## Protocol Section
### Identification Module
**NCT ID:** NCT06419504

**Brief Title:** The Effect of Ultrasonography-guided Fascial Plane Blocks in Breast Cancer Surgery Patients

**Official Title:** The Effect of Ultrasonography-guided Pectoserratus Plane Block, Erector Spina Plane Block and Serratus Anterior Plane Block on Postoperative Opioid Consumption, Recovery Quality and Chronic Pain in Breast Cancer Surgery Patients

#### Organization Study ID Info
**ID:** 6/11
#### Organization
**Class:** OTHER_GOV
**Full Name:** Antalya Training and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-11-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-10-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Antalya Training and Research Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The aim of this study was to evaluate the efficacy of serratus anterior plane (SAP) block, pectoserratus plane (PECS II) block, and erector spinae plane (ESP) block on postoperative acute pain, quality of recovery and chronic pain in breast cancer surgery patients.

**Detailed Description:** Breast cancer is the most common type of cancer in women. Although surgical treatment is effective and curative, it is associated with many complications in the postoperative period. Acute pain after surgery is one of them. Approximately half of women undergoing breast surgery describe significant post-operative pain (\>5 on the Visual Analogue Scale; VAS) score that is not always effectively controlled by standard post-operative treatments. Poorly controlled postoperative pain has been associated with impaired functional recovery, delayed discharge from the post-anesthetic care unit, and prolonged hospital stay. In addition, poorly managed acute pain becomes chronic and is described as 'post-mastectomy pain syndrome'. Regional techniques can reduce acute and chronic postoperative pain. The development of ultrasonography (US)-guided regional anesthesia has led to the development of fascial plane blocks. Serratus anterior plan (SAP) block, pectoserratus plan (PECS II) block, and erector spina plan (ESP) block are frequently used for postoperative analgesia in patients undergoing breast surgery. he aim of this study was to evaluate the efficacy of serratus anterior plane (SAP) block, pectoserratus plane (PECS II) block, and erector spinae plane (ESP) block on postoperative acute pain, quality of recovery and chronic pain in breast cancer surgery patients.

### Conditions Module

**Conditions:**

- Breast Cancer

**Keywords:**

- regional anesthesia

- postoperative pain

- recovery quality

- chronic pain

- breast cancer

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 96

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Before the surgery, US-guided SAP block will be performed

**Intervention Names:**

- Other: SAP block group

**Label:** SAP block group

#### Arm Group 2

**Description:** Before the surgery, US-guided PECS II block will be performed

**Intervention Names:**

- Other: PECS II block group

**Label:** PECS II block group

#### Arm Group 3

**Description:** Before the surgery, US-guided ESP blockwill be performed

**Intervention Names:**

- Other: ESP block group

**Label:** ESP block group

#### Arm Group 4

**Description:** No intervention

**Intervention Names:**

- Other: Control group

**Label:** Control group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- SAP block group

**Description:** US-guided SAP block is performed approximately 30 minutes before the surgery in patients undergoing breast cancer surgery in a separate regional anesthesia room with standard anesthesia monitoring.

**Name:** SAP block group

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- PECS II block group

**Description:** US-guided PECS II block is performed approximately 30 minutes before the surgery in patients undergoing breast cancer surgery in a separate regional anesthesia room with standard anesthesia monitoring.

**Name:** PECS II block group

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- ESP block group

**Description:** US-guided ESP block is performed approximately 30 minutes before the surgery in patients undergoing breast cancer surgery in a separate regional anesthesia room with standard anesthesia monitoring.

**Name:** ESP block group

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- Control group

**Description:** No intervention

**Name:** Control group

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** All patients will receive a standard patient controlled analgesia (PCA) protocol. The postoperative opioid consumption will only be recorded.

**Measure:** postoperative opioid consumption

**Time Frame:** 24 hours

#### Secondary Outcomes

**Description:** The Quality of Recovery-15 (QoR-15) is a 15-question questionnaire validated to assess poetoperative recovery. This questionnaire assesses patients' pain, physical comfort, physical independence, psychological support, and emotional status in the erly postoperative period. The patient is asked to express their status scoring from 0 to 10; therefore, the total score ranges from 0 to 150 points.

**Measure:** recovery quality

**Time Frame:** 5 minutes

**Description:** Patients will be telephoned 3 months after the operation and the presence, localization, and intensity of the pain, its character, and its relation with rest and/or activity will be recorded by asking only verbally.

**Measure:** chronic pain

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* elective breast surgery (modified radical mastectomy, breast conserving surgery, simple mastectomy, axillary lymph node dissection, etc.),
* 18 to 65 years old,
* American Society of Anaesthesiology (ASA) score I-III
* body mass index (BMI) \<32 kg/m2

Exclusion Criteria:

* contraindications to the block applications
* history of mental or neurological disorders
* history of chronic opioid use
* chronic alcoholism
* substance use
* treatment of chronic pain
* severe liver and kidney disease
* uncooperative patients
* patients scheduled for bilateral mastectomy

**Gender Based:** True

**Gender Description:** The patients scheduled for elective breast surgery (modified radical mastectomy, breast conserving surgery, simple mastectomy, axillary lymph node dissection, etc.)

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** It is planned to include ASA I-III patients between the ages of 18-65 who are planned to undergo breast cancer surgery

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** arzukaraveli@sbu.edu.tr

**Name:** Arzu Karaveli, M.D.

**Phone:** +905325611300

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Antalya

**Contacts:**

***Contact 1:***

- **Name:** Antalya Training and Research Hospital

- **Role:** CONTACT

**Country:** Turkey

**Facility:** University of Health Sciences, Antalya Training and Researh Hospital

**State:** Muratpaşa

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** University of Health Sciences, Antalya Training and Researh Hospital

**Name:** Hafizenur O Atalay, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** University of Health Sciences, Antalya Training and Researh Hospital

**Name:** Arzu O Karaveli, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Wang S, Shi J, Dai Y, Zhang J, Liu Q, Yang P, Zhu N. The effect of different nerve block strategies on the quality of post-operative recovery in breast cancer patients: A randomized controlled study. Eur J Pain. 2024 Jan;28(1):166-173. doi: 10.1002/ejp.2178. Epub 2023 Sep 1.

**PMID:** 37655864

**Citation:** Fujii T, Shibata Y, Akane A, Aoki W, Sekiguchi A, Takahashi K, Matsui S, Nishiwaki K. A randomised controlled trial of pectoral nerve-2 (PECS 2) block vs. serratus plane block for chronic pain after mastectomy. Anaesthesia. 2019 Dec;74(12):1558-1562. doi: 10.1111/anae.14856. Epub 2019 Sep 19.

**PMID:** 31535722

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13069

- Name: Pain, Postoperative

- Relevance: LOW

- As Found: Unknown

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M29442

- Name: Chronic Pain

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M29453

- Name: Mastodynia

- Relevance: LOW

- As Found: Unknown

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

### 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: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
