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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain Management
• Intervention / Treatment: Drug: Initial bolus (Certa and standard catheter groups); Drug: Intermittent boluses (Certa and standard catheter groups); Drug: Initial bolus (Single bolus group); Drug: Intermittent boluses (Single bolus group)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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.; Drug: Intermittent boluses (Certa and standard catheter groups); 20 ml of ropivacaine 0.2% every 8 hour in the catheter
Active Comparator: 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.	Drug: 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.; Drug: Intermittent boluses (Certa and standard catheter groups); 20 ml of ropivacaine 0.2% every 8 hour in the catheter
Active Comparator: 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.	Drug: Initial bolus (Single bolus group); 20 ml of ropivacaine 0.75%; Drug: Intermittent boluses (Single bolus group); 0.1ml of ropivacaine 0.2% every 8 hour in the sham catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total opioid consumption	• Total opioid consumption (PCA pump and any potential rescue administration) between groups (SB vs CC, SB vs SC and CC vs SC)	from end of surgery until 12 (noon) on POD 2 (Postoperative Day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS (Visual analog scale) flexion	VAS pain score (0-100mm) during 45 degrees active knee flexion	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 rest	VAS pain score (0-100mm) during rest	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-TUG (Time-Up-and-Go-Test)	Worst VAS pain score (0-100mm) during Timed-Up-and-Go test	12 (noon) on POD 1 and 2
TUG-test	Timed-Up-and-Go test	12 (noon) on POD 1 and 2
6 minutes walk test	How many meters the patient can walk (using a high 4-wheel walker) in 6 minutes	12 (noon) on POD 1 and 2
MVIC (Maximum Voluntary Isometric Contraction)	Quadriceps strength assessed as maximum voluntary isometric contraction in percentage of preoperative baseline values.	Preoperatively and at 12 (noon) on POD 1 and 2
TUG test, patient number	Number of patients able to perform the TUG test using a high 4-wheel walker	12 (noon) on POD 1 and 2

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Catheter testing - temperature	Using an alcohol swab we will test for temperature discrimination ability in the saphenous distribution area	preoperatively and at 12 (noon) on POD 1 and 2
Catheter testing - Ultrasound	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).	on POD 2 at 2 PM

Collaborators and Investigators

• Sponsor: University Hospital, Gentofte, Copenhagen
• Investigators: Principal Investigator: Ulrik Grevstad, MD, phd, Gentofte Hospital

Publications and helpful links

General Publications

• Lyngeraa TS, Jaeger P, Gottschau B, Graungaard B, Rossen-Jorgensen AM, Toftegaard I, Grevstad U. Comparison of the analgesic effect of an adductor canal block using a new suture-method catheter vs. standard perineural catheter vs. single-injection: a randomised, blinded, controlled study. Anaesthesia. 2019 Nov;74(11):1397-1405. doi: 10.1111/anae.14814. Epub 2019 Aug 29.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2017
• Primary Completion (Actual): April 12, 2018
• Study Completion (Actual): April 12, 2018

Study Registration Dates

• First Submitted: May 1, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (Actual): May 5, 2017

Study Record Updates

• Last Update Posted (Actual): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Pain; Total knee arthroplasty; Regional anesthesia
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Cerivastatin
• Other Study ID Numbers: EudraCT number: 2016-005069-30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We have not yet decided whether IPD will be made available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No