## Protocol Section
### Identification Module
**NCT ID:** NCT06431880

**Brief Title:** External Oblique Intercostal Plane Block Versus Thoracic Paravertebral Block for Post Thoracotomy Pain

**Official Title:** External Oblique Intercostal Plane Block Versus Thoracic Paravertebral Block for Post Thoracotomy Pain: A Randomized Non-inferiority Trial

#### Organization Study ID Info
**ID:** 36246PR638/4/24
#### Organization
**Class:** OTHER
**Full Name:** Tanta University
### Status Module
#### Completion Date
**Date:** 2024-12-01

**Type:** ESTIMATED

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

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

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

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Tanta University

#### Responsible Party

**Investigator Affiliation:** Tanta University

**Investigator Full Name:** Mohammed Said ElSharkawy

**Investigator Title:** Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The aim of this study is to compare the effectiveness of analgesia achieved by external oblique intercostal plane block (EOIPB)and thoracic paravertebral block (TPVB) for postoperative pain management in patients undergoing open thoracotomy.

**Detailed Description:** Acute thoracotomy pain is multifactorial in nature. It involves nociceptive and neuropathic mechanisms originating from somatic and visceral afferents. The main sources of pain are intercostal nerves, the vagus nerve and phrenic nerve in the pleura, the superficial cervical plexus, and the brachial plexus in the ipsilateral shoulder.

### Conditions Module

**Conditions:**

- External Oblique Intercostal Plane Block

- Thoracic Paravertebral Block

- Post Thoracotomy Pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 90

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients will receive external oblique intercostal plane block.

**Intervention Names:**

- Other: External oblique intercostal plane block

**Label:** External oblique intercostal plane block

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patients will receive thoracic paravertebral block.

**Intervention Names:**

- Other: Thoracic paravertebral block

**Label:** Thoracic paravertebral block

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- External oblique intercostal plane block

**Description:** Patients will receive external oblique intercostal plane block

**Name:** External oblique intercostal plane block

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Thoracic paravertebral block

**Description:** Patients will receive thoracic paravertebral block

**Name:** Thoracic paravertebral block

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Rescue analgesia of morphine will be given as 2 mg bolus if the numeric rating scale (NRS) \> 3 to be repeated after 30 min if pain persists until the numeric rating scale \< 4. numeric rating scale will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively.

**Measure:** Total morphine consumption

**Time Frame:** 24 hours postoperatively

#### Secondary Outcomes

**Description:** Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain).

**Measure:** Intraoperative fentanyl consumption

**Time Frame:** Intraoperative

**Description:** Mean arterial pressure will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.

**Measure:** Mean arterial pressure

**Time Frame:** Till the end of surgery

**Description:** Heart rate will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.

**Measure:** Heart rate

**Time Frame:** Till the end of surgery

**Description:** All patients will receive paracetamol 1 gm every 6 h as routine analgesia. Rescue analgesia of morphine will be given as 2 mg bolus if the numeric rating scale \> 3 to be repeated after 30 min if pain persists until the numeric rating scale \< 4. NRS will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively

**Measure:** Time to the 1st rescue analgesia

**Time Frame:** 24 hours postoperatively

**Description:** Degree of pain will be measured using numeric rating scale (NRS) (0 represents "no pain" while 10 represents "the worst pain imaginable").NRS will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively.

**Measure:** Degree of pain

**Time Frame:** 24 hours postoperatively

**Description:** Complications such as bradycardia, hypotension, nausea, vomiting, respiratory depression, local anesthetic systemic toxicity (LAST) or any other complication will be recorded.

**Measure:** Complications

**Time Frame:** 24 hour postoperatively

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-III.
* Scheduled for open thoracotomy

Exclusion Criteria:

* Patients with neurological or intellectual disability.
* Infection at the injection site.
* Opioid addiction.
* Allergic reaction to local anesthetics.
* Coagulation abnormalities.
* Drug abuse.
* Pregnancy.
* Severe liver and/or renal failure.
* Uncontrolled hypertension.
* Severe cardiovascular problems.
* Diabetes mellitus.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mselsharkawy@med.tanta.edu.eg

**Name:** Mohammed S Elsharkawy, MD

**Phone:** 00201148207870

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Tanta

**Contacts:**

***Contact 1:***

- **Email:** mselsharkawy@med.tanta.edu.eg

- **Name:** Mohammed S Elsharkawy, MD

- **Phone:** 00201148207870

- **Role:** CONTACT

***Contact 2:***

- **Name:** Saad A Moharam, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Ahmed E Abo ElKheir, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Egypt

**Facility:** Tanta University Hospitals

**State:** El-Gharbia Governorate, Egypt

**Zip:** 31527

### IPD Sharing Statement Module

**Access Criteria:** The data will be available upon a reasonable request from the corresponding author.

**Description:** The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

**Info Types:**

- STUDY_PROTOCOL

**IPD Sharing:** YES

**Time Frame:** After the end of study for one year.

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000094665

- Term: Dissection, Blood Vessel

- ID: D000000783

- Term: Aneurysm

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000094683

- Term: Acute Aortic Syndrome

- ID: D000001018

- Term: Aortic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M4114

- Name: Aortic Dissection

- Relevance: HIGH

- As Found: Thoracic

- ID: M3081

- Name: Dissection, Blood Vessel

- Relevance: LOW

- As Found: Unknown

- ID: M4113

- Name: Aneurysm

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M3085

- Name: Acute Aortic Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M4334

- Name: Aortic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000784

- Term: Aortic Dissection

### Misc Info Module

- Version Holder: 2024-05-31
