Prospective RCT Lidocaine & Levobupivacaine on Block Dynamics After Subparaneural Popliteal Sciatic Nerve Block

A Prospective Randomized Comparison of the Effects of Lidocaine and Levobupivacaine on Block Dynamics After a Subparaneural Popliteal Sciatic Nerve Block

Sciatic nerve block at the popliteal fossa is indicated for foot or ankle surgery, and the introduction of ultrasound guidance (USG) has improved the ease and accuracy of the performance of this block. Recent studies proved that subparaneural injection is associated with faster block onset, higher block success rate, and prolonged block duration suggesting subparaneural compartment of the sciatic nerve is a desirable site for local anaesthetic injection. Data from an ongoing trial in the investigator's institution comparing the block dynamics of subparaneural injection of 30ml 0.5% levobupivacaine (Chirocaine) above and below the bifurcation of the sciatic nerve at popliteal fossa has also shown that the time to 'readiness for surgery' was faster when the injection was performed below the bifurcation of the sciatic nerve. Lidocaine (Xylocaine) has a better pharmacokinetic and pharmacodynamics profile than levobupivacaine and is also widely used as local anaesthetic agent in clinical practice. Since there is no data comparing the block dynamics of lidocaine and levobupivacaine, this study aims to study and compare the block dynamics of lidocaine and levobupivacaine when given as a subparaneural injection below the bifurcation of the sciatic nerve at the popliteal fossa. In this study, the investigator hypothesizes that the use of lidocaine as the sole agent for this block will fasten the time to 'readiness for surgery' as compared to levobupivacaine when given as a subparaneural injection below the bifurcation of the sciatic nerve at the popliteal fossa.

Study Overview

• Status: Recruiting
• Conditions: Musculoskeletal Diseases or Conditions
• Intervention / Treatment: Drug: 0.5% Levobupivacaine; Drug: 2% Xylocaine with adrenaline 1:200,000

Detailed Description

This study will involve performing ultrasound guided subparaneural popliteal sciatic nerve block for 40 patients by using either Lidocaine or Levobupivacaine. Both are commonly used local anaesthetics for regional anaesthesia in daily clinical practice. Patients will be enrolled from the elective orthopaedic surgical list at Prince of Wales Hospital after informed consent.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Cheuk Man Cheung, RN, BN, MSc; Phone Number: +85235052735; Email: cheukmancheung@cuhk.edu.hk

Study Locations

• Hong Kong
  • New Territories
    • Shatin, New Territories, Hong Kong
      • Recruiting
      • Prince of Wales Hospital
      • Contact: Manoj Karmakar; Phone Number: 97666237; Email: karmakar@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical status I-III
• adult and scheduled to undergo elective forefoot surgery under regional anaesthesia

Exclusion Criteria:

• patient refusal
• ASA physical status > III
• pregnancy
• neuromuscular disorder
• prior surgery in the popliteal fossa
• coagulopathy
• allergy to local anaesthetic drugs
• skin infection at the site of needle insertion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Levobupivacaine; 0.5% levobupivacaine (0.5% Chirocaine) 30ml (150mg) will be injected once for regional anaesthesia before surgery	Drug: 0.5% Levobupivacaine; The plane where the sciatic nerve bifurcates will at first be identified by utlrasound. 22-gauge insulated nerve block needle will be inserted in the short axis (out-of-plane) of the ultrasound transducer, and advanced toward the cleavage between the common peroneal nerve and the tibial nerve, which is the easiest location for needle access into subparaneural compartment.Once the needle tip enters the subparaneural compartment 2-3 ml of normal saline will be injected (hydro-distension) to create a halo around both the common peroneal nerve and tibial nerve distally and the sciatic nerve proximally. The needle is then redirected to place its tip into the paraneural sheath of the common peroneal and tibial nerve through the same skin puncture and 15ml of study drug will be injected at each site (total 30ml).; Other Names: Chirocaine
Active Comparator: Xylocaine + adrenaline; 2% Xylocaine with adrenaline 1:200,000 30ml (450mg) will be injected once for regional anaesthesia before surgery	Drug: 2% Xylocaine with adrenaline 1:200,000; The plane where the sciatic nerve bifurcates will at first be identified by utlrasound. 22-gauge insulated nerve block needle will be inserted in the short axis (out-of-plane) of the ultrasound transducer, and advanced toward the cleavage between the common peroneal nerve and the tibial nerve, which is the easiest location for needle access into subparaneural compartment.Once the needle tip enters the subparaneural compartment 2-3 ml of normal saline will be injected (hydro-distension) to create a halo around both the common peroneal nerve and tibial nerve distally and the sciatic nerve proximally. The needle is then redirected to place its tip into the paraneural sheath of the common peroneal and tibial nerve through the same skin puncture and 15ml of study drug will be injected at each site (total 30ml).; Other Names: Lignocaine and Adrenaline; Lidocaine and Adrenaline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete sensory blockade	Proportion of patients achieving complete sensory blockade (sensory score=0) at 30 minutes; Sensory score: VRS 0-100; 0=no sensation, 100=normal sensation	assessed within the first 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete motor blockade	Proportion of patients achieving complete motor blockade (motor score=0); Motor score: VRS 0-2; 2=normal, 1=paresis, 0=paralysis	assessed within the first 50 minutes after nerve block at regular intervals (5min, 10min, 15min, 20min, 25min, 30min, 40min, 50min)
Time to readiness for surgery	Sensory score =<30 and motor score=<1	assessed within the first 50 minutes after nerve block at regular intervals (5min, 10min, 15min, 20min, 25min, 30min, 40min, 50min)
Time to complete sensory and motor block	Sensory score =0 and motor score=0	assessed within the first 50 minutes after nerve block at regular intervals (5min, 10min, 15min, 20min, 25min, 30min, 40min, 50min)
Paresthesia	Any incidence of paresthesia during the nerve block	Intraoperative (during the period of undergoing the nerve block)
complications	Any complications during and right after the nerve block directly related to local anaesthetic toxicity	after the nerve block till the end of surgery
Discomfort score	the degree of discomfort during the nerve block (NRS : 0-100; 0=no discomfort, 100 very uncomfortable)	assess once 1 day before surgery

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Manoj K Karmakar, MD, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: RCT; sciatic nerve block; Lidocaine (Xylocaine) vs levobupivacaine
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Lidocaine; Levobupivacaine; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: RCT lido vs Levo Version 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No