Adductor Canal Block After Total Knee Replacement - a Suture-method Catheter vs a Standard Catheter vs a Single Bolus
Phase 4
Completed
- Conditions
- Pain Management
- Interventions
- Drug: Initial bolus (Certa and standard catheter groups)Drug: Initial bolus (Single bolus group)Drug: Intermittent boluses (Certa and standard catheter groups)Drug: Intermittent boluses (Single bolus group)
- Registration Number
- NCT03142789
- Lead Sponsor
- University Hospital, Gentofte, Copenhagen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Certa Catheter Initial bolus (Certa and standard catheter groups) 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. Certa Catheter Intermittent boluses (Certa and standard catheter groups) 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 Initial bolus (Certa and standard catheter groups) 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. Standard Catheter Intermittent boluses (Certa and standard catheter groups) 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 Initial bolus (Single bolus group) 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. Single Bolus Intermittent boluses (Single bolus group) 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
Trial Locations
- Locations (1)
Gentofte Hospital
🇩🇰Copenhagen, Denmark
Gentofte Hospital🇩🇰Copenhagen, Denmark