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

University Hospital, Gentofte, Copenhagen

Status and phase: Completed; Phase 4

Conditions: Pain Management

Treatments: Drug: Initial bolus (Single bolus group); Drug: Initial bolus (Certa and standard catheter groups); Drug: Intermittent boluses (Single bolus group); Drug: Intermittent boluses (Certa and standard catheter groups)

Study type: Interventional

Funder types: Other

Identifiers

NCT03142789

EudraCT number: 2016-005069-30

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 153 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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153 participants in 3 patient groups

Certa Catheter

Active Comparator group

Description:

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.

Treatment:

Drug: Intermittent boluses (Certa and standard catheter groups)

Drug: Initial bolus (Certa and standard catheter groups)

Standard Catheter

Active Comparator group

Description:

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.

Treatment:

Drug: Intermittent boluses (Certa and standard catheter groups)

Drug: Initial bolus (Certa and standard catheter groups)

Single Bolus

Active Comparator group

Description:

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.

Treatment:

Drug: Intermittent boluses (Single bolus group)

Drug: Initial bolus (Single bolus group)