A Novel Concept for Continuous Peripheral Nerve Block - Sciatic Nerve

Pain Clinical Trial

Official title:

A Novel Concept for Continuous Peripheral Nerve Block - Popliteal Region

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02456597
• Other study ID #: H-15000927
• Status: Completed
• Phase: N/A
• First received: April 1, 2015
• Last updated: October 13, 2015
• Start date: April 2015
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: Hillerod Hospital, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.-

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• lidocainhydrochlorid
Lidocaine injected through the novel Catheter
• Isotonic Saline
Isotonic saline injected through the novel Catheter

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kai Henrik Wiborg Lange

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle force (dynamometer) change from baseline	Decreased muscle force measured with a dynamometer after intervention	an average of three months	No
Secondary	Surface EMG (sEMG) change from baseline	Decreased EMG response (mV) after intervention	an average of three months	No
Secondary	Displacement of catheter (mm) change from initial placement	Displacement of catheter in millimeters assessed by ultrasound	an average of three months	No
Secondary	Cutaneous Sensory Mapping (Decreased sensibility in the region innervated by Tibial and Popliteal nerves) change from baseline	Decreased sensibility in the region innervated by Tibial and Popliteal nerves	an average of three months	No