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NCT Number: NCT03142789

Adductor Canal Block After Total Knee Replacement - a Suture-method Catheter vs a Standard Catheter vs a Single Bolus

In this study we wish to investigate the analgesic effect of the administration of 0.2% ropivacaine for an adductor canal block as repeated boluses (20 ml every 8 hours) through a new suture-method catheter or a standard perineural catheter compared with a single bolus (20 ml), in patients following primary total knee arthroplasty.

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Key information

Conditions

Pain Management Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gentofte Hospital

Copenhagen, 2100, Denmark

About this study

The aim of the study is to compare the clinical effects of three different administration forms for an ACB: repeated intermittent boluses through a Certa catheter (CC) versus repeated boluses through a standard catheter (through the needle) (SC) versus a single bolus (SB). Our dual hypothesis is that repeated boluses through a catheter (either Certa or standard catheter) reduces opioid consumption (primary outcome), as well as reduces pain scores, enhances ambulation and muscle strength compared with a single bolus, and that the Certa catheter is superior to a standard catheter.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients scheduled for unilateral total knee arthroplasty in spinal anesthesia
  • Patients who gave their written informed consent to participating in the study after having fully understood the contents of the protocol and restrictions
  • ASA 1-3
  • Ability to perform a TUG test preoperatively

Exclusion criteria

  • Patients who cannot cooperate
  • Patients who cannot understand or speak Danish.
  • Patients with allergy to the medicines used in the study
  • Patients with a daily intake of strong opioids (morphine, oxycodone, ketobemidone, methadone, fentanyl) during the last 4 weeks
  • Patients suffering from alcohol and/or drug abuse - based on the investigator's assessment
  • Rheumatoid arthritis
  • BMI > 40
  • Neuromuscular pathology in the lower limbs
  • Pregnancy

Treatment and study plan

Initial bolus (Certa and standard catheter groups)

Drug

10 ml of ropivacaine 0,75% will be used to ensure correct position of the needle and to expand the adductor canal, followed by injection of another 10 ml of ropivacaine 0.75% via the catheter during real time US imaging to ensure correct placement of the catheter.

Initial bolus (Single bolus group)

Drug

20 ml of ropivacaine 0.75%

Intermittent boluses (Certa and standard catheter groups)

Drug

20 ml of ropivacaine 0.2% every 8 hour in the catheter

Intermittent boluses (Single bolus group)

Drug

0.1ml of ropivacaine 0.2% every 8 hour in the sham catheter

Primary outcomes

  1. Total opioid consumption

    Time frame: from end of surgery until 12 (noon) on POD 2 (Postoperative Day)

    • Total opioid consumption (PCA pump and any potential rescue administration) between groups (SB vs CC, SB vs SC and CC vs SC)

Secondary outcomes

  1. VAS (Visual analog scale) flexion

    Time frame: o Pain is recorded preoperatively before administration of medication, and postoperatively at the PACU (Postoperative Care Unit), at 8 PM on the day of surgery, at 8 AM, 12 (noon) and 8 PM on POD 1 and finally at 8 AM and 12 (noon) on POD 2.

    VAS pain score (0-100mm) during 45 degrees active knee flexion

  2. VAS rest

    Time frame: o Pain is recorded preoperatively before administration of medication, and postoperatively at the PACU, at 8 PM on the day of surgery, at 8 AM, 12 (noon) and 8 PM on POD 1 and finally at 8 AM and 12 (noon) on POD 2.

    VAS pain score (0-100mm) during rest

  3. VAS-TUG (Time-Up-and-Go-Test)

    Time frame: 12 (noon) on POD 1 and 2

    Worst VAS pain score (0-100mm) during Timed-Up-and-Go test

  4. TUG-test

    Time frame: 12 (noon) on POD 1 and 2

    Timed-Up-and-Go test

  5. 6 minutes walk test

    Time frame: 12 (noon) on POD 1 and 2

    How many meters the patient can walk (using a high 4-wheel walker) in 6 minutes

  6. MVIC (Maximum Voluntary Isometric Contraction)

    Time frame: Preoperatively and at 12 (noon) on POD 1 and 2

    Quadriceps strength assessed as maximum voluntary isometric contraction in percentage of preoperative baseline values.

  7. TUG test, patient number

    Time frame: 12 (noon) on POD 1 and 2

    Number of patients able to perform the TUG test using a high 4-wheel walker

Other outcomes

  1. Catheter testing - temperature

    Time frame: preoperatively and at 12 (noon) on POD 1 and 2

    Using an alcohol swab we will test for temperature discrimination ability in the saphenous distribution area

  2. Catheter testing - Ultrasound

    Time frame: on POD 2 at 2 PM

    At the end of the study period all patients will have an US evaluation of the catheters (a sham evaluation in the SB group) by one of the unblinded investigators. 20 ml of ropivacaine 0.2% will be injected during real-time US visualization. Spread outside the canal will be noted. In case the patient has a displaced catheter repositioning will be attempted, whether repositioning is possible is noted on a separate CRF (Case Report Form). The following will be noted; is the orifice of the catheter visible (yes/no), does injection result in a spread in-side the adductor canal (yes/no), can the catheter be repositioned to obtain a spread inside the canal (yes/no).

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Official study title

Comparison of the Analgesic Effect of an ACB (Adductor Canal Block) Using a New Suture-method Catheter vs a Standard Perineural Catheter vs a Single Bolus: A Randomized, Blinded, Controlled Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 5, 2017
Registry last updated
May 1, 2018

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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