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Not yet recruiting NCT06671028

Mixed Local for Sciatic Block

No phase Interventional Regional Anesthesia Local Anesthetic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ropivacaine and Lidocaine, Ropivacaine 0,5%.
Who it may be relevant to
Registry conditions: Regional Anesthesia, Local Anesthetic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Ropivacaine Versus Ropivacaine With Lidocaine Mixture in Poplitial-Sciatic Nerve Block for Below Knee Surgeries- A Randomized, Single Center Study

Overview

Choice of local anesthetics is the major determinant of the characteristics of a peripheral nerve block. Short acting local anesthetics while provides faster onset suffer from shorter duration. On the other hand, long acting local anesthetics while provides long duration suffered from long onset time. The ideal local anesthetics should provide faster nerve block onset while providing reasonable duration to provide sustained postoperative analgesia. Mixing short and long acting local anesthetics for nerve blocks may appear to be the solution however previous published studies have demonstrated similar onset time to long acting local anesthetics and with reduced duration. Recently, the London Health Sciences Centre established an ambulatory surgical centre. Fast onset peripheral nerve block is desirable. Previous studies have not looked at popliteal sciatic block and anecdotally we feel addition of short acting local anesthetics appear to speed up onset. We are therefore interested in conducting a randomize trial to determine whether mixing short and long acting local anesthetics can speed up onset of surgical quality block.

Interventions

  • Drug Ropivacaine and Lidocaine
    Popliteal sciatic block using Ropivacaine 100 mg and Lidocaine 100 mg in 20 mL
  • Drug Ropivacaine 0,5%
    Popliteal sciatic block using ropivacaine 0.5% 20 mL

Primary outcome measures

  • Time to complete sensory block [Time frame: Tested every 2 min up to 60 min]
Secondary outcome measures (3)
  • Duration of analgesia [Time frame: up to 48 hours after discharge]
  • Pain score at 6 hour post-block [Time frame: 6 hours after nerve block]
  • Patient satisfaction [Time frame: at 48 hour]

Eligibility criteria

Inclusion criteria

  • Adult patients (≥18 years old)
  • Scheduled for elective below-knee surgeries such as ankle arthroscopy, lower limb fracture fixation, toe surgeries, etc
  • Capable of providing informed consent

Exclusion criteria

  • History of allergic reaction to local anesthetics
  • Pre-existing neurological disorders affecting lower limbs
  • Significant renal or hepatic impairment
  • Pregnancy or breastfeeding
  • Less than 60kg
  • Inability to provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Bugamelli S, Zangheri E, Montebugnoli M, Borghi B, Ricci A, De Simone N, Bonfatti M, Elmar K, Luppi M, Pignotti E. One-day surgery for acquired forefoot deformity: sciatic nerve blockade with mepivacaine vs mepivacaine+ropivacaine: a prospective, randomized study. Minerva Anestesiol. 2007 Jan-Feb;73(1-2):57-64. PMID 17356507
  • Cuvillon P, Nouvellon E, Ripart J, Boyer JC, Dehour L, Mahamat A, L'hermite J, Boisson C, Vialles N, Lefrant JY, de La Coussaye JE. A comparison of the pharmacodynamics and pharmacokinetics of bupivacaine, ropivacaine (with epinephrine) and their equal volume mixtures with lidocaine used for femoral and sciatic nerve blocks: a double-blind randomized study. Anesth Analg. 2009 Feb;108(2):641-9. doi PMID 19151302
  • Valery P, Aliaksei M. A comparison of the onset time of complete blockade of the sciatic nerve in the application of ropivacaine and its equal volumes mixture with lidocaine: a double-blind randomized study. Korean J Anesthesiol. 2013 Jul;65(1):42-7. doi: 10.4097/kjae.2013.65.1.42. Epub 2013 Jul 19. PMID 23904938
  • Chen L, Wang Q, Shi K, Liu F, Liu L, Ni J, Fang X, Xu X. The effects of lidocaine used in sciatic nerve on the pharmacodynamics and pharmacokinetics of ropivacaine in sciatic nerve combined with lumbar plexus blockade: a double-blind, randomized study. Basic Clin Pharmacol Toxicol. 2013 Mar;112(3):203-8. doi: 10.1111/bcpt.12008. Epub 2012 Dec 6. PMID 22985391

Identifiers

NCT: NCT06671028 · 125572

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗