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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-09

Study Completion Date

2018-04-12

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study is performed as a blinded, randomized, controlled study. Randomization will be based on a computer-generated block randomization list in a 1:1:1 ratio, block sizes of 9. A person, not otherwise involved in the study, will prepare the randomization list and keep it, locked away in a secure place. 2 sets of consecutively numbered, sealed, opaque, code envelopes will be prepared by the same person.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Please see "Model Description"

Study Groups

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Certa Catheter

A Certa-catheter (suture method) is inserted under ultrasound guidance at the midthigh level in the adductor canal, using an in plane technique, short/oblique axis view.

A bolus of ropivacaine will be administered during real time US imaging to ensure correct placement of the catheter (initial bolus). An infusion pump will be connected immediately following catheter insertion, delivering intermittent boluses every 8 hours until 12 pm on POD2.

2 dressings will be applied (medial and lateral) to obscure which catheter has been placed.

Group Type ACTIVE_COMPARATOR

Initial bolus (Certa and standard catheter groups)

Intervention Type 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.

Intermittent boluses (Certa and standard catheter groups)

Intervention Type DRUG

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

Standard Catheter

A Standard-catheter is inserted under ultrasound guidance at the midthigh level in the adductor canal, using an in plane technique, short/oblique axis view.

A bolus of ropivacaine will be administered during real time US imaging to ensure correct placement of the catheter (initial bolus). An infusion pump will be connected immediately following catheter insertion, delivering intermittent boluses every 8 hours until 12 pm on POD2.

2 dressings will be applied (medial and lateral) to obscure which catheter has been placed.

Group Type ACTIVE_COMPARATOR

Initial bolus (Certa and standard catheter groups)

Intervention Type 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.

Intermittent boluses (Certa and standard catheter groups)

Intervention Type DRUG

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

Single Bolus

A bolus of ropivacaine will be injected into the adductor canal, at the midthigh level, using a 80 mm x 22G Pajunk needle during real time US imaging (initial bolus).

A sham catheter (25 Certa and 25 standard catheters according to randomi-zation) will be fixed externally and covered by dressings as in the catheter groups groups (Certa and standard). Care will be taken to use approximately the same amount of time as used in the catheter groups (Certa and standard) An infusion pump will be connected immediately following catheter insertion, delivering intermittent boluses into the dressing every 8 hour until 12 PM on POD2.

Group Type ACTIVE_COMPARATOR

Initial bolus (Single bolus group)

Intervention Type DRUG

20 ml of ropivacaine 0.75%

Intermittent boluses (Single bolus group)

Intervention Type DRUG

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

Interventions

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Initial bolus (Certa and standard catheter groups)

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.

Intervention Type DRUG

Initial bolus (Single bolus group)

20 ml of ropivacaine 0.75%

Intervention Type DRUG

Intermittent boluses (Certa and standard catheter groups)

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

Intervention Type DRUG

Intermittent boluses (Single bolus group)

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No