## Protocol Section
### Identification Module
**NCT ID:** NCT05661279

**Brief Title:** Rhomboid Intercostal Block Versus Serratus Anterior Plane Block

**Official Title:** Ultrasound Guided Rhomboid Intercostal Block Versus Serratus Anterior Plane Block for Analgesia After Thoracodorsal Artery Perforator Flap Following Partial Mastectomy

#### Organization Study ID Info
**ID:** zu-IRB # 10060
#### Organization
**Class:** OTHER_GOV
**Full Name:** Zagazig University
### Status Module
#### Completion Date
**Date:** 2023-10-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-09-06

**Type:** ACTUAL

**Last Update Submit Date:** 2023-09-02

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2023-10-02

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-12-30

**Type:** ACTUAL

**Status Verified Date:** 2023-09

#### Study First Post Date
**Date:** 2022-12-22
**Type:** ACTUAL
**Study First Submit Date:** 2022-12-01
**Study First Submit QC Date:** 2022-12-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Zagazig University

#### Responsible Party

**Investigator Affiliation:** Zagazig University

**Investigator Full Name:** Heba M Fathi

**Investigator Title:** prof/Dr

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** evaluate and compare the impact of ultrasound guided rhomboid intercostal block versus serratus anterior plane block for analgesia after thoracodorsal artery perforator flap following partial mastectomy

**Detailed Description:** * To assess and compare quality of post- operative analgesia in each group.
* Time of performance of block in both groups.
* To assess and compare post-operative hemodynamics as well as anticipated adverse effects including nausea, vomiting, itching, hemorrhage, bradycardia, hypotension.

### Conditions Module

**Conditions:**

- Postoperative Pain

**Keywords:**

- rhomboid intercostal block -serratus anterior plane block - thoracodorsal artery perforator flap

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 84

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** control group who will be given general anesthesia only

**Intervention Names:**

- Procedure: general anesthesia

**Label:** Group C:

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Rhomboid intercostal block then general anesthesia

**Intervention Names:**

- Procedure: general anesthesia

- Procedure: general anesthesia plus Rhomboid intercostal block

**Label:** Group R:

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** Serratus anterior plane block then general anesthesia

**Intervention Names:**

- Procedure: general anesthesia

- Procedure: Serratus anterior plane block

**Label:** group S

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group C:

- Group R:

- group S

**Description:** general anesthesia

**Name:** general anesthesia

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Group R:

**Description:** the patients will be positioned in lateral decubitus with moving the scapula laterally by abducting the ipsilateral arm across the chest. under complete aseptic situations A high-frequency (6-12 MHz) linear US probe will be put medial to the medial border of the scapula in an oblique sagittal plane with the orientation marker directed cranially.at the T6-7 level, the tissue plain between the rhomboid major and intercostal muscles is identified, and a single injection of 25mL of bupivacaine (0.25%) will be administered via 18-gauge Tuohy advanced in plane from a superomedial to an inferolateral direction, followed by general anesthesia

**Name:** general anesthesia plus Rhomboid intercostal block

**Type:** PROCEDURE

#### Intervention 3

**Arm Group Labels:**

- group S

**Description:** The patient will be positioned supine with his arm abducts at 90°. the US high frequency (6-12 MHz) linear probe of sonosite M turbo ultrasonography (FUJIFIM sonosite, Inc., Bothell, WA, USA) will be put in sagittal plane at the midaxillary line. identification of the fascial plane between the serratus anterior muscle and external intercostal muscles will be performed between the fourth and fifth ribs in the midaxillary area . At this point the18-gauge Tuohy needle will be advanced in plane with injection of 25mL of 0.25 %, bupivacaine. followed by general anesthesia

**Name:** Serratus anterior plane block

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** The amount of tramadol consumption

**Measure:** tramadol consumption

**Time Frame:** at 24 hours postoperative

#### Secondary Outcomes

**Description:** Time needed to performance the block

**Measure:** Time of performance of block

**Time Frame:** time from positioning of ultrasound porbe till the end of block procedure.

**Description:** the first time that the patients need analgesia when VAS ≥ 3

**Measure:** Time to first dose of rescue analgesia

**Time Frame:** during the first 24 hours postoperatively

**Description:** nausea, vomiting, local anesthesia toxicity, needle injury

**Measure:** Anticipated side effect

**Time Frame:** at 24 hous post operative

**Description:** Post operative patient's satisfaction using 3 point scale (1= satisfied ,2=neutral, 3=not satisfied)

**Measure:** Post operative patient's satisfaction

**Time Frame:** at 24 hours post operative

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adult patients aged between 21 to 60 years
* Undergoing pedicled thoracodorsal artery perforator flap following breast conserving surgery -General anesthesia
* Informed consents
* ASA I \& II
* Body mass index 25-30 kg/m2.

Exclusion Criteria:

* patients on anti-platelet, anticoagulant or B blocker drugs
* Patients with acute decompensated heart failure, hypertension, heart block, coronary disease, Asthma, bleeding disorders, compromised renal or hepatic function
* history of allergy to local anesthesia or opioid analgesia,
* pregnancy.

**Healthy Volunteers:** True

**Maximum Age:** 60 Years

**Minimum Age:** 21 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** heba_elgendi@yahoo.com

**Name:** Heba M Fathi, M.D

**Phone:** 01000143938

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Zagazig

**Contacts:**

***Contact 1:***

- **Email:** heba_elgendi@yahoo.com

- **Name:** Heba M Fathi, M.D

- **Role:** CONTACT

**Country:** Egypt

**Facility:** Heba M Fathi

**Status:** RECRUITING

**Zip:** 44519

#### Overall Officials

**Official 1:**

**Affiliation:** faculty of human medicine ,zagazig university

**Name:** Heba M Fathi

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## 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: Postoperative Pain

- 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 - Ancestors

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: HIGH

- As Found: Imaging

- ID: M5315

- Name: Bupivacaine

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000777

- Term: Anesthetics

### Misc Info Module

- Version Holder: 2024-05-24
