The Effect of Local Anaesthetic Volume on Nerve Block Duration and Nerve Block Duration Variability

NCT02829697 | Completed Phase 4 DMC

• 1 other identifier: H-16000184
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The aim is to investigate the effect of perineural administration of a series of different volumes of local anaesthesia (ropivacaine 0.2%) on nerve block duration and the variability of the duration in the common peroneal nerve and the sciatic nerve in healthy volunteers. The hypothesis is that nerve block duration is correlated to local anaesthetic volume, but only to a certain degree. After a sufficient volume a 'saturation level' will be reached, and nerve block duration will not increase further.

Conditions

Postoperative Pain

Keywords

Regional anaesthesia

Outcome Measures

Primary Outcomes (1)

• Duration of sensory nerve block

  Application of a round, cooled glass container in the sensory distribution area of the tested nerve: The lateral part of the lower leg for the common peroneal nerve and beneath the foot for the tibial nerve. Testing will start after onset of sensory nerve block and continue until normal sensation has returned. When testing the sciatic nerve, we will continue testing until normal sensation has returned in both components of the nerve, i.e. the tibial and common peroneal nerve.

  1-24 hours

Secondary Outcomes (5)

• Length of nerve exposed to local anaesthesia

  10 minutes

• Onset of sensory nerve block

  10-180 minutes

• Onset of motor nerve block

  10-180 minutes

• Degree of sensory nerve block

  1-24 hours

• Degree of motor nerve block

  1-24 hours

Study Arms (10)

Peroneal nerve: Ropivacaine 0.2%, 2.5 mL

ACTIVE COMPARATOR

Perineural injection of ropivacaine 0.2 %, 2,5 mL

Drug: Ropivacaine

Peroneal nerve: Ropivacaine 0.2%, 5 mL

ACTIVE COMPARATOR

Perineural injection of ropivacaine 0.2 %, 5 mL

Drug: Ropivacaine

Peroneal nerve: Ropivacaine 0.2%, 10 mL

ACTIVE COMPARATOR

Perineural injection of ropivacaine 0.2 %, 10 mL

Drug: Ropivacaine

Peroneal nerve: Ropivacaine 0.2%, 15 mL

ACTIVE COMPARATOR

Perineural injection of ropivacaine 0.2 %, 15 mL

Drug: Ropivacaine

Peroneal nerve: Ropivacaine 0.2%, 20 mL

ACTIVE COMPARATOR

Perineural injection of ropivacaine 0.2 %, 20 mL

Drug: Ropivacaine

Sciatic nerve: Ropivacaine 0.2%, 5 mL

ACTIVE COMPARATOR

Perineural injection of ropivacaine 0.2 %, 5 mL

Drug: Ropivacaine

Sciatic nerve: Ropivacaine 0.2%, 10 mL

ACTIVE COMPARATOR

Perineural injection of ropivacaine 0.2 %, 10 mL

Drug: Ropivacaine

Sciatic nerve: Ropivacaine 0.2%, 15 mL

ACTIVE COMPARATOR

Perineural injection of ropivacaine 0.2 %, 15 mL

Drug: Ropivacaine

Sciatic nerve: Ropivacaine 0.2%, 20 mL

ACTIVE COMPARATOR

Perineural injection of ropivacaine 0.2 %, 20 mL

Drug: Ropivacaine

Sciatic nerve: Ropivacaine 0.2%, 30 mL

ACTIVE COMPARATOR

Perineural injection of ropivacaine 0.2 %, 30 mL

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

Perineural injection.

Peroneal nerve: Ropivacaine 0.2%, 10 mL; Peroneal nerve: Ropivacaine 0.2%, 15 mL; Peroneal nerve: Ropivacaine 0.2%, 2.5 mL; Peroneal nerve: Ropivacaine 0.2%, 20 mL; Peroneal nerve: Ropivacaine 0.2%, 5 mL; Sciatic nerve: Ropivacaine 0.2%, 10 mL; Sciatic nerve: Ropivacaine 0.2%, 15 mL; Sciatic nerve: Ropivacaine 0.2%, 20 mL; Sciatic nerve: Ropivacaine 0.2%, 30 mL; Sciatic nerve: Ropivacaine 0.2%, 5 mL

Eligibility Criteria

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

You may qualify if:

• Male or female 18-64 years
• American Society of Anesthesiologists Classification ≤ II

You may not qualify if:

• Body Mass Index ≤ 18 or ≥ 30
• Former surgery to the lower extremities
• Peripheral nerve disease
• Allergy to ropivacaine
• Pregnancy or breastfeeding
• Enrolment in other investigational drug studies or recent clinical trials that may interfere with this study
• Habitual use of any kind of analgesic treatment
• Anatomic abnormalities preventing successful US-guided peripheral nerve catheter insertion

Sponsors & Collaborators

• Nordsjaellands Hospital: lead
• Innovation Fund Denmark: collaborator

Study Sites (1)

Claus Behrend Christiansen

Hillerød, DK-3400, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Kai Henrik Wiborg Lange, MD DMSC

  Nordsjællands Hospital Hillerød

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: July 12, 2016
• Study Start: July 1, 2016
• Primary Completion: March 20, 2017
• Study Completion: March 20, 2017
• Last Updated: March 22, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)