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

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ClinicalTrials.gov Identifier: NCT04397484
Recruitment Status : Not yet recruiting
First Posted : May 21, 2020
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
Prof Manoj K Karmakar, Chinese University of Hong Kong

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Musculoskeletal Diseases or Conditions Drug: 0.5% Levobupivacaine Drug: 2% Xylocaine with adrenaline 1:200,000 Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The randomization sequence will be generated using online randomization software. The randomization sequence will be assigned as Group 1 =0.5% Chirocaine (levobupivacaine) and Group 2 =1.5% Xylocaine with adrenaline 1:200,000, and the group allocation will be sealed within an opague envelop by a research assistant, who is not involved in this study. After recruitment, patients will be randomly allocated to receive ultrasound guided subparaneural popliteal sciatic nerve block below bifurcation using either 0.5% Chirocaine (levobupivacaine) (Group 1) or 1.5% Xylocaine with adrenaline 1: 200,000 (Group 2).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
  1. Patients will be blinded to the treatment arm in which he/she is allocated to.
  2. Anesthesiologist performing the block will receive identical syringes with equal volume of local anaesthetics, prepared by a nurse/ pharmacist who is not involved in the study.
  3. Anaesthesiologist performing the block will be blinded.
  4. Outcome assessor assessing the outcomes will be blinded.
Primary Purpose: Treatment
Official Title: A Prospective Randomized Comparison of the Effects of Lidocaine and Levobupivacaine on Block Dynamics After a Subparaneural Popliteal Sciatic Nerve Block
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : June 4, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine


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 Name: 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




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


Secondary Outcome Measures :
  1. Complete motor blockade [ Time Frame: assessed within the first 50 minutes after nerve block at regular intervals (5min, 10min, 15min, 20min, 25min, 30min, 40min, 50min) ]
    Proportion of patients achieving complete motor blockade (motor score=0); Motor score: VRS 0-2; 2=normal, 1=paresis, 0=paralysis

  2. Time to readiness for surgery [ Time Frame: assessed within the first 50 minutes after nerve block at regular intervals (5min, 10min, 15min, 20min, 25min, 30min, 40min, 50min) ]
    Sensory score =<30 and motor score=<1

  3. Time to complete sensory and motor block [ Time Frame: assessed within the first 50 minutes after nerve block at regular intervals (5min, 10min, 15min, 20min, 25min, 30min, 40min, 50min) ]
    Sensory score =0 and motor score=0

  4. Paresthesia [ Time Frame: Intraoperative (during the period of undergoing the nerve block) ]
    Any incidence of paresthesia during the nerve block

  5. complications [ Time Frame: after the nerve block till the end of surgery ]
    Any complications during and right after the nerve block directly related to local anaesthetic toxicity

  6. Discomfort score [ Time Frame: assess once 1 day before surgery ]
    the degree of discomfort during the nerve block (NRS : 0-100; 0=no discomfort, 100 very uncomfortable)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04397484


Contacts
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Contact: Winnie Samy, RN, BN, MSc +85235052735 wsamy@cuhk.edu.hk

Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Manoj K Karmakar, MD Chinese University of Hong Kong
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Responsible Party: Prof Manoj K Karmakar, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04397484    
Other Study ID Numbers: RCT lido vs Levo Version 2
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Prof Manoj K Karmakar, Chinese University of Hong Kong:
RCT
Lidocaine (Xylocaine) vs levobupivacaine
sciatic nerve block
Additional relevant MeSH terms:
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Musculoskeletal Diseases
Lidocaine
Epinephrine
Racepinephrine
Levobupivacaine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents