## Protocol Section
### Identification Module
**NCT ID:** NCT06422585

**Brief Title:** Comparison of Different Analgesic Nerve Blocks in Total Knee Replacement Surgery

**Official Title:** Comparison of Three Different Analgesic Nerve Blocks in Total Knee Replacement Surgery

#### Organization Study ID Info
**ID:** PGBLOCK
#### Organization
**Class:** OTHER
**Full Name:** Azienda Ospedaliero, Universitaria Pisana
### Status Module
#### Completion Date
**Date:** 2025-02

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-19

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-02

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-02-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-26
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Azienda Ospedaliero, Universitaria Pisana

#### Responsible Party

**Investigator Affiliation:** Azienda Ospedaliero, Universitaria Pisana

**Investigator Full Name:** Serena Ricalzone

**Investigator Title:** principal investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Knee Prosthesis

- Pain, Procedural

**Keywords:**

- Knee

- Post procedural pain

- Regional anesthesia

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 180

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Label:** Femoral Nerve Block + IPACK Block

#### Arm Group 2

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

**Label:** Saphenous (Adductor Canal) Block + IPACK Block

#### Arm Group 3

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

**Label:** Dual Subsartorial Block

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** NRS

**Time Frame:** Baseline, every 6 hours for the first 24 hours after surgery

#### Secondary Outcomes

**Description:** Monitoring the onset of side effects (nausea/vomiting/hypotension/dizziness/sensitive impareiment) in every group of patients in the first 24 hours every six hours

**Measure:** side effect

**Time Frame:** 24 hours

### Eligibility Module

**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 Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** All patients meeting the inclusion criteria

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** serenaricalzone@gmail.com

**Name:** Serena Ricalzone, MD

**Phone:** 050.997881

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Pisa

**Contacts:**

***Contact 1:***

- **Name:** Serena Ricalzone, MD

- **Phone:** 050.997881

- **Role:** CONTACT

**Country:** Italy

**Facility:** Edificio 3 - Azienda Ospedaliero Universitaria Pisana Cisanello

**State:** Toscana

**Status:** RECRUITING

**Zip:** 56124

#### Overall Officials

**Official 1:**

**Affiliation:** Azienda Ospedaliera Universitaria Pisana

**Name:** Silvia Nardi, MD

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Scuola Specializzazione - Università di Pisa

**Name:** Alessandro Cardu, MD

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M1219

- Name: Pain, Procedural

- Relevance: HIGH

- As Found: Pain, Procedural

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000073818

- Term: Pain, Procedural

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Analg

- Name: Analgesics

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M1832

- Name: Levobupivacaine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
