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

Pain Management Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03142789
• Other study ID #: EudraCT number: 2016-005069-30
• Status: Completed
• Phase: Phase 4
• Start date: May 9, 2017
• Est. completion date: April 12, 2018

Study information

• Verified date: April 2018
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: April 12, 2018
• Est. primary completion date: April 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain Management

Intervention

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

Locations

Country	Name	City	State
Denmark	Gentofte Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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.
Secondary	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.
Secondary	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
Secondary	TUG-test	Timed-Up-and-Go test	12 (noon) on POD 1 and 2
Secondary	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
Secondary	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
Secondary	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