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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrik Grevstad, MD, phd | Gentofte Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gentofte Hospital | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31465115 | Derived | 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. |
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We have not yet decided whether IPD will be made available to other researchers
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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.
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Please see "Model Description"
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| Initial bolus (Single bolus group) | Drug | 20 ml of ropivacaine 0.75% |
|
| Intermittent boluses (Certa and standard catheter groups) | Drug | 20 ml of ropivacaine 0.2% every 8 hour in the catheter |
|
| Intermittent boluses (Single bolus group) | Drug | 0.1ml of ropivacaine 0.2% every 8 hour in the sham catheter |
|
| 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 |
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 |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C086276 | cerivastatin |
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