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.

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis; Pain, Acute; Anesthesia
• Intervention / Treatment: Drug: IPACK block with Bupivacaine 0.25% with adrenaline

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Madalina Dinu, Mrs; Phone Number: 0034600349517; Email: madidinu@hotmail.com

Study Locations

• Spain
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Recruiting
      • Hospital Universitari Germans Trias i Pujol
      • Contact: Madalina Dinu; Phone Number: 0034600349517; Email: madidinu@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Echo-guided IPACK block; IPACK block using 0.25% bupivacaine 15mL with adrenaline once.	Drug: 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.; Other Names: Interspace between the Popliteal Artery and the Capsule of the posterior Knee
Active Comparator: Echo-guided sciatic block; Sciatic nerve block using 0.25% bupivacaine 15mL with adrenaline once.	Drug: 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.; Other Names: Interspace between the Popliteal Artery and the Capsule of the posterior Knee

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioids dose	Measured in milligrams of intravenous morphine hydrochloride daily.	6 hours after surgery
Opioids dose	Measured in milligrams of intravenous morphine hydrochloride daily.	24 hours after surgery
Opioids dose	Measured in milligrams of intravenous morphine hydrochloride daily.	48 hours after surgery
Discharge days	Time to discharge measured in days	Days
Patient satisfaction	Patient satisfaction on a scale of 0 to 10, where 0 is minimum satisfaction and 10 is maximum satisfaction.	24 hours after surgery
Ambulation time	Time to ambulation (measured in hours) from discharge from URPA	Up to 24 hours

Collaborators and Investigators

• Sponsor: Germans Trias i Pujol Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2020
• Primary Completion (Actual): June 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Total knee replacement; Block; Ipack
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Acute Pain; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Bupivacaine; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: IPACK-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No