## Protocol Section
### Identification Module
**NCT ID:** NCT06224179

**Acronym:** U/STAP

**Brief Title:** Role of Ultrasound Guided Transversus Abdominis Plane Block in Pain Control After Hepatectomy

**Official Title:** Ultrasound Guided Oblique Subcostal Transversus Abdominis Plane Block(TAP) Versus Both Subcostal and Posterior TAP Block as Postoperative Analgesia in Hepatectomy

#### Organization Study ID Info
**ID:** M S 96/2021
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams University
### Status Module
#### Completion Date
**Date:** 2024-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-01-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-01-29

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-05-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-02-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2024-01-25
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-17
**Study First Submit QC Date:** 2024-01-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ain Shams University

#### Responsible Party

**Investigator Affiliation:** Ain Shams University

**Investigator Full Name:** Ahmed wagih Ezzat deusouky

**Investigator Title:** lecturer of anesthesia

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Inadequately managed acute pain following abdominal surgery originates from somatic pain signals in the abdominal wall and is linked to various unfavorable postoperative outcomes. These consequences encompass patient distress, respiratory complications, delirium, myocardial ischemia, extended hospital stays, an elevated risk of chronic pain, heightened analgesic consumption, delayed bowel function, and an increased need for rescue analgesics.

This study aims to assess the postoperative analgesic efficacy of ultrasound-guided Transversus Abdominis Plane (TAP) block using oblique subcostal and posterior approaches in hepatectomy.

**Detailed Description:** Pain control is vital to achieve enhanced recovery after abdominal surgeries . TAP block had been demonstrated to improve pain related outcomes after abdominal surgeries.

Postoperative pain management for patients undergoing hepatic resection is a challenge due to the risk of perioperative liver dysfunction.TAP block is a promising regional analgesic technique. This study aimed to evaluate the effect of US-guided subcostal approach versus combination of both subcostal and posterior approaches of TAP block

The patients will be randomly divided into two groups :

group A will recieve oblique subcostal TAP block and group B will recieve both subcostal and posterior TAP block .

### Conditions Module

**Conditions:**

- Analgesia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Group A received ultrasound guided subcostal TAP block with 30 ml of local anesthetics and additives

**Intervention Names:**

- Procedure: ultrasound guided subcostal TAP block

**Label:** Group A

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Group B received ultrasound guided both subcostal and posterior TAP block with 30 ml of local anesthetics and additives at each side

**Intervention Names:**

- Procedure: ultrasound guided combined posterior and subcostal TAP block

**Label:** Group B

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group A

**Description:** patients will be randomly divided into two groups using a computer generated random number chart.

Group A received ultrasound guided subcostal TAP block,

**Name:** ultrasound guided subcostal TAP block

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Group B

**Description:** patients will be randomly divided into two groups using a computer generated random number chart.

Group B received ultrasound guided combined posterior and subcostal TAP block,

**Name:** ultrasound guided combined posterior and subcostal TAP block

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Pain will be assessed on admission and at 2, 4, 8, 12 and 24 hours at rest and with passive flexion of hip and knee joint using visual analogue scale (VAS) ranging from 0 for no pain to 10 for worst pain.

**Measure:** postoperative analgesia (VAS) during the 1st 24 hours in ICU

**Time Frame:** 24 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* ASA I and II patients. aged 18 to 50 years. 70 to 80 kg.

Exclusion Criteria:

* patients under 18 years of age.

  * History of Allergic reactions to study drugs.
  * Opioid or analgesic abuse, and chronic treatment with opioids, or non-steroidal anti-inflammatory drugs.
  * History of bleeding tendency or coagulopathy .

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** a_wagih82@yahoo.com

**Name:** Ahmed El-Dolah, lecturer of Anesthesia

**Phone:** +20111113077

**Role:** CONTACT

## 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: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
