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OpenTrials
Completed

NCT Number: NCT02456597

A Novel Concept for Continuous Peripheral Nerve Block - Sciatic Nerve

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female ≥18 years of age at Visit X.
  • ASA classification ≤ II
  • Written informed consent obtained from volunteer and ability for volunteer to comply with the requirements of the study.

Exclusion criteria

  • BMI ≥ 30
  • Previous or ongoing surgery, pain or other disability of investigated region.
  • Prescriptive drugs other than anti-contraceptive.
  • Sensory or neurologic deficits in the investigated region
  • Allergy to LA
  • Pregnancy, breastfeeding, or unwilling to practice birth control during participation in the study.-

Treatment and study plan

lidocainhydrochlorid

Drug

Lidocaine injected through the novel Catheter

Other names: Lidocaine, Xylocaine

Isotonic saline

Drug

Isotonic saline injected through the novel Catheter

Other names: Saline

Primary outcomes

  1. Muscle force (dynamometer) change from baseline

    Time frame: an average of three months

    Decreased muscle force measured with a dynamometer after intervention

Secondary outcomes

  1. Surface EMG (sEMG) change from baseline

    Time frame: an average of three months

    Decreased EMG response (mV) after intervention

  2. Displacement of catheter (mm) change from initial placement

    Time frame: 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

    Time frame: an average of three months

    Decreased sensibility in the region innervated by Tibial and Popliteal nerves

Sponsors and collaborators

Lead sponsor

Kai Henrik Wiborg Lange

Other

Registry information

Official study title

A Novel Concept for Continuous Peripheral Nerve Block - Popliteal Region

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 28, 2015
Registry last updated
Oct 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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