Clinical trial NCT04397484: Prospective RCT Lidocaine & Levobupivacaine on Block Dynamics After Subparaneural Popliteal Sciatic Nerve Block
Official title: A Prospective Randomized Comparison of the Effects of Lidocaine and Levobupivacaine on Block Dynamics After a Subparaneural Popliteal Sciatic Nerve Block
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Musculoskeletal Diseases or Conditions
Keywords: RCT
Lidocaine (Xylocaine) vs levobupivacaine
sciatic nerve block
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Complete sensory blockade
timeFrame: assessed within the first 30 minutes
Secondary outcomes:
measure: Complete motor blockade
timeFrame: assessed within the first 50 minutes after nerve block at regular intervals (5min, 10min, 15min, 20min, 25min, 30min, 40min, 50min)
measure: Time to readiness for surgery
timeFrame: assessed within the first 50 minutes after nerve block at regular intervals (5min, 10min, 15min, 20min, 25min, 30min, 40min, 50min)
measure: Time to complete sensory and motor block
timeFrame: assessed within the first 50 minutes after nerve block at regular intervals (5min, 10min, 15min, 20min, 25min, 30min, 40min, 50min)
measure: Paresthesia
timeFrame: Intraoperative (during the period of undergoing the nerve block)
measure: complications
timeFrame: after the nerve block till the end of surgery
measure: Discomfort score
timeFrame: assess once 1 day before surgery
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
state: New Territories
Study officials:
affiliation: Chinese University of Hong Kong
name: Manoj K Karmakar, MD
role: PRINCIPAL_INVESTIGATOR
References: