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Comparison of the Analgesic Effect of Subsartorial Saphenous Block and Popliteal Sciatic vs Subsartorial Saphenous Block and IPACK in Total Knee Replacement Surgery.

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.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06514365
Enrollment
62
Registered
2024-07-23
Start date
2020-06-10
Completion date
2024-08-01
Last updated
2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Knee Osteoarthritis, Pain, Acute

Keywords

Ipack, Block, Total knee replacement

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.

Interventions

DRUGIPACK 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.

Sponsors

Germans Trias i Pujol Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Motor block6 hours after surgeryMeasured on a scale of 3, where 0 = no motor block, 1 = partial motor block and 2 = complete motor block. It will be performed on plantar flexion (distribution of the tibial nerve) and dorsiflexion (peroneal distribution)).
Pain at movement6 hours after surgeryMeasured by the numerical visual scale at 48 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.
Pain at rest6 hours after surgeryMeasured by the numerical visual scale at 6 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.
Pain with movement24 hours after surgeryMeasured by the numerical visual scale at 48 hours after intradural anesthesia, minimum of 0 and maximum of 10, where means no pain and 10 means the worst pain in the life of the patient.

Secondary

MeasureTime frameDescription
Opioids dose6 hours after surgeryMeasured in milligrams of intravenous morphine hydrochloride daily.
Discharge daysDaysTime to discharge measured in days
Patient satisfaction24 hours after surgeryPatient satisfaction on a scale of 0 to 10, where 0 is minimum satisfaction and 10 is maximum satisfaction.
Ambulation timeUp to 24 hoursTime to ambulation (measured in hours) from discharge from URPA

Countries

Spain

Contacts

Primary ContactMadalina Dinu, Mrs
madidinu@hotmail.com0034600349517

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026