Mixed Local for Sciatic Block

NCT06671028 | Not Yet Recruiting

• 1 other identifier: 125572
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Regional Anesthesia; Local Anesthetic

Outcome Measures

Primary Outcomes (1)

• Time to complete sensory block

  The primary outcome is onset time for achievement of complete sensory block of the sciatic nerve determined via pinch test.

  Tested every 2 min up to 60 min

Secondary Outcomes (3)

• Duration of analgesia

  up to 48 hours after discharge

• Pain score at 6 hour post-block

  6 hours after nerve block

• Patient satisfaction

  at 48 hour

Study Arms (2)

Ropivacaine

ACTIVE COMPARATOR

Popliteal block using Ropivacaine 100 mg in 20 mL

Drug: Ropivacaine 0,5%

Ropivacaine anmd Lidocaine

EXPERIMENTAL

Popliteal sciatic block using Ropivacaine 100 mg and Lidocaine 100 mg in 20 mL

Drug: Ropivacaine and Lidocaine

Interventions

Ropivacaine and Lidocaine DRUG

Popliteal sciatic block using Ropivacaine 100 mg and Lidocaine 100 mg in 20 mL

Ropivacaine anmd Lidocaine

Ropivacaine 0,5% DRUG

Popliteal sciatic block using ropivacaine 0.5% 20 mL

Ropivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Related Publications (4)

• 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 BACKGROUND

• 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: 10.1213/ane.0b013e31819237f8.

  PMID: 19151302 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

Ropivacaine; Lidocaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides

Central Study Contacts

Cheng Lin

CONTACT

5196858500; cheng.lin@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 4, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: November 4, 2024

Record last verified: 2024-10