A Novel Concept for Continuous Peripheral Nerve Block - Sciatic Nerve

NCT02456597 | Completed DMC

• 1 other identifier: H-15000927
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Keywords

Peripheral Nerve Blocks

Outcome Measures

Primary Outcomes (1)

• Muscle force (dynamometer) change from baseline

  Decreased muscle force measured with a dynamometer after intervention

  an average of three months

Secondary Outcomes (3)

• Surface EMG (sEMG) change from baseline

  an average of three months

• Displacement of catheter (mm) change from initial placement

  an average of three months

• Cutaneous Sensory Mapping (Decreased sensibility in the region innervated by Tibial and Popliteal nerves) change from baseline

  an average of three months

Study Arms (2)

lidocainhydrochlorid

ACTIVE COMPARATOR

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

Drug: lidocainhydrochlorid

Isotonic saline

PLACEBO COMPARATOR

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

Drug: Isotonic Saline

Interventions

lidocainhydrochlorid DRUG

Lidocaine injected through the novel Catheter

Also known as: Lidocaine, Xylocaine

lidocainhydrochlorid

Isotonic Saline DRUG

Isotonic saline injected through the novel Catheter

Also known as: Saline

Isotonic saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.-

Sponsors & Collaborators

• Kai Henrik Wiborg Lange: lead

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Christian Rothe

  Nordsjaellands Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head Of Research

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: May 28, 2015
• Study Start: April 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 15, 2015

Record last verified: 2015-10