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

Phase 4

Recruiting

• Conditions: Musculoskeletal Diseases or Conditions
• Interventions: Drug: 0.5% Levobupivacaine

• Registration Number: NCT04397484
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-21
• Status Verified: 2023-08
• Study Start: 2023-09-20
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-25
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levobupivacaine	0.5% Levobupivacaine	0.5% levobupivacaine (0.5% Chirocaine) 30ml (150mg) will be injected once for regional anaesthesia before surgery

Primary Outcome Measures

Name	Time	Method
Complete sensory blockade	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

Name	Time	Method
Time to complete sensory and motor block	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
Complete motor blockade	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
Time to readiness for surgery	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
Paresthesia	Intraoperative (during the period of undergoing the nerve block)	Any incidence of paresthesia during the nerve block
complications	after the nerve block till the end of surgery	Any complications during and right after the nerve block directly related to local anaesthetic toxicity
Discomfort score	assess once 1 day before surgery	the degree of discomfort during the nerve block (NRS : 0-100; 0=no discomfort, 100 very uncomfortable)

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Shatin, New Territories, Hong Kong