## Protocol Section
### Identification Module
**NCT ID:** NCT06436105

**Brief Title:** COMPARISON OF PERIOPERATIVE ANALGESIC EFFECTIVENESS OF PATIENTS WHO HAD FASIA ILIAC COMPARTMENT BLOCK AND 4IN1 BLOCK APPLIED IN TOTAL KNEE PROSTHESIS SURGERY

**Official Title:** COMPARISON OF PERIOPERATIVE ANALGESIC EFFECTIVENESS OF PATIENTS WHO HAD FASIA ILIAC COMPARTMENT BLOCK AND 4IN1 BLOCK APPLIED IN TOTAL KNEE PROSTHESIS SURGERY

#### Organization Study ID Info
**ID:** İsa Öteleş
#### Organization
**Class:** OTHER_GOV
**Full Name:** Diskapi Yildirim Beyazit Education and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-08-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-07-25

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Diskapi Yildirim Beyazit Education and Research Hospital

#### Responsible Party

**Investigator Affiliation:** Diskapi Yildirim Beyazit Education and Research Hospital

**Investigator Full Name:** Savas Altinsoy

**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:** Patients who will undergo elective total knee arthroplasty surgery under spinal anesthesia will be included in the study according to the postoperative analgesia method applied: Group Control, Group FICB and Group 4in1. Peripheral nerve block will be performed with 30 ml %0.25 bupivacaine for Group FICB and Group 4 in 1 patients. Peripheral nerve block will not be performed on Group Control patients. Patient-controlled analgesia will be given to all three groups in the postoperative period. PCA is a pain palliation method routinely used in all patients postoperatively. NRS score, PCA tramadol consumption, PCA demand, need for additional analgesia, patient satisfaction, nausea and vomiting will be monitored 24 hours postoperatively. The aim of this study is to compare the perioperative analgesic effectiveness of patients who underwent fascia iliaca compartment block and 4 in 1 block in total knee arthroplasty surgery, with each other and with the control group.

**Detailed Description:** Total knee arthroplasty is a surgical procedure performed mostly on patients with osteoarthritis who have failed traditional conservative treatment. Increasing knee osteoarthritis due to reasons such as life expectancy and body mass index causes this surgical procedure to be performed more frequently. The knee joint which is innervated by the femoral, obturator, sciatic nerves and their branches has a complicated innervation and the pain following total knee arthrplasty is quite severe. It is aimed to provide effective analgesia by blocking these nerves or terminal branches with various peripheral nerve blockade methods under USG guidance. In recent years, interest in studies aiming to block these nerves with a single injection has been increasing. 4 in 1 block is a new technique applied from a single injection point to block the saphenous, obturator, sciatic and vastus medialis nerves that innervate the knee joint. Fascia iliaca compartment block is a reliable technique applied from a single injection point to block the femoral, lateral femoral cutaneous and obturator nerves behind the fascia iliaca.

Patients who will undergo elective total knee arthroplasty surgery under spinal anesthesia will be included in the study according to the postoperative analgesia method applied: Group Control, Group FICB and Group 4in1. Peripheral nerve block will be performed with 30 ml %0.25 bupivacaine for Group FICB and Group 4 in 1 patients. Peripheral nerve block will not be performed on Group Control patients. Patient-controlled analgesia will be given to all three groups in the postoperative period. PCA is a pain palliation method routinely used in all patients postoperatively. NRS score, PCA tramadol consumption, PCA demand, need for additional analgesia, patient satisfaction, nausea and vomiting will be monitored 24 hours postoperatively. The aim of this study is to compare the perioperative analgesic effectiveness of patients who underwent fascia iliaca compartment block and 4 in 1 block in total knee arthroplasty surgery, with each other and with the control group.

### Conditions Module

**Conditions:**

- Pain, Postoperative

**Keywords:**

- FICB

- 4 in 1 block

- Total knee arthroplasty

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Peripheral nerve block will not be performed on Group Control patients.

**Label:** Group Control

#### Arm Group 2

**Description:** FICB will be performed with 30 ml %0.25 bupivacaine for Group FICB patients.

**Intervention Names:**

- Other: FICB

**Label:** Group FICB

#### Arm Group 3

**Description:** 4 in 1 block will be performed with 30 ml %0.25 bupivacaine for Group 4 IN 1 patients.

**Intervention Names:**

- Other: 4 in 1 block

**Label:** Group 4 IN 1

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group FICB

**Description:** FICB is applied to the patients after spinal anesthesia.

**Name:** FICB

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Group 4 IN 1

**Description:** 4 in 1 block is applied to the patients after spinal anesthesia.

**Name:** 4 in 1 block

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Total tramadol consumption used in the first 24 hours postoperatively

**Measure:** Total tramadol consumption in 24 hours (mg)

**Time Frame:** 24 hours postoperatively

#### Secondary Outcomes

**Description:** NRS range was from 0-10 with being no pain and 10 the worst pain possible.

**Measure:** Pain on the Numeric Rating Scale (NRS)

**Time Frame:** 0 hours postoperatively

**Description:** NRS range was from 0-10 with being no pain and 10 the worst pain possible.

**Measure:** Pain on the Numeric Rating Scale (NRS)

**Time Frame:** 1 hours postoperatively

**Description:** NRS range was from 0-10 with being no pain and 10 the worst pain possible.

**Measure:** Pain on the Numeric Rating Scale (NRS)

**Time Frame:** 4 hours postoperatively

**Description:** NRS range was from 0-10 with being no pain and 10 the worst pain possible.

**Measure:** Pain on the Numeric Rating Scale (NRS)

**Time Frame:** 8 hours postoperatively

**Description:** NRS range was from 0-10 with being no pain and 10 the worst pain possible.

**Measure:** Pain on the Numeric Rating Scale (NRS)

**Time Frame:** 12 hours postoperatively

**Description:** NRS range was from 0-10 with being no pain and 10 the worst pain possible.

**Measure:** Pain on the Numeric Rating Scale (NRS)

**Time Frame:** 24 hours postoperatively

**Description:** Consumption of rescue analgesic used after 24 hours postoperatively.

**Measure:** Rescue Analgesic

**Time Frame:** 24 hours postoperatively

**Description:** The patient is satisfied or dissatisfied

**Measure:** Patient satisfaction

**Time Frame:** 24 hours postoperatively

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* With informed consent
* Elective total knee arthroplasty with spinal anesthesia
* Oriented and cooperative
* ASA Classification I-II-III
* 18-85 years old

Exclusion Criteria:

* Anticoagulant medication
* Coagulopathy
* Infection at the site of peripheral nerve block application
* Allergy to local anesthetics
* Pregnant or suspected pregnancy

**Maximum Age:** 85 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients who undergone total knee arthroplasty

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ankara

**Country:** Turkey

**Facility:** Department of Anesthesiology and Reanimation, University of Health Sciences, Diskapi Yıldırım Beyazit Training and Research Hospital

**Zip:** 06450

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Roy R, Agarwal G, Pradhan C, Kuanardr D, Mallick DJ. Ultrasound guided 4 in 1 block - a newer, single injection technique for complete postoperative analgesia for knee and below knee surgeries. Anaesthesia, Pain & Intensive Care. 2018;22(1):87-92.

**Citation:** Kanadli H, Dogru S, Karaman T, Karaman S, Tapar H, Sahin A, Asci M, Kanadli KA, Suren M. Comparison of the efficacy of femoral nerve block and fascia iliaca compartment block in patients with total knee replacement. Minerva Anestesiol. 2018 Oct;84(10):1134-1141. doi: 10.23736/S0375-9393.18.12062-1. Epub 2018 Jan 16.

**PMID:** 29338141

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

- 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: M13069

- Name: Pain, Postoperative

- Relevance: HIGH

- As Found: Pain, Postoperative

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010149

- Term: Pain, Postoperative

### 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: M5315

- Name: Bupivacaine

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
