Clinical trial NCT03142789: Adductor Canal Block After Total Knee Replacement - a Suture-method Catheter vs a Standard Catheter vs a Single Bolus
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain Management
Keywords: Pain
Total knee arthroplasty
Regional anesthesia
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total opioid consumption
timeFrame: from end of surgery until 12 (noon) on POD 2 (Postoperative Day)
Secondary outcomes:
measure: VAS (Visual analog scale) flexion
timeFrame: 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.
measure: VAS rest
timeFrame: 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.
measure: VAS-TUG (Time-Up-and-Go-Test)
timeFrame: 12 (noon) on POD 1 and 2
measure: TUG-test
timeFrame: 12 (noon) on POD 1 and 2
measure: 6 minutes walk test
timeFrame: 12 (noon) on POD 1 and 2
measure: MVIC (Maximum Voluntary Isometric Contraction)
timeFrame: Preoperatively and at 12 (noon) on POD 1 and 2
measure: TUG test, patient number
timeFrame: 12 (noon) on POD 1 and 2
Other outcomes:
measure: Catheter testing - temperature
timeFrame: preoperatively and at 12 (noon) on POD 1 and 2
measure: Catheter testing - Ultrasound
timeFrame: on POD 2 at 2 PM
Locations:
city: Copenhagen
country: Denmark
facility: Gentofte Hospital
Study officials:
affiliation: Gentofte Hospital
name: Ulrik Grevstad, MD, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.