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Completed

NCT Number: NCT03372304

Catheter-based Peripheral Regional Anesthesia After Orthopedic Surgery to the Foot or Ankle

BACKGROUND

Orthopedic surgery 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 nerve blocks for patients undergoing orthopedic surgery to the foot or ankle.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology, Nordsjællands Hospital Hillerød

Hillerød, DK-3400, Denmark

About this study

BACKGROUND

Orthopedic surgery has been reported to be moderate to severely painful in approximately 50 % of patients.

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 well-described 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 orthopedic surgery to the foot or ankle. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Ropivacaine 0.2%

Drug

Perineural infusion of Ropivacaine 0.2% using a peripheral nerve block catheter and a portable infusion pump.

Other names: Naropin 0.2%

Primary outcomes

  1. Postoperative pain, 1-72 hours postoperatively

    Time frame: 1-72 hours

    Postoperative pain using the visual analogue pain scale (VAS, 0-100 milimetres). Measurements will be patient-reported.

Secondary outcomes

  1. Opioid consumption, 1-72 hours postoperatively

    Time frame: 1-72 hours

    Tablets consumed during the period of investigation

  2. Volume of patient-initiated boluses, 1-72 hours postoperatively

    Time frame: 1-72 hours

    Volume of ropivacaine 0.2 % (mL) used for patient-initiated boluses, 1-72 hours postoperatively

Other outcomes

  1. Opioid related side effects

    Time frame: 1-72 hours

    Patient reported symptoms: dizziness, nausea, itching, constipation

  2. Pain at bolus request

    Time frame: 1-72 hours

    Pain (VAS, 0-100 milimetres) at the time of patient-initiated bolus

  3. Motor nerve block

    Time frame: 1-72 hours

    Degree of motor nerve block, defined by paresis or paralysis in the ankle dorsi- and plantarflexion movement.

  4. Sensory nerve block

    Time frame: 1-72 hours

    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 refrigerator until its use.

Sponsors and collaborators

Lead sponsor

Nordsjaellands Hospital

Other

Collaborators

  • Innovation Fund Denmark

Registry information

Official study title

Catheter-based Peripheral Regional Anesthesia After Orthopedic Surgery to the Foot or Ankle: Comparison of Low Dose, Automated Periodic Infusions With Conventional High Dose, Continuous Infusion, and Patient-initiated Infusions Only

Acronym: API-FOOT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 13, 2017
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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