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

NCT ID: NCT06514365

Last Updated: 2024-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-10

Study Completion Date

2024-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pain, Acute Knee Osteoarthritis Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Echo-guided IPACK block

IPACK block using 0.25% bupivacaine 15mL with adrenaline once.

Group Type EXPERIMENTAL

IPACK block with Bupivacaine 0.25% with adrenaline

Intervention Type DRUG

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.

Echo-guided sciatic block

Sciatic nerve block using 0.25% bupivacaine 15mL with adrenaline once.

Group Type ACTIVE_COMPARATOR

IPACK block with Bupivacaine 0.25% with adrenaline

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Interspace between the Popliteal Artery and the Capsule of the posterior Knee

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Germans Trias i Pujol Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dinu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Madalina Dinu, Mrs

Role: CONTACT

0034600349517

Facility Contacts

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Madalina Dinu

Role: primary

0034600349517

Other Identifiers

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IPACK-20

Identifier Type: -

Identifier Source: org_study_id

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