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A Novel Concept for Continuous Peripheral Nerve Block - Sciatic Nerve

Sponsor
Kai Henrik Wiborg Lange (Other)
Overall Status
Completed
CT.gov ID
NCT02456597
Collaborator
(none)
16
Enrollment
2
Arms
2
Duration (Months)

Study Details

Study Description

Brief Summary

To investigate the function of a novel catheter for continuous peripheral nerve blocks in the popliteal nerve: Two key issues are investigated 1) Successful primary placement and function of the catheter for continuous peripheral nerve blocks confirmed by a decrease in motor function following injection of local analgesics through the catheter; 2) The rate of displacement after standardized movement of the limb where the catheter for continuous peripheral nerve blocks is inserted.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Although peripheral nerve blocks are known to provide superior postoperative analgesia. Continuous peripheral nerve block (CPNB) are not used to the extent they deserve. This is predominantly due to variable success rates. Furthermore, the existing techniques for placing catheters for CPNBs are technically complicated and time consuming.4,5 Major problems include difficult insertion of the catheter tip past the needle, difficult visualization of catheter advancement, secondary displacement of the local anesthetic (LA) injection orifice(s) and limited possibility of repositioning the catheter once it has been left in situ. We have developed a new catheter for CPNBs to address and overcome these limitations.

Hence, the new catheter should primarily provide precise initial placement of the catheter, less risk of secondary displacement and a possibility to readjust the new catheter at any time point after initial placement. Furthermore, in-plane ultrasound (US) visualization during the entire procedure and during readjustment should be possible. The new catheter should also provide a simple and rapid technique with few components. Initial proof of concept studies in cadavers are promising with success rates close to 100 % both for initial placement and readjustment

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title:
A Novel Concept for Continuous Peripheral Nerve Block - Popliteal Region
Study Start Date :
Apr 1, 2015
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: lidocainhydrochlorid

Lidocaine 20mg/ml, 15 ml injected perineural at the sciatic nerve

Drug: lidocainhydrochlorid
Lidocaine injected through the novel Catheter
Other Names:
  • Lidocaine, Xylocaine

    		•
    Placebo Comparator: Isotonic saline

    0.9% Saline Solution, 15ml injected perineural at the contralateral sciatic nerve

    Drug: Isotonic Saline
    Isotonic saline injected through the novel Catheter
    Other Names:
  • Saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Muscle force (dynamometer) change from baseline [an average of three months]

      Decreased muscle force measured with a dynamometer after intervention

    Secondary Outcome Measures

    1. Surface EMG (sEMG) change from baseline [an average of three months]

      Decreased EMG response (mV) after intervention

    2. Displacement of catheter (mm) change from initial placement [an average of three months]

      Displacement of catheter in millimeters assessed by ultrasound

    3. Cutaneous Sensory Mapping (Decreased sensibility in the region innervated by Tibial and Popliteal nerves) change from baseline [an average of three months]

      Decreased sensibility in the region innervated by Tibial and Popliteal nerves

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Male or female ≥18 years of age at Visit X.

    2. ASA classification ≤ II

    3. Written informed consent obtained from volunteer and ability for volunteer to comply with the requirements of the study.

    Exclusion Criteria:

    1. BMI ≥ 30

    2. Previous or ongoing surgery, pain or other disability of investigated region.

    3. Prescriptive drugs other than anti-contraceptive.

    4. Sensory or neurologic deficits in the investigated region

    5. Allergy to LA

    6. Pregnancy, breastfeeding, or unwilling to practice birth control during participation in the study.-

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Kai Henrik Wiborg Lange

    Investigators

    • Principal Investigator: Christian Rothe, Nordsjællands Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kai Henrik Wiborg Lange, Head Of Research, Hillerod Hospital, Denmark
    ClinicalTrials.gov Identifier:
    NCT02456597
    Other Study ID Numbers:
    • H-15000927
    First Posted:
    May 28, 2015
    Last Update Posted:
    Oct 15, 2015
    Last Verified:
    Oct 1, 2015
    Keywords provided by Kai Henrik Wiborg Lange, Head Of Research, Hillerod Hospital, Denmark
    Peripheral Nerve Blocks
    Additional relevant MeSH terms:
    Lidocaine

    Study Results

    No Results Posted as of Oct 15, 2015