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

NCT03142789 | Completed Phase 4 DMC

• 1 other identifier: EudraCT number: 2016-005069-30
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management

Keywords

Pain; Total knee arthroplasty; Regional anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• VAS (Visual analog scale) 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

  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)

  12 (noon) on POD 1 and 2

• TUG-test

  12 (noon) on POD 1 and 2

• 6 minutes walk test

  12 (noon) on POD 1 and 2

Other Outcomes (2)

• Catheter testing - temperature

  preoperatively and at 12 (noon) on POD 1 and 2

• Catheter testing - Ultrasound

  on POD 2 at 2 PM

Study Arms (3)

Certa Catheter

ACTIVE COMPARATOR

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); Drug: Intermittent boluses (Certa and standard catheter groups)

Standard Catheter

ACTIVE COMPARATOR

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); Drug: Intermittent boluses (Certa and standard catheter groups)

Single Bolus

ACTIVE COMPARATOR

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); Drug: Intermittent boluses (Single bolus group)

Interventions

Initial bolus (Certa and standard catheter groups) 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.

Certa Catheter; Standard Catheter

Initial bolus (Single bolus group) DRUG

20 ml of ropivacaine 0.75%

Single Bolus

Intermittent boluses (Certa and standard catheter groups) DRUG

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

Certa Catheter; Standard Catheter

Intermittent boluses (Single bolus group) DRUG

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

Single Bolus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

Gentofte Hospital

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 31465115 DERIVED

MeSH Terms

Conditions

Agnosia; Pain

Interventions

cerivastatin

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ulrik Grevstad, MD, phd

  Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Please see "Model Description"
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, phd

Model Details: 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.

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 5, 2017
• Study Start: May 9, 2017
• Primary Completion: April 12, 2018
• Study Completion: April 12, 2018
• Last Updated: May 1, 2018

Record last verified: 2018-04

Locations

DK (1)