Actively Recruiting

Phase 4
Age: 18Years - 75Years
All Genders
ID04397484

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

Led by Chinese University of Hong Kong · Updated on 2025-04-13

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the block dynamics of lidocaine and levobupivacaine when given as a subparaneural injection below the bifurcation of the sciatic nerve at the popliteal fossa. This study focuses on patients undergoing elective forefoot surgery and aims to compare the time to readiness for surgery and the success of the nerve block using these two local anesthetics. The trial is a phase 4, randomized, quadruple-blind study sponsored by the Chinese University of Hong Kong. The study involves performing an ultrasound-guided subparaneural popliteal sciatic nerve block in 40 patients. Participants will receive a single injection of either 0.5% levobupivacaine (30ml) or 2% lidocaine with adrenaline 1:200,000 (30ml) before surgery. The injection technique involves hydro-distension with saline to create a halo around the nerves, followed by local anesthetic injection at two sites through the same skin puncture. During the study, researchers will monitor the onset and completeness of sensory and motor blockades at regular intervals up to 50 minutes after the nerve block. They will assess the primary outcome of complete sensory blockade within 30 minutes, and secondary outcomes including motor blockade, time to readiness for surgery, paresthesia during the block, complications during surgery, and discomfort scores one day before surgery. Patient safety and block effectiveness will be closely observed throughout the surgical procedure.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • American Society of Anesthesiologists (ASA) physical status I-III
  • Adults aged 18 to 75 years
  • Scheduled to undergo elective forefoot surgery under regional anesthesia
Not Eligible

You will not qualify if you...

  • Patient refusal
  • ASA physical status greater than III
  • Pregnancy
  • Neuromuscular disorder
  • Prior surgery in the popliteal fossa
  • Coagulopathy
  • Allergy to local anesthetic drugs
  • Skin infection at the site of needle insertion

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single administration on the day of surgery

Participants receive an ultrasound guided subparaneural popliteal sciatic nerve block injection of either Lidocaine or Levobupivacaine prior to elective forefoot surgery.

1 treatment visit (in-person)

Follow-up

Duration - Up to 1 day post treatment

Participants are monitored for sensory and motor blockade effects and any complications from the nerve block during and immediately after surgery.

Assessments conducted at multiple intervals within 50 minutes after nerve block and 1 visit 1 day before surgery for discomfort score

Trial Site Locations

Total: 1 location

1

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

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Research Team

A

Ayla Wong, RN, BN

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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