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

NCT06514365 | Recruiting

• 1 other identifier: IPACK-20
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute; Knee Osteoarthritis; Anesthesia

Keywords

Ipack; Block; Total knee replacement

Outcome Measures

Primary Outcomes (9)

• Pain at rest

  Measured 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.

  6 hours after surgery

• Pain at rest

  Measured by the numerical visual scale at 24 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.

  24 hours after surgery

• Pain at rest

  Measured 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.

  48 hours after surgery

• Pain at movement

  Measured 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.

  6 hours after surgery

• Pain with movement

  Measured 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.

  24 hours after surgery

• Pain with movement

  Measured 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.

  48 hours after surgery

• Motor block

  Measured 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)).

  6 hours after surgery

• Motor block

  Measured 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)).

  24 hours after surgery

• Motor block

  Measured 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)).

  48 hours after surgery

Secondary Outcomes (6)

• Opioids dose

  6 hours after surgery

• Opioids dose

  24 hours after surgery

• Opioids dose

  48 hours after surgery

• Discharge days

  Days

• Patient satisfaction

  24 hours after surgery

Study Arms (2)

Echo-guided IPACK block

EXPERIMENTAL

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

Drug: IPACK block with Bupivacaine 0.25% with adrenaline

Echo-guided sciatic block

ACTIVE COMPARATOR

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

Drug: IPACK block with Bupivacaine 0.25% with adrenaline

Interventions

IPACK block with Bupivacaine 0.25% with adrenaline 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.

Also known as: Interspace between the Popliteal Artery and the Capsule of the posterior Knee

Echo-guided IPACK block; Echo-guided sciatic block

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead

Study Sites (1)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

MeSH Terms

Conditions

Acute Pain; Osteoarthritis, Knee; Bites and Stings

Interventions

Bupivacaine; Epinephrine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Madalina Dinu, Mrs

CONTACT

0034600349517; madidinu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 23, 2024
• Study Start: June 10, 2020
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)