Comparison of Different Analgesic Nerve Blocks in Total Knee Replacement Surgery

NCT06422585 | Recruiting

• 1 other identifier: PGBLOCK
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Prosthesis; Pain, Procedural

Keywords

Knee; Post procedural pain; Regional anesthesia

Outcome Measures

Primary Outcomes (1)

• NRS

  To compare the analgesic effect at 24 hours, of a nerve block technique compared to others after selective spinal anesthetic is administerd to achieve surgical anesthesia.Evaluate pain for every group in the first 24 hours post surgery using the Numeric Pain Scale (NRS) assigning a numeric value between zero (no pain) and ten (the worst pain ever felt). Absence of relevant pain is considered a NRS less than three. Success of the block was defined as NRS≤3.

  Baseline, every 6 hours for the first 24 hours after surgery

Secondary Outcomes (1)

• side effect

  24 hours

Study Arms (3)

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.

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients meeting the inclusion criteria

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: lead

Study Sites (1)

Edificio 3 - Azienda Ospedaliero Universitaria Pisana Cisanello

Pisa, Tuscany, 56124, Italy

RECRUITING

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Silvia Nardi, MD

  Azienda Ospedaliera Universitaria Pisana

  STUDY DIRECTOR

• Alessandro Cardu, MD

  Scuola Specializzazione - Università di Pisa

  STUDY CHAIR

Central Study Contacts

Serena Ricalzone, MD

CONTACT

050.997881; serenaricalzone@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 21, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

IT (1)