## Protocol Section
### Identification Module
**NCT ID:** NCT06426706

**Brief Title:** TPVB or SPSIPB in Pain Management After VATS

**Official Title:** Paravertebral Block or Serratus Posterior Superior Intercostal Plane Block in Pain Management After Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Clinical Trial

#### Organization Study ID Info
**ID:** 2024.174.IRB1.019
#### Organization
**Class:** OTHER
**Full Name:** Koç University
### Status Module
#### Completion Date
**Date:** 2024-09-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-19

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Koç University

#### Responsible Party

**Investigator Affiliation:** Koç University

**Investigator Full Name:** Kamil Darcin

**Investigator Title:** MD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The goal of this clinical trial is to compare the analgesic efficacy of thoracal paravertebral block (TPVB) and serratus posterior superior intercostal plane block (SPSIPB) in patients undergoing video-assisted thoracoscopic surgery (VATS). The main questions it aims to answer are:

How will the total perioperative opioid consumption of the patients receiving two different blocks change? How will TPVB and SPSIPB effect the patients' numeric rating scores for pain in the postoperative 24-hour period? How will TPVB and SPSIPB effect the incidence of opioid related side effects?

Participants will be divided in two groups:

TPVB group will receive a TPVB before the surgery. SPSIPB group will receive a SPSIPB nerve block before the surgery. Researchers will compare the results between the groups to see the postoperative effects concerning opioid consumption as well as the pain scores, respiratory parameters and opioid associated side effects.

The hypothesis of this study is that participants receiving SPSIPB for VATS will have a less total opioid consumption 24 hours postoperatively.

**Detailed Description:** Video-assisted thoracoscopic surgeries require a surgical incision of the lateral thoracic wall. In order to ease the postoperative pain of patients undergoing VATS, some regional anaesthesia techniques have been tried but there is no consensus on the best method. The gold standard peripheric nerve block is considered to be thoracal paravertebral block (TPVB). Recently, a new nerve block called serratus posterior superior intercostal plane block (SPSIPB) has been described. The anatomic and radiologic studies of SPSIPB suggest that the local anaesthetic distributes from C7 to T10 vertebrates, covering the surgical site of VATS. This study aims to compare the analgesic efficacy of TPVB and SPSIPB for VATS. The hypothesis is that participants receiving SPSIPB for VATS will have a less total opioid consumption 24 hours postoperatively. Also, the postoperative pain scores and opioid related side effects of the participants will be recorded. Participants will be divided in two groups. The group P will receive a TPVB preoperatively in the operating room. The group S will receive a SPSIPB preoperatively in the operating room. The participants will be followed 24 hours postoperatively and their total opioid consumption, numeric rating scores for pain, incidence of opioid related side effects will be recorded. Also the participants and the surgical teams perioperative pain related satisfaction will be evaluated.

### Conditions Module

**Conditions:**

- Video-assisted Thoracoscopic Surgery

- Paravertebral Block

- Serratus Posterior Superior Intercostal Plane Block

- Regional Anesthesia Morbidity

**Keywords:**

- video-assisted thoracoscopic surgery

- paravertebral block

- serratus posterior superior intercostal plane block

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 44

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants who will be receiving a serratus posterior superior intercostal plane block

**Intervention Names:**

- Procedure: Serratus Posterior Superior Intercostal Plane Block

**Label:** Group S

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants who will be receiving a thoracal paravertebral block

**Intervention Names:**

- Procedure: Paravertebral Block

**Label:** Group P

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group S

**Description:** Before the induction of general anesthesia, under aseptic conditions, serratus posterior superior intercostal plane block will be performed with a single dose of 30 ml of %0,25 bupivacaine with ultrasound guidance, by the senior anaesthesiologist.

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

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Group P

**Description:** Before the induction of general anesthesia, under aseptic conditions, paravertebral block will be performed with a single dose of 30 ml of %0,25 bupivacaine with ultrasound guidance, by the senior anaesthesiologist.

**Name:** Paravertebral Block

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** all consumed opioids will be converted in morphine equivalents and then added to reach the total dosage

**Measure:** Total opioid consumption

**Time Frame:** 24 hours post-surgery

#### Secondary Outcomes

**Description:** the scale between 0: no pain and 10:highes pain answered by the participants

**Measure:** Numeric rating scale scores for pain

**Time Frame:** 24 hours post-surgery

**Description:** Nausea, vomiting, pruritis, respiratory depression assessed by yes/no questions

**Measure:** Opioid related side effects

**Time Frame:** 24 hours post-surgery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients between the age of 18-80 undergoing video-assisted thoracoscopic surgery

Exclusion Criteria:

* Allergy to local anaesthetics Chronic opioid use history Patients with psychiatric disorders Patients who are not open to communication Patients with chronic organ failure Patients that do not give consent Patients that need emergency surgery within the first 24 hours of the initial surgery

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** drdarcink@gmail.com

**Name:** Kamil Darçın, MD

**Phone:** +90 505 589 50 99

**Role:** CONTACT

**Contact 2:**

**Email:** sincer.yasemin@gmail.com

**Name:** Yasemin Sincer, MD

**Phone:** +90 531 204 08 34

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** İstanbul

**Contacts:**

***Contact 1:***

- **Email:** kdarcin@ku.edu.tr

- **Name:** Kamil Darçın

- **Phone:** +905055895099

- **Role:** CONTACT

***Contact 2:***

- **Email:** sincer.yasemin@gmail.com

- **Name:** Yasemin Sincer

- **Phone:** +90512040834

- **Role:** CONTACT

***Contact 3:***

- **Name:** Kamil Darçın

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Turkey

**Facility:** Koc University

**Status:** RECRUITING

**Zip:** 34010

#### Overall Officials

**Official 1:**

**Affiliation:** Koç University

**Name:** Kamil Darçın, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** no access criteria

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

- ANALYTIC_CODE

**IPD Sharing:** YES

**Time Frame:** Starting from 6 months after publication for 5 years

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

### 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: M5315

- Name: Bupivacaine

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
