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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04397484
Other study ID # RCT lido vs Levo Version 2
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 20, 2023
Est. completion date September 30, 2024

Study information

Verified date August 2023
Source Chinese University of Hong Kong
Contact Cheuk Man Cheung, RN, BN, MSc
Phone +85235052735
Email cheukmancheung@cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date September 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).
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).

Locations

Country Name City State
Hong Kong Prince of Wales Hospital Shatin New Territories

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary Paresthesia Any incidence of paresthesia during the nerve block Intraoperative (during the period of undergoing the nerve block)
Secondary 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
Secondary 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
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