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

Primary Purpose

Musculoskeletal Diseases or Conditions

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Popliteal Sciatic nerve block
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Diseases or Conditions focused on measuring Popliteal Sciatic nerve block

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Prince of Wales Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Popliteal Sciatic Nerve block

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The time taken to complete sensory and motor blockade at 30 min, time to 'readiness for surgery'
The time point where the sensory block was =< 30 VRS (VRS 0-100, 100=normal sensation and 0= no sensation) and a motor blockade of =< 1 (2=normal, 1=paresis, 0=paralysis),
Success rate of the block
complete abolition of sensation to cold and paralysis of the muscles in the ipsilateral calf and foot
Complication
any local anesthetic toxicity
Paraesthesia and degree of discomfort
Paresthesia (yes or no); degree if discomfort (numeric rating scale 0-100)

Full Information

First Posted
August 7, 2020
Last Updated
August 8, 2023
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04506879
Brief Title
Popliteal SNB:Evaluation of Block Dynamics After Subparaneural Injection Below CPN & TN
Official Title
Ultrasound Guided Popliteal Sciatic Nerve Block: Evaluation of Block Dynamics After a Twin Subparaneural Injection Below the Divergence of Common Peroneal and Tibial Nerve.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 27, 2021 (Actual)
Primary Completion Date
June 16, 2023 (Actual)
Study Completion Date
July 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Ultrasound (US) guided Popliteal Sciatic Nerve Block (PSNB) has been routinely used to provide surgical anaesthesia for ankle and foot surgeries, and the introduction of ultrasound (US) guidance has improved the ease and accuracy of performing PSNB. However, the challenge of achieving the optimal 'readiness for surgery' time after the US guided PSNB continues to confront anaesthesiologists. Cumulative evidence indicates that a subparaneural PSNB improves sensory motor block outcome when compared to subepimyseal PSNB where the local anaesthetic is deposited outside the paraneural sheath. While these are encouraging results, producing sensory motor blockade, i.e. surgical anaesthesia in the area innervated by the sciatic nerve within 30 minutes of local anaesthetic (LA) injection, after a subparaneural PSNB, remains a challenge with the success rate varying from 62-92%. Reasons for this shortcoming, despite LA being deposited in subparaneural space, close to the epineurium of the sciatic nerve, is probably multifactorial as the nerve size, surface area exposed to local anaesthetic, and internal architecture (the connective tissue component) of the sciatic nerve and its branches are all seems to influence block onset time and completeness. It was observed from our clinical practice that distal subparaneural injection (twin halo) into individual paraneural sheaths of common peroneal nerve (CPN) and tibial nerve (TN) below the point of divergence at the popliteal fossa demonstrated a faster sensory motor blockade after PSNB. Therefore, this study aims to assess the effect of twin subparaneural injection into individual paraneural sheaths of CPN and TN below their point of divergence from the sciatic nerve on the sensory motor blockade after PSNB at the popliteal fossa.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Diseases or Conditions
Keywords
Popliteal Sciatic nerve block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Popliteal Sciatic Nerve block
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Popliteal Sciatic nerve block
Intervention Description
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.
Primary Outcome Measure Information:
Title
the percentage of patients with complete sensory and motor block at 30 min
Description
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.
Time Frame
within 45 minutes after the block (at 5min, 10min, 15min, 20 min, 25min, 30min, 45 min)
Secondary Outcome Measure Information:
Title
The time taken to complete sensory and motor blockade at 30 min, time to 'readiness for surgery'
Description
The time point where the sensory block was =< 30 VRS (VRS 0-100, 100=normal sensation and 0= no sensation) and a motor blockade of =< 1 (2=normal, 1=paresis, 0=paralysis),
Time Frame
within 45 minutes after the block (at 5min, 10min, 15min, 20 min, 25min, 30min, 45min)
Title
Success rate of the block
Description
complete abolition of sensation to cold and paralysis of the muscles in the ipsilateral calf and foot
Time Frame
within 45 minutes after the block (at 5min, 10min, 15min, 20min, 25min, 30min, 45min)
Title
Complication
Description
any local anesthetic toxicity
Time Frame
from immediately after the block till 24 hours afterwards
Title
Paraesthesia and degree of discomfort
Description
Paresthesia (yes or no); degree if discomfort (numeric rating scale 0-100)
Time Frame
during the block

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I-III scheduled to undergo elective foot and/or ankle surgery under regional anesthesia. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manoj K Karmakar, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Shatin
State/Province
New Territories
Country
Hong Kong

12. IPD Sharing Statement

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

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