.375% alone (Group C, active comparator), ropivacaine 0.375% plus lidocaine 1% (Group L), or ropivacaine 0.375% plus lidocaine 1% with epinephrine 2.5 micrograms/mL (Group E). The principal investigator generated the allocation sequence in Excel for folios 1 to 138; allocation was concealed in sealed envelopes identified by folio number and opened immediately before the block. Each participant received a single block and was followed until 12 hours after surgery. Sedation and multimodal analgesia were standardized across groups.

Eligibility

Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No

Inclusion criteria

* Adults of any sex aged 18 to 59 years. * Scheduled for upper limb orthopedic or trauma surgery under brachial plexus block at Hospital General de Zona No. 3, IMSS, Aguascalientes. * American Society of Anesthesiologists (ASA) physical status I to III. * Signed informed consent.

Exclusion criteria

* Allergy to ropivacaine, lidocaine or epinephrine. * Emergency surgery. * Uncooperative patients. * Previous brachial plexus injury. * Upper limb neuropathy. * Inability to read or visual impairment preventing use of the pain scale.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pain Intensity at 6 Hours6 hours after the end of surgeryPain intensity measured with the 11-point Numeric Rating Scale (NRS), from 0 (no pain) to 10 (worst imaginable pain), compared among the three groups.

Secondary

MeasureTime frameDescription
Postoperative Pain Intensity at 0 and 12 HoursImmediately after the end of surgery (0 hours) and 12 hours after the end of surgeryPain intensity measured with the 11-point Numeric Rating Scale (NRS), from 0 (no pain) to 10 (worst imaginable pain).
Number of Participants Requiring Rescue Analgesia (Duration of Analgesia)At 0, 6 and 12 hours after the end of surgeryNumber of participants who received rescue analgesia at each assessment; participants without rescue at 6 hours were considered to have an analgesia duration of at least 6 hours.
Rescue Analgesic Consumption by Drug TypeUp to 12 hours after the end of surgeryNumber of participants receiving each rescue analgesic (acetaminophen, ketorolac, diclofenac, lysine clonixinate or opioids) and dose administered.
Number of Participants Receiving Postoperative OpioidsUp to 12 hours after the end of surgeryNumber of participants who received at least one opioid
Upper Limb Motor Block (Modified Bromage Scale)At 0, 6 and 12 hours after the end of surgeryMotor block of the blocked upper limb graded with the modified Bromage scale: 0 = full movement, 1 = decreased strength, 2 = partial movement, 3 = complete motor block.
Number of Participants With Block-Related Adverse EventsUp to 12 hours after the end of surgeryNausea, vomiting, paresthesia, puncture-site hematoma, Horner syndrome, dyspnea or phrenic nerve block, and local anesthetic systemic toxicity.

Countries

Mexico

Contacts

PRINCIPAL_INVESTIGATORCristina González Ramírez, MD, PhD

Instituto Mexicano del Seguro Social

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 31, 2026