Effects of Local Anaesthetic Infusion Rates on Nerve Block Duration

NCT02801799 | Terminated Phase 1 DMC

• 1 other identifier: FIPRA 1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Other Acute Postoperative Pain; Pain, Postoperative; Anaesthesia

Keywords

Anaesthesia; Analgesia; Nerve blocks; Peripheral nerve blocks; Regional anaesthesia; therapeutic techniques; ropivacaine; nerve block duration; lower limb; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Length of neural exposure to ropivacaine

  During drug administration, no longer than 150 minutes.

• Time to onset of sensory nerve block

  From start of infusion until onset of sensory nerve block or for no more than three hours

• Degree of motor nerve block

  Until nerve block remission (expected to be less than 24 hours).

Study Arms (5)

Infusion group 1

ACTIVE COMPARATOR

Intervention: One peri-neural infusion of a fixed volume of ropivacaine 0.2%, administered via a perineurial nerve catheter. Infusion rate will be 12 mL/h. This infusion rate is normal clinical practice when administering a perineural infusion of ropivacaine.

Drug: Varying infusion rates of Ropivacaine 0.2%

Infusion group 2

EXPERIMENTAL

Intervention: One peri-neural infusion of a fixed volume of ropivacaine 0.2%, administered via a perineurial nerve catheter. Infusion rate will be 60 mL/h. This infusion rate is experimental.

Drug: Varying infusion rates of Ropivacaine 0.2%

Infusion group 3

EXPERIMENTAL

Intervention: One peri-neural infusion of a fixed volume of ropivacaine 0.2%, administered via a perineurial nerve catheter. Infusion rate will be 300 mL/h. This infusion rate is experimental.

Drug: Varying infusion rates of Ropivacaine 0.2%

Infusion group 4

EXPERIMENTAL

Intervention: One peri-neural infusion of a fixed volume of ropivacaine 0.2%, administered via a perineurial nerve catheter. Infusion rate will be 600 mL/h. This infusion rate is experimental.

Drug: Varying infusion rates of Ropivacaine 0.2%

Infusion group 5

ACTIVE COMPARATOR

Intervention: One peri-neural infusion of a fixed volume of ropivacaine 0.2%, administered via a perineurial nerve catheter. Infusion rate will be 1800 mL/h. This infusion rate is normal clinical practice when administering a perineural bolus of ropivacaine.

Drug: Varying infusion rates of Ropivacaine 0.2%

Interventions

Varying infusion rates of Ropivacaine 0.2% DRUG

Participants will receive one nerve catheter adjacent to the common peroneal nerve (trial day 1) and adjacent to the sciatic nerve (trial day 2). Each catheter will be randomly allocated to one of five infusion groups. All peroneal nerve catheters will receive the same volume of ropivacaine 0.2%. All the sciatic nerve catheters will receive the same volume of ropivacaine 0.2%. The only inter-group variable will be the infusion rate. The fixed volume of ropivacaine will be determined in a separate study ('The Volume Study'), which is also part of the project: 'A novel technique for reliable, precise and safe postoperative management'. The largest volumes tested in "The Volume Study" are 30 mL for the sciatic nerve and 20 mL for the common peroneal nerve. Therefore the highest volume for the two intervention days cannot exceed 30 mL (150 mg of ropivacaine). We will ensure constant infusion rate and precise delivery of LA by using an electronic infusion pump and a nerve catheter.

Infusion group 1; Infusion group 2; Infusion group 3; Infusion group 4; Infusion group 5

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 of age
• ASA classification17 ≤ II

You may not qualify if:

• BMI ≤ 18 or ≥ 30 kg/m2
• Body weight ≤ 37.5 kg
• Former surgery to the lower extremities
• Peripheral nerve disease, including polyneuropathy and diabetes
• Allergy to local anaesthetics
• 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 Certa Catheter™ insertion.

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (1)

Research Unit, Department of Anaesthesiology and Intensive Care, Nordsjaellands Hospital Hilleroed

Hilleroed, Capital Region of Denmark, 3400, Denmark

Location

Related Publications (1)

• Madsen MH, Christiansen CB, Rothe C, Andreasen AM, Lundstrom LH, Lange KHW. Local Anesthetic Injection Speed and Common Peroneal Nerve Block Duration: A Randomized Controlled Trial in Healthy Volunteers. Reg Anesth Pain Med. 2018 Jul;43(5):467-473. doi: 10.1097/AAP.0000000000000759.

  PMID: 29570501 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Mikkel H. Madsen, MD

  Research Unit, Department of Anaesthesiology and Intensive Care, Nordsjaellands Hospital Hilleroed

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2016
• First Posted: June 16, 2016
• Study Start: October 10, 2016
• Primary Completion: November 23, 2016
• Study Completion: December 9, 2016
• Last Updated: March 30, 2017

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)