Pain, Postoperative Clinical Trial
Official title:
Effects of Local Anaesthetic Infusion Rates on Nerve Block Duration. A Randomised, Blinded, Healthy Volunteer Study
Verified date | June 2016 |
Source | Nordsjaellands Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial is a part of the project: 'A novel technique for reliable, precise and safe
postoperative pain management' (project no. 65-2014-3).
The purpose of the trial is to investigate the effects of changing peri-neural infusion
rates of ropivacaine 0.2% on the duration of nerve block.
Intervention:
Two intervention-days. Each day a peri-neural infusion of a fixed volume of ropivacaine 0.2%
is to be infused in one of five infusion rates, using a peri-neural catheter.
Intervention day 1: Focus on the common peroneal nerve. Intervention day 2: Focus on the
sciatic nerve.
Status | Terminated |
Enrollment | 60 |
Est. completion date | December 9, 2016 |
Est. primary completion date | November 23, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility |
Inclusion criteria 1. Male or female =18, = 64 years of age 2. ASA classification17 = II Exclusion criteria 1. BMI = 18 or = 30 kg/m2 2. Body weight = 37.5 kg 3. Former surgery to the lower extremities 4. Peripheral nerve disease, including polyneuropathy and diabetes 5. Allergy to local anaesthetics 6. Pregnancy or breastfeeding 7. Enrolment in other investigational drug studies or recent clinical trials that may interfere with this study 8. Habitual use of any kind of analgesic treatment 9. Anatomic abnormalities preventing successful US-guided Certa Catheter™ insertion. |
Country | Name | City | State |
---|---|---|---|
Denmark | Research Unit, Department of Anaesthesiology and Intensive Care, Nordsjaellands Hospital Hilleroed | Hilleroed | Capital Region of Denmark |
Lead Sponsor | Collaborator |
---|---|
Nordsjaellands Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of insensitivity towards cold | Measuring insensitivity towards cold using cutaneous application of a round, cooled glass container, stored in a refrigerator (5°C). The time of normal sensation is subtracted the time of onset. This non-invasive measurement is a well-established way to evaluate the presumed anaesthetic effect of LA. It will be performed in the cutaneous innervation of the common peroneal nerve and the sciatic nerve accordingly. It will be measured in hours. |
Until nerve block remission (expected to be less than 24 hours). | |
Secondary | Length of neural exposure to ropivacaine | Spread of ropivacaine along the common peroneal nerve and the sciatic nerve will be measured five times during the infusion of ropivacaine, using US. According to the volume to be infused, each of the five infusion groups will have a designated infusion-time. For each infusion, we will perform this measurement at each of these five calculated time points. Like this every participant will have a US scan five times. | During drug administration, no longer than 150 minutes. | |
Secondary | Time to onset of sensory nerve block | Time from start of infusion until first positive test, measured in minutes. | From start of infusion until onset of sensory nerve block or for no more than three hours | |
Secondary | Degree of motor nerve block | In an upright position and with a sturdy county as support, the degree of motor nerve block will be measured using a normal everyday activation of the lower leg; A toe and a heel raise, testing the common peroneal nerve via activation of the anterior tibial muscle and the tibial nerve via activation of the gastrocnemius muscle, respectively. | Until nerve block remission (expected to be less than 24 hours). |
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