Comparison of different treatment modalities in peripheral nerve block catheter-based pain treatment after orthopaedic surgery.

Catheter-based peripheral regional anaesthesia after orthopaedic surgery: Comparison of low dose, automated periodic infusions with conventional high dose, continuous infusion, and patient-initiated infusions only. A non-inferiority, randomised, controlled trial. - Focus on Infusion in Peripheral Regional Anaesthesia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002280-18-DK

Enrollment

270

Registered

2017-07-10

Start date

2017-09-18

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain, after orthopaedic surgery. MedDRA version: 20.0 Level: PT Classification code 10029173 Term: Nerve block System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Ropivacaine "Fresenius Kabi" 0.2% Product Name: Ropivacaine "Fresenius Kabi" 0.2% Product Code: 26616 Pharmaceutical Form: Solution for inje

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Substudy one: 1. =18 years of age 2. Scheduled for elective shoulder arthroplasty, rotator cuff repair, or Bankart operation 3. ASA classification24 = III 4. Agreement to the trial protocol Substudy two: 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 Substudy three: 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90

Exclusion criteria

Exclusion criteria: Substudy one: 1. Body weight = 50 kg 2. Allergy to local anaesthetics 3. Mental or cognitive disease that impede compliance 4. Contraindication of interscalene brachial plexus nerve block (i.e. pneumothorax, severe pulmonary disease) 5. Anatomic abnormalities preventing successful US-guided Certa Catheter™ insertion. 6. Pregnancy or breastfeeding Substudy two and three: 1) Allergy to LA 2) Infection in or near insertion site of the peripheral nerve catheter 3) Habitual use of opioids 4) Pregnancy or breastfeeding

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of this trial is to investigate whether a low-dose automated, periodic infusion can produce a similar analgesic effect compared to a conventional, high dose, continuous infusion in catheter-based nerve block treatment for patients undergoing orthopaedic surgery. This is exemplified in three sub-trials on different populations: 1: Patients undergoing major shoulder surgery 2: Patients undergoing foot or ankle surgery 3: Patients undergoing major knee surgery ; Secondary Objective: 1: To investigate whether a low-dose automated, periodic infusion can produce a similar analgesic effect compared to a conventional, high dose, continuous infusion in catheter-based nerve block treatment for patients undergoing major shoulder surgery. 2: To investigate whether a low-dose automated, periodic infusion can produce a similar analgesic effect compared to a conventional, high dose, continuous infusion in catheter-based nerve block treatment for patients undergoing surgery of the foot or ankle. 3: To investigate whether a low-dose automated, periodic infusion can produce a similar analgesic effect compared to a conventional, high dose, continuous infusion in catheter-based nerve block treatment for patients undergoing major knee surgery. ; Primary end point(s): AUC for pain during 72 h postoperatively, measured with a numerical rating pain score (NRPS) ; Timepoint(s) of evaluation of this end point: During the first 72 hours post-operatively, we will gather information on each participants level of pain. At the end of the trial the pain scores will be translated into the AUC value.	—

Measure

Time frame

Main Objective: The purpose of this trial is to investigate whether a low-dose automated, periodic infusion can produce a similar analgesic effect compared to a conventional, high dose, continuous infusion in catheter-based nerve block treatment for patients undergoing orthopaedic surgery. This is exemplified in three sub-trials on different populations: 1: Patients undergoing major shoulder surgery 2: Patients undergoing foot or ankle surgery 3: Patients undergoing major knee surgery ; Secondary Objective: 1: To investigate whether a low-dose automated, periodic infusion can produce a similar analgesic effect compared to a conventional, high dose, continuous infusion in catheter-based nerve block treatment for patients undergoing major shoulder surgery. 2: To investigate whether a low-dose automated, periodic infusion can produce a similar analgesic effect compared to a conventional, high dose, continuous infusion in catheter-based nerve block treatment for patients undergoing surgery of the foot or ankle. 3: To investigate whether a low-dose automated, periodic infusion can produce a similar analgesic effect compared to a conventional, high dose, continuous infusion in catheter-based nerve block treatment for patients undergoing major knee surgery. ; Primary end point(s): AUC for pain during 72 h postoperatively, measured with a numerical rating pain score (NRPS) ; Timepoint(s) of evaluation of this end point: During the first 72 hours post-operatively, we will gather information on each participants level of pain. At the end of the trial the pain scores will be translated into the AUC value.

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Opioid consumption and volume of LA is evaluated after the 72 hour period. AUC for pain during active knee flexion is calculated from values gathered during the 72 hour period. ; Secondary end point(s): Substudy one and two: • Opioid consumption during 72 h postoperatively • Volume of PCA administered LA during 72 h postoperatively Substudy three: 1. Opioid consumption during 72 h postoperatively 2. Volume of PCA administered LA during 72 h postoperatively 3. AUC for pain (NRPS) during active knee flexion during 72 h postoperatively.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Opioid consumption and volume of LA is evaluated after the 72 hour period. AUC for pain during active knee flexion is calculated from values gathered during the 72 hour period. ; Secondary end point(s): Substudy one and two: • Opioid consumption during 72 h postoperatively • Volume of PCA administered LA during 72 h postoperatively Substudy three: 1. Opioid consumption during 72 h postoperatively 2. Volume of PCA administered LA during 72 h postoperatively 3. AUC for pain (NRPS) during active knee flexion during 72 h postoperatively.

—

Countries

Denmark

Contacts

Public ContactThe Department of Anesthesiology

Nordsjællands Hospital Hillerød

mhmadsen@gmail.com+4548296680

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026