Popliteal SNB:Evaluation of Block Dynamics After Subparaneural Injection Below CPN & TN

NCT04506879 | Completed

• 1 other identifier: CREC.2020.314
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the effect of twin subparaneural injection into individual paraneural sheaths of Common Peroneal Nerve (CPN) and Tibial Nerve (TN) below their point of divergence from the sciatic nerve on the sensory motor blockade after Popliteal Sciatic Nerve Block (PSNB) at the popliteal fossa (back of the thigh) for patients requiring lower limb surgeries.

Conditions

Musculoskeletal Diseases or Conditions

Keywords

Popliteal Sciatic nerve block

Outcome Measures

Primary Outcomes (1)

• the percentage of patients with complete sensory and motor block at 30 min

  VRS=0 for both sensory and motor score at 30 min. The extent of the sensory blockade will be graded according to VRS (verbal rating scale) for sensory assessment (100 = normal sensation to 0 = no sensation) in the areas innervated by the sciatic nerve. Motor blockade of the deep peroneal nerve (dorsal flexion of the ankle) and tibial nerve (plantar flexion of the ankle) will be graded using a 3-point scale: 2 = normal, 1 = paresis, and 0 = paralysis.

  within 45 minutes after the block (at 5min, 10min, 15min, 20 min, 25min, 30min, 45 min)

Secondary Outcomes (4)

• The time taken to complete sensory and motor blockade at 30 min, time to 'readiness for surgery'

  within 45 minutes after the block (at 5min, 10min, 15min, 20 min, 25min, 30min, 45min)

• Success rate of the block

  within 45 minutes after the block (at 5min, 10min, 15min, 20min, 25min, 30min, 45min)

• Complication

  from immediately after the block till 24 hours afterwards

• Paraesthesia and degree of discomfort

  during the block

Study Arms (1)

Popliteal Sciatic Nerve block

OTHER

Patients will lie on their chest on the examination couch with both feet rested on the pillow to relax their lower extremity. Ultrasound scan of the nerves in popliteal fossa will be identified and then local anesthetic agents \[1.5% lidocaine with 1:200,000 adrenaline and 0.5ml of 8.4% sodium bicarbonate (total 30ml)\] will be injected close to the nerves (Common peroneal nerve and tibial nerve). The injections below the bifurcation near the two nerves are expected to produce quicker block than the injections above the bifurcation.

Procedure: Popliteal Sciatic nerve block

Interventions

Popliteal Sciatic nerve block PROCEDURE

Patients schedule for lower limb surgery under regional anesthesia will receive ultrasound guided subparaneural popliteal sciatic nerve block. After identification of the common peroneal nerve and tibial nerve, local anesthetic agents will be injected close to each nerve below the point of divergence at the popliteal fossa. The spread of the drug and the sensory and motor function of that limb will be assessed regularly till it is ready for surgery.

Popliteal Sciatic Nerve block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I-III scheduled to undergo elective foot and/or ankle surgery under regional anesthesia.

You may not qualify if:

• Patient refusal, ASA physical status \> Ⅲ, pregnancy, neuromuscular disorder, prior surgery in the popliteal fossa, coagulopathy, allergy to local anaesthetic drugs, and skin infection at the site of needle insertion.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

• Manoj K Karmakar, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 10, 2020
• Study Start: May 27, 2021
• Primary Completion: June 16, 2023
• Study Completion: July 16, 2023
• Last Updated: August 9, 2023

Record last verified: 2023-08

Locations

HK (1)