## Protocol Section
### Identification Module
**NCT ID:** NCT06436599

**Brief Title:** Comparison of Analgesic Efficacy of Serratus Anterior Plan Block and Serratus Posterior Superior Intercostal Plan Block in Breast Surgery

**Official Title:** Comparison of Analgesic Efficacy of Serratus Anterior Plan Block and Serratus Posterior Superior Intercostal Plan Block in Breast Surgery

#### Organization Study ID Info
**ID:** Medeniyet University
#### Organization
**Class:** OTHER
**Full Name:** Istanbul Medeniyet University
### Status Module
#### Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-28

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-12-13

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Mustafa Burgac

#### Responsible Party

**Investigator Affiliation:** Istanbul Medeniyet University

**Investigator Full Name:** Mustafa Burgac

**Investigator Title:** principal investigator

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The application of regional anaesthetic procedures in breast surgery is associated with a lower incidence of chronic pain, reduced morbidity, shorter hospital stay and less opioid requirement. Therefore, we aimed to evaluate the postoperative analgesic efficacy of Serratus Anterior Plan Block and Serratus Posterior Superior Intercostal Plan Block in breast surgery.

**Detailed Description:** Breast conserving surgery is one of the most common operations performed by General Surgery and may be associated with acute postoperative pain. Acute postoperative pain is an independent risk factor for the development of chronic pain after mastectomy. Various regional anaesthetic procedures have been tried to achieve better acute pain control and thus less chronic pain. The use of regional anaesthetic procedures in breast surgery is associated with a lower incidence of chronic pain, reduced morbidity, shorter hospital stay and less opioid requirement.

Interfascial plane blocks have become popular because they are easy to perform and safe. Since interfascial plan blocks are based on the injection of local anaesthetic between two fasciae, the complication rate such as nerve damage is very low. With this method, effective analgesia can be provided in various areas such as abdominal, thoracic and lumbar regions while reducing opioid consumption and avoiding neuraxial methods.

In randomised controlled trials investigating the efficacy of Serratus Anterior Plane Block for postoperative analgesia management after breast surgery, adequate analgesia was reported.

Serratus posterior superior intercostal plan block, a newly defined interfascial plan block, has been shown to provide a wide sensory blockade between intercostal muscles. Postoperative analgesic efficacy has been demonstrated in thoracic, breast and shoulder surgeries.

The aim of our study was to evaluate the postoperative analgesic efficacy of Serratus Anterior Plan Block and Serratus Posterior Superior Intercostal Plan Block in breast surgery.

### Conditions Module

**Conditions:**

- Analgesia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Serratus posterior superior intercostal plane block was applied to a certain group of patients for postoperative anaesthesia.

**Intervention Names:**

- Drug: plane block with %0.25 30 ml bupivacaine

**Label:** Patients with serratus posterior superior intercostal plan block

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Serratus anterior plane block was applied to a certain group of patients for postoperative anaesthesia.

**Intervention Names:**

- Drug: plane block with %0.25 30 ml bupivacaine

**Label:** Patients with serratus anterior plan block

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Patients with serratus anterior plan block

- Patients with serratus posterior superior intercostal plan block

**Description:** evaluation of the efficacy of two different plan blocks for postoperative anaesthesia

**Name:** plane block with %0.25 30 ml bupivacaine

**Other Names:**

- postoperative anaesthesia

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Evaluation of which of the two plan blocks is more effective in postoperative anaesthesia.

Postoperative pain scores will be evaluated with a numerical pain score. Evaluation will be performed postoperatively at 30. minutes, 1. hour, 4. hours, 8. hours, 12. hours and 24. hours.

**Measure:** evaluation of anelgesic efficacy of postoperative plan blocks with numerical pain score

**Time Frame:** postoperative 24 hours

#### Secondary Outcomes

**Description:** Before the end of the surgical procedure, the patient will be administered 1 mg/kg tramadol and 1 g paracetamol.

Intra venous tramadol will be administered with a pain pump for pain control for 24 hours postoperatively.

The amount of tramadol used in both plane blocks will be compared.

**Measure:** postoperative used anelgesic quantity

**Time Frame:** postoperative 24 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* unilateral mastectomy
* ASA I-III risk group

Exclusion Criteria:

* Coagulopathy
* Wound and infection in the block area
* Local anaesthetic allergy
* Mental retardation
* Non-cooperative
* Pregnant patients

**Healthy Volunteers:** True

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mustafaburgac@gmail.com

**Name:** Mustafa Burgaç

**Phone:** 05389848198

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** İstanbul

**Contacts:**

***Contact 1:***

- **Email:** mustafaburgac@gmail.com

- **Name:** Mustafa Burgaç

- **Phone:** +905389848198

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Istanbul Professor Doctor Süleyman Yalçın City Hospital

**Status:** RECRUITING

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000000779

- Term: Anesthetics, Local

- ID: D000000777

- Term: Anesthetics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

### 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: HIGH

- As Found: Following

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000002045

- Term: Bupivacaine

### Misc Info Module

- Version Holder: 2024-05-31
