Catheter-based Peripheral Regional Anesthesia After Total Knee Arthroplasty

NCT03372265 | Completed Phase 4 DMC

• 1 other identifier: H-17021068
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Peripheral regional anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Opioid consumption, 1-72 hours postoperatively

  1-72 hours

• Volume of patient-initiated boluses, 1-72 hours postoperatively

  1-72 hours

Other Outcomes (4)

• Opioid related side effects

  1-72 hours

• Pain at bolus request

  1-72 hours

• Motor nerve block

  1-72 hours

Study Arms (3)

API+PCA

EXPERIMENTAL

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%

CI+PCA

ACTIVE COMPARATOR

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%

PCA only

ACTIVE COMPARATOR

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

Drug: Ropivacaine 0.2%

Interventions

Ropivacaine 0.2% DRUG

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

Also known as: Naropin 0.2%

API+PCA; CI+PCA; PCA only

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Allergy to LA
• Infection in or near insertion site of the peripheral nerve catheter
• Anatomical abnormalities preventing successful peripheral catheter insertion
• Habitual use of opioids

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (1)

Department of Anesthesiology, Nordsjællands Hospital Hillerød

Hillerød, DK-3400, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Kai Henrik Wiborg Lange, DMSci

  Department of Anesthesiology, Nordsjaellands Hospital & University of Copenhagen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All patients and outcome assessors will be blinded to the delivery administrations. Investigators will not be present while programming of the infusion pump is taking place. The display of the infusion pump will be concealed at all times after initiation. Furthermore, throughout the trial, the infusion pump will be concealed from the patient through a non-transparent bag. Trial interventions will not be visible in electronic patient charts. The infusion pump is making a discrete noise when administering medications. To make sure that the PCA group and the continuous infusion group is blinded to interventions, a sham administration is activated every 10th hour. This sham administration will be 0.1 mL of ropivacaine 0.2%. Such a small dose of LA will not have any anesthetic effect nor pose a risk for the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Model Details: 3 arms (API, CI and PCA only)

Study Record Dates

• First Submitted: December 10, 2017
• First Posted: December 13, 2017
• Study Start: December 6, 2017
• Primary Completion: February 1, 2019
• Study Completion: April 1, 2019
• Last Updated: September 17, 2019

Record last verified: 2019-09

Locations

DK (1)