Catheter-based Peripheral Regional Anesthesia After Total Knee Arthroplasty (API-KNEE)

Catheter-based Peripheral Regional Anesthesia After Total Knee Arthroplasty: Comparison of Low Dose, Automated Periodic Infusions With Conventional High Dose, Continuous Infusion and Patient-initiated Infusions Only

BACKGROUND

Total knee arthroplasty can be severely painful, and peripheral regional anesthesia is highly recommended as part of the perioperative pain treatment. Whether catheter-based techniques are better than single injection techniques are debatable. Furthermore, in catheter-based techniques, whether a low-dose automated, periodic infusion can produce similar analgesic effectiveness compared to a conventional, high dose, continuous infusion has never been explored.

AIM Comparison of the analgesic effectiveness of a low-dose automated, periodic infusion, a conventional continuous infusion and patient-controlled boluses only in catheter-based adductor canal blocks for patients undergoing total knee arthrplasty.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Ropivacaine 0.2%

Detailed Description

BACKGROUND

Total knee arthroplasty (TKA) is a very common procedure, with more than 600.000 being performed annually in the US alone. This number is expected to increase to more than 3 million by 2030. The procedure is associated with intense, early postoperative pain, and half of the patients report moderate to severe pain the first 2-3 postoperative days (POD). Peripheral regional anesthesia (PRA) using single injection nerve blocks is highly recommended as part of a multimodal, perioperative, analgesic treatment.

Patients who are expected to have postoperative, severe pain exceeding the duration of a single injection nerve block may benefit from a catheter-based nerve block (CBNB) using either a continuous infusion (CI) or intermittent infusions of local anesthetics (LA). Intermittent boluses can be either patient-controlled or prescribed in combination with a continuous infusion or as prespecified intermittent boluses. Whether a CBNB treatment is superior to a single injection nerve block after orthopedic surgery remains unanswered. There are several challenges when using a CBNB treatment: The dosing or delivery method may be either insufficient and thus not pain relieving or too powerful resulting in dense motor block and limb anesthesia which may compromise safety and rehabilitation. The peripheral nerve block catheter may also displace and therefore deposit LA too far from the targeted nerve(s) to produce an effective nerve block.

Previous studies suggest that an automated periodic infusion (API) regimen is superior to CI. It seems that an API produces better pain control, a lower analgesic consumption over time and less motor inhibition. This is welldescribed for epidural catheters for laboring women, but evidence is also apparent in PRA. Adding a PCA bolus option to a catheter-based nerve block treatment may even out the difference in pain scores between API and CI.

However, it seems that API groups require less LA via PCA function. Reducing LA consumption is of great importance for ambulatory patients whose LA reservoir is limited, but also for all other orthopedic patients whose motor block should be minimized in order to optimize rehabilitation.

OBJECTIVES

To investigate whether a low-dose API with patient-controlled bolus option can produce a similar analgesic effect compared to a conventional, high dose, CI with patient-controlled bolus option in catheter-based peripheral nerve blocks for patients undergoing total knee arthrplasty.

Analgesic effectiveness will be compared with a group only given the patient controlled bolus option.

HYPOTHESIS

Low dose API with supplemental patient-controlled bolus option will provide pain-relieving therapy not inferior to a conventional CI with supplemental patient-controlled bolus option. The intervention group receiving patient-controlled boluses only will experience more pain breakthrough.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Hillerød, Denmark, DK-3400
    • Department of Anesthesiology, Nordsjællands Hospital Hillerød

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥ 18 years
2. American Society of Anesthesiologists Classification I-III
3. Normal cognitive function in order to sign written, informed consent and to understand trial protocol
4. Agreement to the trial protocol, including the randomized manner

Exclusion Criteria:

1. Allergy to LA
2. Infection in or near insertion site of the peripheral nerve catheter
3. Anatomical abnormalities preventing successful peripheral catheter insertion
4. Habitual use of opioids
5. Pregnancy or breastfeeding (disproved by a negative pregnancy test before trial inclusion)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: API+PCA; Infusion of ropivacaine 0.2 %, 15 mL, every 10th hour. Patient-initiated bolus of ropivacaine 0,2 %, 15 mL. Lock-out time: 5 hours.	Drug: Ropivacaine 0.2%; Perineural infusion using a peripheral nerve block catheter and a portable infusion pump.; Other Names: Naropin 0.2%
Active Comparator: CI+PCA; Continuous infusion of ropivacaine 0.2 %, 6 mL/hour. Patient-initiated bolus of ropivacaine 0,2 %, 15 mL. Lock-out time: 5 hours.	Drug: Ropivacaine 0.2%; Perineural infusion using a peripheral nerve block catheter and a portable infusion pump.; Other Names: Naropin 0.2%
Active Comparator: PCA only; Patient-initiated bolus of ropivacaine 0,2 %, 15 mL. Lock-out time: 5 hours.	Drug: Ropivacaine 0.2%; Perineural infusion using a peripheral nerve block catheter and a portable infusion pump.; Other Names: Naropin 0.2%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain, 1-72 hours postoperatively	Postoperative pain using the visual analogue pain scale (VAS, 0-100 milimetres). Measurements will be patient-reported.	1-72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption, 1-72 hours postoperatively	Tablets consumed during the period of investigation	1-72 hours
Volume of patient-initiated boluses, 1-72 hours postoperatively	Volume of ropivacaine 0.2 % (mL) used for patient-initiated boluses, 1-72 hours postoperatively	1-72 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid related side effects	Patient reported symptoms: dizziness, nausea, itching, constipation	1-72 hours
Pain at bolus request	Pain (VAS, 0-100 milimetres) at the time of patient-initiated bolus	1-72 hours
Motor nerve block	Degree of motor nerve block, defined by paresis or paralysis in the knee flexion	1-72 hours
Sensory nerve block	Insensitivity towards cold in the lateral aspects of the lower leg and beneath the foot. This will be recorded by the patient using a cold glass vial stored in a refrigator until its use	1-72 hours

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital
• Investigators: Study Director: Kai Henrik Wiborg Lange, DMSci, Department of Anesthesiology, Nordsjaellands Hospital & University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2017
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: December 10, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 13, 2017

Study Record Updates

• Last Update Posted (Actual): September 17, 2019
• Last Update Submitted That Met QC Criteria: September 14, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Peripheral regional anesthesia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: H-17021068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No