Comparison of Different Analgesic Nerve Blocks in Total Knee Replacement Surgery

NCT ID: NCT06422585

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-02-28

Brief Summary

The goal of this observational study is to compare the equivalent analgesic efficacy of three regional anesthesia techniques in total knee replacement surgery. The main question it aims to answer is:

• Non inferiority of each technique in relation to the others Participants will receive selective spinal anesthesia and the antalgic nerve block depending on the group they happen to be in.

Researchers will compare the Femoral Nerve Group+IPACK block, the Saphenous Nerve block+IPACK and the Subsartorial Block groups to see if there is any difference in the pain control in the 24 hours after the surgery.

Detailed Description

After adequate venous access is obtained, a light sedation with Midazolam 1-2 mg is administered. The patient will be monitored and a selective spinal anesthesia will be performed. After the neuraxial procedure the antalgic block of choice is performed with about 40 mL of long acting local anesthetic.

Magnesium Solfate 1g and Dexametasone 4mg are administered after the block. If the patient wishes, a propofol continuos infusion may be administered for sedation during the surgery. Before the patient leaves the OR, Ketorolac 30mg will be administered.

Pain control after surgery will be achieved with acetaminophen 1g t.i.d., Ketorolac 30mg on demand, and Morphine solfate if NRS >5 after Ketorolac.

Every 6 hours the patient will be monitored by the anesthesia team. After 24 hours the antalgic effect of the nerve block is reasonably thought to be over, so the follow up is interrupted.

Conditions

Knee Prosthesis; Pain, Procedural

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Femoral Nerve Block + IPACK Block

After adequate venous access has been obtained, spinal anesthesia with Levobupivacaine will be performed. After which antalgic Femoral Nerve Block and IPACK Block will be performed.

No interventions assigned to this group

Saphenous (Adductor Canal) Block + IPACK Block

After adequate venous access has been obtained, spinal anesthesia with Levobupivacaine will be performed. After which Saphenous and IPACK Block will be performed.

No interventions assigned to this group

Dual Subsartorial Block

After adequate venous access has been obtained, spinal anesthesia with Levobupivacaine will be performed. After which Dual Subsartorial Block will be performed.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age > 18 y/o
• Total knee replacement elective surgery
• Informed consent

Exclusion Criteria

• Age < 18 y/o
• Surgery with general anesthesia
• Patients with coagulopaties
• Patients in chronic opioid therapy
• Refuse to sign informed consent form
• Unable to sign informed consent form
• Know allergies to medication used for analgesia

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero, Universitaria Pisana

OTHER

Sponsor Role: lead

Responsible Party

Serena Ricalzone

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silvia Nardi, MD

Role: STUDY_DIRECTOR

Azienda Ospedaliera Universitaria Pisana

Alessandro Cardu, MD

Role: STUDY_CHAIR

Scuola Specializzazione - Università di Pisa

Locations

Edificio 3 - Azienda Ospedaliero Universitaria Pisana Cisanello

Pisa, Tuscany, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Serena Ricalzone, MD

Role: CONTACT

serenaricalzone@gmail.com

050.997881

Facility Contacts

Serena Ricalzone, MD

Role: primary

050.997881

Other Identifiers

PGBLOCK

Identifier Type: -

Identifier Source: org_study_id