Clinical trial NCT06514365: Comparison of the Analgesic Effect of Subsartorial Saphenous Block and Popliteal Sciatic vs Subsartorial Saphenous Block and IPACK in Total Knee Replacement Surgery.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Acute
Knee Osteoarthritis
Anesthesia
Keywords: Ipack
Block
Total knee replacement
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Pain at rest
timeFrame: 6 hours after surgery
measure: Pain at rest
timeFrame: 24 hours after surgery
measure: Pain at rest
timeFrame: 48 hours after surgery
measure: Pain at movement
timeFrame: 6 hours after surgery
measure: Pain with movement
timeFrame: 24 hours after surgery
measure: Pain with movement
timeFrame: 48 hours after surgery
measure: Motor block
timeFrame: 6 hours after surgery
measure: Motor block
timeFrame: 24 hours after surgery
measure: Motor block
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Opioids dose
timeFrame: 6 hours after surgery
measure: Opioids dose
timeFrame: 24 hours after surgery
measure: Opioids dose
timeFrame: 48 hours after surgery
measure: Discharge days
timeFrame: Days
measure: Patient satisfaction
timeFrame: 24 hours after surgery
measure: Ambulation time
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
Study officials:
References: