Clinical trial

Comparison of the Analgesic Effect of Subsartorial Saphenous Block and Popliteal Sciatic vs Subsartorial Saphenous Block and IPACK in Total Knee Replacement Surgery. A Double Blind Randomized Clinical Trial.

Aliases
IPACK-20, NCT06514365
Name
IPACK-20
Description
Total knee replacement surgery is associated with significant pain in the immediate postoperative period, especially in movement. In turn, this is associated with more subsequent chronic pain. There are multiple options and the tendency is to perform increasingly distal nerve blocks to minimize limb weakness and thus allow early rehabilitation. In 2012, in an oral communication, Sanjay Sinha described a new nerve block called iPACK ("Interspace between the Popliteal Artery and the Capsule of the posterior Knee"). There are few studies on the efficacy of such a blockade so far, but none comparing the groups saphene + sciatic blocks vs. saphene + iPACK blocks. Therefore, this study aims to provide more information on the effectiveness this nerve blocks, in total knee replacement, in terms of analgesia and motor function.
Trial arms
Trial start
2020-06-10
Estimated PCD
2024-06-01
Trial end
2024-08-01
Status
Recruiting
Treatment
IPACK block with Bupivacaine 0.25% with adrenaline
The iPACK in performed in the popliteal fossa about 1 finger breath above the patella, ecoguided. That aims to anesthetize the articular branches to the posterior aspect of the knee in the popliteal region.
Arms:
Echo-guided IPACK block, Echo-guided sciatic block
Other names:
Interspace between the Popliteal Artery and the Capsule of the posterior Knee
Size
62
Primary endpoint
Pain at rest
6 hours after surgery
Pain at rest
24 hours after surgery
Pain at rest
48 hours after surgery
Pain at movement
6 hours after surgery
Pain with movement
24 hours after surgery
Pain with movement
48 hours after surgery
Motor block
6 hours after surgery
Motor block
24 hours after surgery
Motor block
48 hours after surgery
Eligibility criteria
Inclusion Criteria: * Patients with osteoarthritis scheduled for total primary knee arthroplasty with same surgeons * Locoregional anesthesia * Age equal to or greater than 18 years * Consent to participate in the study Exclusion Criteria: * Age under 18 years old * General anesthesia * Allergy to local anesthetics * Severe kidney failure (Cr ≥ 2mg / dL) * Chronic opioid use (over 3 months) * Chronic pregabalin / gabapentin use (more than 3 months) * Psychiatric illness that may interfere with the evaluation or follow-up
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 62, 'type': 'ESTIMATED'}}
Updated at
2024-07-23

1 organization

1 product

4 indications

Indication
Pain
Indication
Acute
Indication
Anaesthesia