A Novel Concept for Continuous Peripheral Nerve Block - Sciatic Nerve

A Novel Concept for Continuous Peripheral Nerve Block - Popliteal Region

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: lidocainhydrochlorid; Drug: Isotonic Saline

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle force (dynamometer) change from baseline	Decreased muscle force measured with a dynamometer after intervention	an average of three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surface EMG (sEMG) change from baseline	Decreased EMG response (mV) after intervention	an average of three months
Displacement of catheter (mm) change from initial placement	Displacement of catheter in millimeters assessed by ultrasound	an average of three months
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

Collaborators and Investigators

• Sponsor: Kai Henrik Wiborg Lange
• Investigators: Principal Investigator: Christian Rothe, Nordsjællands Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: April 1, 2015
• First Submitted That Met QC Criteria: May 27, 2015
• First Posted (Estimate): May 28, 2015

Study Record Updates

• Last Update Posted (Estimate): October 15, 2015
• Last Update Submitted That Met QC Criteria: October 13, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Peripheral Nerve Blocks
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: H-15000927