Local Anesthetic Concentration and Nerve Block Duration

Peripheral Nerve Block Clinical Trial

Official title:

Local Anesthetic Concentration and Nerve Block Duration: A Randomized, Blinded Study in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03326609
• Other study ID #: H-17022555
• Status: Completed
• Phase: Phase 4
• First received: September 29, 2017
• Last updated: January 5, 2018
• Start date: October 4, 2017
• Est. completion date: January 5, 2018

Study information

• Verified date: January 2018
• Source: Nordsjaellands Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Local anesthetic (LA) concentration and nerve block duration is sparsely described in a heterogenic study mass.

Aim: To investigate the effect of LA concentration on peripheral nerve block duration in healthy volunteers.

Methods: Randomization of 60 healthy volunteers who will receive 1 of 5 different volumes of LA (ropivacaine) using a constant dose.

Primary endpoint: Sensory nerve block defined by insensitivity towards cold.

Description:

Background:

Important factors for a safe and successful nerve block include volume, dose and concentration of local anesthetic (LA). Knowing the duration of peripheral nerve blocks is important to prevent pain breakthrough. With the advancements in ultrasound (US)-guided nerve block techniques it has been possible to substantially reduce the amount of LA required to perform a successful nerve block. This has reduced the risk of systemic toxicity. However, lowering LA volume may reduce nerve block duration, but the extent of this is sparsely described in a heterogenic study mass.

Diluted and large volumes of LA seem to correlate with nerve block duration. Furthermore, increasing LA concentration seems to increase the level of motor block, but not the block duration. A long-lasting nerve block without dense motor block is preferable for optimized pain control and better opportunities to rehabilitate/ambulate.

Aim:

To investigate the effect of LA concentration on common peroneal nerve block duration in healthy volunteers.

Methods:

Randomization of 60 healthy volunteers who will receive 1 of 5 different volumes of LA (ropivacaine) using a constant dose (10mg).

Primary outcome: Duration of sensory nerve block defined by insensitivity towards cold.

Secondary outcome: Duration of motor nerve block defined by either paresis or paralysis.

Explorative outcomes: Degrees of sensory and motor nerve block; Onset times of sensory and motor nerve block; Length of neural exposure to LA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 5, 2018
• Est. primary completion date: December 8, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion criteria

1. Male or female from and above 18 years of age

2. ASA classification = II

Exclusion criteria

1. BMI below 18 kg/m2

2. Former surgery to the lower extremity in which intervention is planned and surgery which may have caused neural damage to the common peroneal nerve/affected the sensory distribution area of the common peroneal nerve

3. Peripheral nerve disease

4. Allergy to LA

5. Pregnancy or breastfeeding

6. Enrolment in other investigational drug studies or recent clinical trials that may interfere with this study

7. Habitual use of any kind of analgesic treatment

8. Anatomic abnormalities preventing successful US-guided peripheral nerve catheter insertion

Related Conditions & MeSH terms

• Peripheral Nerve Block

Intervention

Drug:
• Ropivacaine
Perineural injection using a peripheral nerve block catheter and a constant infusion rate (10mL/h)

Locations

Country	Name	City	State
Denmark	Nordsjællands Hospital	Hillerød	Danmark

Sponsors (2)

Lead Sponsor	Collaborator
Nordsjaellands Hospital	Innovation Fund Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of neural exposure to local anesthetic	Ultrasound-guided measurement of the perineural spread of local anesthetic. From the most distal to the most proximal point. Measured in millimetres.	10 minutes
Other	Onset of sensory nerve block	Insensitivity towards cold. Testing will start 10 minutes after end of LA infusion and continue every 5 minutes until onset is apparent.	10-180 minutes
Other	Onset of motor nerve block	Paresis or paralysis of ankle dorsiflexion. Testing will start 10 minutes after end of LA infusion and continue every 5 minutes until onset of sensory nerve block is apparent.	10-180 minutes
Other	Degree of sensory nerve block	Grading system using a 4-level scale and compared to the contralateral leg: 1) normal; 2) different; 3) warmth; 4) no sensation. Testing will start after onset of sensory nerve block and will be done in intervals of 60 minutes hereafter and continue until return of normal sensation.	1-24 hours
Other	Degree of motor nerve block	Grading system using a 3-level scale and compared to the contralateral leg: 1) normal; 2) paresis; 3) paralysis. Testing will start after onset of sensory nerve block and will be done in intervals of 60 minutes hereafter and continue until return of normal sensation.	1-24 hours
Primary	Duration of sensory nerve block	Insensitivity towards cold. Testing will start after onset of sensory nerve block and will be done in intervals of 60 minutes hereafter and continue until return of normal sensation.	1-24 hours
Secondary	Duration of motor nerve block	Paresis or paralysis of ankle dorsiflexion. Testing will start after onset of sensory nerve block and will be done in intervals of 60 minutes hereafter and continue until return of normal sensation.	1-24 hours