A Novel Concept for Continuous Peripheral Nerve Block - Sciatic Nerve

NCT ID: NCT02456597

Last Updated: 2015-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-06-30

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.

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

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: QUADRUPLE

Study Groups

lidocainhydrochlorid

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

Group Type: ACTIVE_COMPARATOR

lidocainhydrochlorid

Intervention Type: DRUG

Lidocaine injected through the novel Catheter

Isotonic saline

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

Group Type: PLACEBO_COMPARATOR

Isotonic Saline

Intervention Type: DRUG

Isotonic saline injected through the novel Catheter

Interventions

lidocainhydrochlorid

Lidocaine injected through the novel Catheter

Intervention Type: DRUG

Isotonic Saline

Isotonic saline injected through the novel Catheter

Intervention Type: DRUG

Other Intervention Names

Lidocaine, Xylocaine; Saline

Eligibility Criteria

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.-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kai Henrik Wiborg Lange

OTHER

Sponsor Role: lead

Responsible Party

Kai Henrik Wiborg Lange

Head Of Research

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Christian Rothe

Role: PRINCIPAL_INVESTIGATOR

Nordsjaellands Hospital

Other Identifiers

H-15000927

Identifier Type: -

Identifier Source: org_study_id