## Protocol Section
### Identification Module
**NCT ID:** NCT06423677

**Brief Title:** Analgesic Efficacy of Serratus Posterior Superior Intercostal Plane (SPSIP) Block in Shoulder Arthroscopies

**Official Title:** Evaluation of the Analgesic Efficacy of Serratus Posterior Superior Intercostal Plane (SPSIP) Block in Shoulder Arthroscopies: A Randomized Controlled Prospective Multicenter Study

#### Organization Study ID Info
**ID:** Serratus Posterior Superior
#### Organization
**Class:** OTHER
**Full Name:** Kanuni Sultan Suleyman Training and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-27

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-25

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Kanuni Sultan Suleyman Training and Research Hospital

#### Responsible Party

**Investigator Affiliation:** Kanuni Sultan Suleyman Training and Research Hospital

**Investigator Full Name:** Engin Ihsan Turan

**Investigator Title:** Specialist

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Patients in the block group will be placed in a lateral position with the operated shoulder on top before awakening from surgery. After ensuring aseptic conditions (the block site will be wiped three times with 10% povidone-iodine), the linear ultrasound probe will be covered in a sterile manner. While performing the block, the Hitachi brand linear ultrasound probe will be placed parallel to the scapular spine on the surgical side and will be slid medially. After imaging the 2nd and 3rd ribs on the medial side of the scapular spine, the block needle will be advanced under ultrasound guidance onto the 3rd rib. After contacting the rib with the needle, it will be retracted by 1mm, and the block site will be confirmed by injecting sterile 0.9% NaCl. Subsequently, patients will be administered 30ml of 0.25% bupivacaine in a controlled manner.

Before awakening, both the block group and the non-block group will be administered 1g of paracetamol and 1mg/kg of tramadol intravenously. In the postoperative period, these patients will be provided with multimodal analgesia, including intravenous patient-controlled analgesia (PCA) with 4mg/ml Tramadol HCl in 100ml NaCl. There will be no basal infusion, with bolus doses of 20mg and a lockout period of 20 minutes, and a total dose limitation of 200mg over 4 hours. Patients will be visited at 0, 1, 6, 12, and 24 hours, and they will be asked to draw their visual analog scale (VAS) score on a paper scale. The amount of opioid used in the PCA and the need for rescue analgesia (Arveles 50mg intravenously) will be assessed. Patients will routinely receive 4x1g paracetamol in the postoperative period.

### Conditions Module

**Conditions:**

- Pain, Postoperative

- Shoulder Pain

- Block

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 52

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** serratus posterior superior intercostal plane block will be administered to these group. after the extubation intravenous patient controlled analgesia (PCA) will also be administered to patients.

**Intervention Names:**

- Procedure: Serratus Posterior Superior Intercostal Plane Block

- Device: patient controlled analgesia

**Label:** serratus posterior superior intercostal plane block + intravenous patient controlled analgesia

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** After the extubation, only intravenous patient controlled analgesia (PCA) will be administered to patients.

**Intervention Names:**

- Device: patient controlled analgesia

**Label:** intravenous patient controlled analgesia

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- serratus posterior superior intercostal plane block + intravenous patient controlled analgesia

**Description:** The Serratus Posterior Superior Intercostal Plane Block will be performed under ultrasound guidance. During the block, a linear ultrasound probe will be placed parallel to the spine of the scapula on the surgical side and then slid medially. The block needle will be advanced under ultrasound guidance over the 3rd rib. After the needle touches the rib, it will be withdrawn by 1mm, and the block site will be confirmed by injecting sterile 0.9% NaCl. Subsequently, patients will be administered 50mg of bupivacaine and 100mg of lidocaine in a controlled manner.

**Name:** Serratus Posterior Superior Intercostal Plane Block

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- intravenous patient controlled analgesia

- serratus posterior superior intercostal plane block + intravenous patient controlled analgesia

**Description:** intravenous patient-controlled analgesia (PCA) with 4mg/ml Tramadol HCl in 100ml NaCl. There will be no basal infusion, with bolus doses of 20mg and a lockout period of 20 minutes, and a total dose limitation of 200mg over 4 hours

**Name:** patient controlled analgesia

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Patients will be visited at 0, 1, 6, 12, and 24 hours, and they will be asked to draw their visual analog scale (VAS) score on a paper scale.0 means no pain, 10 means the most intense pain. 4 or more Visual analog scale scores means patients need rescue analgesia.

**Measure:** visual analog scale score

**Time Frame:** 0, 1, 6, 12, and 24 hours

**Description:** Patients will be visited at 0, 1, 6, 12, and 24 hours and opioid consumption in the patient controlled analgesia device will be noted.0 means no pain, 10 means the most intense pain. 4 or more Visual analog scale scores means patients need rescue analgesia.

**Measure:** opioid consumption

**Time Frame:** 0, 1, 6, 12, and 24 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Obtaining consent from the patient and their relative
* ASA score of I-II
* No bleeding diathesis
* No history of anticoagulant use
* No history of neuropathic diseases such as Diabetes Mellitus
* Patients aged 18-65 years undergoing shoulder arthroscopy surgery

Exclusion Criteria:

* Lack of consent from the patient or their relative
* Patients with an ASA score of III or above
* Patients with a history of bleeding diathesis
* Conditions where regional anesthesia is contraindicated
* Patients with a history of neuropathic diseases
* Patients under 18 years or over 65 years of age
* Patients with a history of allergies to the aforementioned medications
* Patients with an infection at the site where the block will be administered

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** enginihsan@hotmail.com

**Name:** Engin ihsan Turan

**Phone:** +9005382431114

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Istanbul

**Country:** Turkey

**Facility:** Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

**Zip:** 34303

#### Overall Officials

**Official 1:**

**Affiliation:** Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

**Name:** Engin ihsan Turan

**Role:** PRINCIPAL_INVESTIGATOR

## 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

- ID: D000018771

- Term: Arthralgia

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- 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: M21907

- Name: Shoulder Pain

- Relevance: HIGH

- As Found: Shoulder Pain

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M20833

- Name: Arthralgia

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000020069

- Term: Shoulder Pain

- 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: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: ChanBlk

- Name: Channel Blockers

- Abbrev: Analg

- Name: Analgesics

### Intervention Browse Module - Browse Leaves

- ID: M5315

- Name: Bupivacaine

- Relevance: LOW

- As Found: Unknown

- ID: M11014

- Name: Lidocaine

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M16901

- Name: Tramadol

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
