A Phase 2 interventional study of Adductor Canal Block plus IPACK Block and Adductor Canal Block in Total Knee Arthroplasty, sponsored by Asklepieion Voulas General Hospital. Status unknown at 1 site in Greece. Open to participants aged 14 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-10-22.
Sponsored by Asklepieion Voulas General Hospital · Phase 2, Interventional, and Treatment
100 patients ASA I-III, undergoing total knee arthroplasty under spinal anesthesia, will be randomly assigned into one of two groups, namely group A (n=50), where an adductor canal block and an IPACK block will be performed preoperatively and group B (n=50) where an adductor canal block only will be performed preoperatively. All patients will receive a standardized multimodal approach, including pregabalin, paracetamol, and PCA with morphine. NRS scores in static and dynamic conditions during the first 48 hours postoperatively, morphine consumption during the first 24 hours postoperatively will be measured and additionally, patient satisfaction, complications, range of knee motion, moblization, functionality, delirium ocurence will be recorded. Chronic pain will be assessed in 3 and 6 months postoperatively.
Asklepieion Voulas General Hospital is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Adductor Canal Block plus IPACK Block
Drug: Adductor Canal Block
Adductor Canal Block plus IPACK Block using Ropivacaine
Adductor Canal Block using Ropivacaine
NRS scores
Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)
Time frame: 48 hours
Morphine consumption
Morphine consumption in mg
Time frame: 24 hours
Chronic pain
Using of Graded Chronic Pain Scale (GCPS) Grade 0: No pain in prior 6 months Grade 1: Low Intensity - Low Disability Grade II: High Intensity Characteristic Pain Intensity - Low Disability Grade III: High Disability - Moderately Limiting Grade IV: High Disability - Severely Limiting
Time frame: 6 months
Delirium occurence
Nu-DESK scale (presence of disorientation, inappropriate behavior, inappropriate communication,illusions/hallucinations, psychomoter retardation). Each of the 5 items is rated from 0 to 2. A total of 10 is the maximum score. A score of more than 2 identifies the presence of delirium.
Time frame: 48 hours
Range of knee motion
Degrees of flexion
Time frame: 48 hours
Complications
Time frame: 48 hours
Patient mobilization
Patient reporting time of first standing to the side of the bed and number of steps per day
Time frame: 5 days
Patient satisfaction
Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No
Time frame: 48 hours
Joint function
Maximal flexion / extension
Time frame: 6 months
Intestinal function
Time of first passing of rectal gas, reported by the patient
Time frame: 5 days
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Asklepieion Voulas General Hospital