Pain Management
Conditions
Keywords
Pain, Total knee arthroplasty, Regional anesthesia
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.
Interventions
DRUGInitial 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.
DRUGInitial bolus (Single bolus group)
20 ml of ropivacaine 0.75%
DRUGIntermittent boluses (Certa and standard catheter groups)
20 ml of ropivacaine 0.2% every 8 hour in the catheter
DRUGIntermittent boluses (Single bolus group)
0.1ml of ropivacaine 0.2% every 8 hour in the sham catheter
Sponsors
University Hospital, Gentofte, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Please see Model Description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total opioid consumption | from end of surgery until 12 (noon) on POD 2 (Postoperative Day) | • Total opioid consumption (PCA pump and any potential rescue administration) between groups (SB vs CC, SB vs SC and CC vs SC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 pain score (0-100mm) during 45 degrees active knee flexion |
| 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 pain score (0-100mm) during rest |
| VAS-TUG (Time-Up-and-Go-Test) | 12 (noon) on POD 1 and 2 | Worst VAS pain score (0-100mm) during Timed-Up-and-Go test |
| TUG-test | 12 (noon) on POD 1 and 2 | Timed-Up-and-Go test |
| MVIC (Maximum Voluntary Isometric Contraction) | Preoperatively and at 12 (noon) on POD 1 and 2 | Quadriceps strength assessed as maximum voluntary isometric contraction in percentage of preoperative baseline values. |
| TUG test, patient number | 12 (noon) on POD 1 and 2 | Number of patients able to perform the TUG test using a high 4-wheel walker |
| 6 minutes walk test | 12 (noon) on POD 1 and 2 | How many meters the patient can walk (using a high 4-wheel walker) in 6 minutes |
Other
| Measure | Time frame | Description |
|---|---|---|
| Catheter testing - temperature | preoperatively and at 12 (noon) on POD 1 and 2 | Using an alcohol swab we will test for temperature discrimination ability in the saphenous distribution area |
| Catheter testing - Ultrasound | on POD 2 at 2 PM | 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). |
Countries
Denmark
Outcome results
None listed