## Protocol Section
### Identification Module
**NCT ID:** NCT06422182

**Brief Title:** Erector Spinae Plane Block in Radical Cystectomy

**Official Title:** Ultrasound-Guided Erector Spinae Plane Block in Radical Cystectomy: A Randomized Controlled Study

#### Organization Study ID Info
**ID:** 2112-301-058
#### Organization
**Class:** OTHER
**Full Name:** Kafrelsheikh University
### Status Module
#### Completion Date
**Date:** 2024-01-15

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

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

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-01-15

**Type:** ACTUAL

#### Start Date
**Date:** 2021-07-25

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Kafrelsheikh University

#### Responsible Party

**Investigator Affiliation:** Kafrelsheikh University

**Investigator Full Name:** Tarek Ezzat Abd El Galil

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

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The aim of this research is to study and compare the efficacy and safety of bilateral single injection erector spinae plane block (ESPB) compared with intravenous patient-controlled analgesia (IV-PCA) in managing postoperative pain after radical cystectomy.

**Detailed Description:** Radical cystectomy (RC) is one of the most challenging surgical techniques in Urology. Acute postsurgical pain is frequently detrimental in a patient's recovery and quality of life.

Intravenous patient-controlled analgesia (IV-PCA) is one of the most commonly used strategies in clinical practice for controlling postoperative pain. It involves continuous administration of a programmed dose of analgesics, while also allowing patients to receive additional, need-based doses.

One such avenue is the erector spinae plane block (ESPB), a novel analgesic technique first described in 2016 by Forero et al. Although the mechanism of action of the ESPB is unknown, a proposed mechanism is via blockade of the dorsal and ventral rami of thoracic/lumbar spinal nerves. ESPB has been used as analgesia in rib fractures and other thoracic procedures as well as in abdominal surgeries.

### Conditions Module

**Conditions:**

- Erector Spinae Plane Block

- Radical Cystectomy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 60

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients received ultrasound guided bilateral single shot erector spinae pane block (ESPB) at Th10 level with 20 mL 0.25% bupivacaine after the end of surgery.

**Intervention Names:**

- Drug: Bupivacain 25% (Erector Spinae Plane Block)

**Label:** Erector Spinae Plane Block group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patients received Intravenous patient-controlled analgesia (IV-PCA) by morphine

**Intervention Names:**

- Drug: Morphine (Intravenous patient-controlled analgesia)

**Label:** Intravenous patient-controlled analgesia group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Erector Spinae Plane Block group

**Description:** Patients received ultrasound guided bilateral single shot erector spinae pane block (ESPB) at Th10 level with 20 mL 0.25% bupivacaine after the end of surgery.

**Name:** Bupivacain 25% (Erector Spinae Plane Block)

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Intravenous patient-controlled analgesia group

**Description:** Patients received intravenous patient-controlled analgesia (IV-PCA) by morphine

**Name:** Morphine (Intravenous patient-controlled analgesia)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Bolus dose of IV morphine (3mg) was provided as a rescue analgesia when the numeric rating scale (NRS) ≥ 4.

**Measure:** Total morphine consumption

**Time Frame:** 48 hours postoperatively

#### Secondary Outcomes

**Description:** Time from end of surgery to first dose of morphine administrated.

**Measure:** The time of first rescue analgesia

**Time Frame:** 48 hours postoperatively

**Description:** Pain assessment will be done at rest and during coughing or movement by numeric rating scale (NRS) from 0 to 10 where 0 means no pain and 10 being worst pain) at PACU, 2, 4, 8, 12, 16 24, 36 and 48 postoperative.

**Measure:** Degree of pain

**Time Frame:** 48 hours postoperatively

**Description:** Side effects such as hypotension, bradycardia, respiratory depression (respiratory rate \<10/minute), urinary retention and postoperative nausea and vomiting (PONV) will be recorded and managed.

**Measure:** Incidence of side effects

**Time Frame:** 48 hours postoperatively

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age of the patient between 21 to 65 years.
* Both sexes.
* Body mass index (BMI): 20 - 40 kg/m2.
* American Society of Anesthesiologists (ASA) physical status II-III.
* Elective radical cystectomy.

Exclusion Criteria:

* Patient refusal.
* Psychiatric and cognitive disorders.
* Local infection at the site of injection.
* Allergy to study medications.
* Anatomic abnormalities.
* Inability to comprehend or participate in pain scoring system.

**Maximum Age:** 65 Years

**Minimum Age:** 21 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Kafr Ash Shaykh

**Country:** Egypt

**Facility:** Kafrelsheikh University

**State:** Kafrelsheikh

**Zip:** 33516

### 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

### 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

- ID: D000000701

- Term: Analgesics, Opioid

- ID: D000009294

- Term: Narcotics

- ID: D000000700

- Term: Analgesics

### 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: M11982

- Name: Morphine

- Relevance: HIGH

- As Found: Site

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

- ID: M12245

- Name: Narcotics

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000009020

- Term: Morphine

- ID: D000002045

- Term: Bupivacaine

### Misc Info Module

- Version Holder: 2024-05-31
