NCT03142789

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: University Hospital, Gentofte, Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Pain Management

Interventions

Type	Name	Description
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	Initial bolus (Single bolus group)	20 ml of ropivacaine 0.75%
DRUG	Intermittent boluses (Certa and standard catheter groups)	20 ml of ropivacaine 0.2% every 8 hour in the catheter
DRUG	Intermittent boluses (Single bolus group)	0.1ml of ropivacaine 0.2% every 8 hour in the sham catheter

Timeline

• Start date: 2017-05-09
• Primary completion: 2018-04-12
• Completion: 2018-04-12
• First posted: 2017-05-05
• Last updated: 2018-05-01

Locations

1 site across 1 country: Denmark