Catheter-based Peripheral Regional Anesthesia After Total Knee Arthroplasty

NCT ID: NCT03372265

Last Updated: 2019-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-06
• Study Completion Date: 2019-04-01

Brief Summary

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.

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ropivacaine 0.2%

Intervention Type: DRUG

Perineural infusion using a peripheral nerve block catheter and a portable infusion pump.

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.

Group Type: ACTIVE_COMPARATOR

Ropivacaine 0.2%

Intervention Type: DRUG

Perineural infusion using a peripheral nerve block catheter and a portable infusion pump.

PCA only

Patient-initiated bolus of ropivacaine 0,2 %, 15 mL. Lock-out time: 5 hours.

Group Type: ACTIVE_COMPARATOR

Ropivacaine 0.2%

Intervention Type: DRUG

Perineural infusion using a peripheral nerve block catheter and a portable infusion pump.

Interventions

Ropivacaine 0.2%

Perineural infusion using a peripheral nerve block catheter and a portable infusion pump.

Intervention Type: DRUG

Other Intervention Names

Naropin 0.2%

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nordsjaellands Hospital

OTHER

Sponsor Role: lead

Responsible Party

Claus Behrend Christiansen

Medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kai Henrik Wiborg Lange, DMSci

Role: STUDY_DIRECTOR

Department of Anesthesiology, Nordsjaellands Hospital & University of Copenhagen

Locations

Department of Anesthesiology, Nordsjællands Hospital Hillerød

Hillerød, , Denmark

Countries

Denmark

Other Identifiers

H-17021068

Identifier Type: -

Identifier Source: org_study_id