## Protocol Section
### Identification Module
**NCT ID:** NCT04838379

**Brief Title:** Ultrasound Guided Rectus Sheath Block and Transversus Abdominis Plane Block

**Official Title:** Perioperative Analgesic Effect of Preemptive Ultrasound Guided Rectus Sheath Block and Transversus Abdominis Plane Block With Dexmedetomidine vs Dexamethasone for Laparoscopic Surgery in Paediatrics

#### Organization Study ID Info
**ID:** 01210861577
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2023-01-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-04-20

**Type:** ACTUAL

**Last Update Submit Date:** 2023-04-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-05-20

**Type:** ACTUAL

#### Start Date
**Date:** 2021-04-01

**Type:** ACTUAL

**Status Verified Date:** 2023-04

#### Study First Post Date
**Date:** 2021-04-09
**Type:** ACTUAL
**Study First Submit Date:** 2021-03-31
**Study First Submit QC Date:** 2021-04-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Assiut University

#### Responsible Party

**Investigator Affiliation:** Assiut University

**Investigator Full Name:** Kirolos Gamal Reda

**Investigator Title:** Principal Investigator

**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:** The current study aimed to assess the efficacy of Dexmedetomidine (DEX) and Dexamethasone as an adjuvant to ultrasound guided TAP and RS block to prolongation of postoperative analgesia and better pain control in children undergoing laparoscopic surgeries

**Detailed Description:** Laparoscopic surgeries are one of the most frequently performed paediatric surgeries . Although minimally invasive, this technique is still associated with a significant amount of pain and anxiety in children . Indeed, children who are highly anxious prior to surgery tend to have more postoperative pain, delayed hospital discharge, and higher incidence of emergence delirium, sleep disturbances, and other mal-adaptive behaviour changes that can last up to a few weeks following surgery . To improve analgesia and decrease postoperative anxiety in children undergoing laparoscopic appendectomies multimodal approach for pain control can be employed.

Over the past years, the concept of pain management has extended from simply decreasing pain intensity to optimizing patient's condition. The goal is to decrease pain scores, stress response that should be avoided in patients, particularly cardiac patients, together with a decrease in analgesics-related adverse effects like nausea, vomiting, retention of urine and over sedation. By achieving these goals, we can certainly facilitate patient recovery and minimize the hospital stay. Improved pain control can be achieved by a combination of different types of regional analgesia with systemic analgesics. The main contributor to pain post abdominal operations is the pain from abdominal wall incision .

Many procedures were followed to decrease this intense postoperative pain such as, epidural catheter analgesia, transversus abdominis plane (TAP) block, local wound infiltration, Patient-Controlled Analgesia (PCA), peripheral nerve blocks, in addition to systemic administration of Non-Steroidal Anti- Inflammatory Drugs (NSAIDs) or opioids .

The transversus abdominis plane (TAP) block is a regional anesthetic technique that provides analgesia to the parietal peritoneum as well as to the skin and muscles of the anterior abdominal wall (9-10). Despite a relatively low risk of complications and a high success rate using modern techniques, TAP block remains overwhelmingly underused. Although the technique is technically straightforward, it has not been adopted in clinical practice .

Moreover, The Rectus Sheath Block (RSB) is one of these regional techniques that are suitable for operations with a midline incision or laparoscopic surgery with the main incision at the umbilical port. A previous study showed the analgesic efficacy of ultrasound guided rectus sheath block for laparoscopic appendectomy compared to a control group injected with saline instead of a local anesthetic Generally, in laparoscopic surgeries, the sites of port incision are associated with considerable postoperative discomfort. Thus, we performed TAP and RS block to ameliorate postoperative pain and improve patient outcomes. In addition to the usefulness of traditional local anesthetics to provide analgesia during the course of the postoperative period is restricted by their short duration of action .

Dexmedetomidine (DEX) and Dexamethasone has been shown as a valuable additives to local anesthetics in neuraxial blocks and peripheral nerve blocks leading to prolongation of postoperative analgesia and better pain control .

Dexmedetomidine (DEX) α-2 adrenergic receptor consists of three α-2 isoreceptors (α-2a, α-2b and α-2c), which regulate the various pharmacodynamic effects of this drug . The α-2a receptor seems to promote sedation and anxiolysis in the locus coeruleus, as well as to generate bradycardia and peripheral vasodilation by stimulation of the cerebral vasomotor center. The α-2b receptor prevents tremor, generates analgesia in the dorsal horns of the spinal cord and determines peripheral vasoconstriction. The α-2c receptor modulates the mental state .

Dexamethasone, a high-potency, long-acting glucocorticoid, has been shown to prolong peripheral nerve blockade . Dexamethasone binds to glucocorticoid receptors and inhibits potassium conductance, which decreases nociceptive C-fiber activity . Dexamethasone may also extend the duration of analgesia via local vasoconstrictive and systemic anti-inflammatory effects .

Thus, we performed TAP and RS block to ameliorate postoperative pain and improve patient outcomes.

.

### Conditions Module

**Conditions:**

- Cholecystitis

- Appendicitis

**Keywords:**

- us guided rectus sheath block&tap block

- laparscopic surgery

- regional anesthesia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Age: 8-12years.

* Weight: 20-60 kg.
* Sex: both males and females.
* ASA physical status: I-II.

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 90

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** will include 30 patients: each one will receive 2.5 mg/kg of 0.25% bupivacaine diluted in a 20 mL syringe of normal saline, 10 minutes before skin incision

**Intervention Names:**

- Drug: Dexmedetomidine

**Label:** group Bupivacaine

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** will include 30 patients: each one will receive 2.5mg/kg of 0.25% bupivacaine plus 1 µ/kg of dexmedetomidine diluted in a 20 mL syringe of normal saline, 10 minutes before skin incision

**Intervention Names:**

- Drug: Dexmedetomidine

**Label:** group bupivacaine&dex

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** will include 30 patients: each one will receive 2.5 mg/kg of 0.25% bupivacaine plus dexamethasone (0.3 mg/kg) diluted in a 20 mL syringe of normal saline , 10 minutes before skin incision

**Intervention Names:**

- Drug: Dexmedetomidine

**Label:** Group bupivacaine & dexamethasone

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group bupivacaine & dexamethasone

- group Bupivacaine

- group bupivacaine&dex

**Description:** Ninety patients were randomized to receive ultrasound-guided RSB\&tap block After the induction of anesthesia and patient stabilization, the abdomen was sterilized and draped. Then, under complete aseptic conditions, ultrasound-guided Bilateral Rectus Sheath Block \& tap block was performed

**Name:** Dexmedetomidine

**Other Names:**

- Dexamethasone

- Bupivacaine

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** the time of the first call for analgesia is recorded

**Measure:** evaluate the first call for rescue analgesia

**Time Frame:** 24 hours after recovery from anesthesia

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* ● Age: 8-12years.

  * Weight: 20-60 kg.
  * Sex: both males and females.
  * ASA physical status: I-II.

Exclusion Criteria:

* • Patient's guardian refusal to participate in the study.

  * Patients having known hypersensitivity to dexametomidine will be excluded.
  * Patients with cardiovascular, liver or renal disease, unsatisfactory preoperative peripheral arterial oxygen saturation, neurological or psychiatric disease and coagulation disturbances.
  * Any perioperative cardiovascular or respiratory event occurred or difficulties in pain perception and assessment which make the study intervention clinically unacceptable.
  * Patients on regular use of analgesic or who received analgesic 24 h before surgery

**Maximum Age:** 12 Years

**Minimum Age:** 8 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Assiut

**Country:** Egypt

**Facility:** Assiut university

**Zip:** 71511

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000059413

- Term: Intraabdominal Infections

- ID: D000007239

- Term: Infections

- ID: D000005759

- Term: Gastroenteritis

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000002429

- Term: Cecal Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000005705

- Term: Gallbladder Diseases

- ID: D000001660

- Term: Biliary Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M6005

- Name: Cholecystitis

- Relevance: HIGH

- As Found: Cholecystitis

- ID: M25019

- Name: Acalculous Cholecystitis

- Relevance: LOW

- As Found: Unknown

- ID: M4376

- Name: Appendicitis

- Relevance: HIGH

- As Found: Appendicitis

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M29465

- Name: Intraabdominal Infections

- Relevance: LOW

- As Found: Unknown

- ID: M8875

- Name: Gastroenteritis

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5679

- Name: Cecal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8823

- Name: Gallbladder Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4946

- Name: Biliary Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1150

- Name: Cholecystitis

- Relevance: HIGH

- As Found: Cholecystitis

### Condition Browse Module - Meshes

- ID: D000001064

- Term: Appendicitis

- ID: D000002764

- Term: Cholecystitis

### Intervention Browse Module - Ancestors

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000000932

- Term: Antiemetics

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000005938

- Term: Glucocorticoids

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000779

- Term: Anesthetics, Local

- ID: D000000777

- Term: Anesthetics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000018689

- Term: Sensory System Agents

- ID: D000006993

- Term: Hypnotics and Sedatives

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000058647

- Term: Adrenergic alpha-2 Receptor Agonists

- ID: D000000316

- Term: Adrenergic alpha-Agonists

- ID: D000000322

- Term: Adrenergic Agonists

- ID: D000018663

- Term: Adrenergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Analg

- Name: Analgesics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

### Intervention Browse Module - Browse Leaves

- ID: M7102

- Name: Dexamethasone

- Relevance: HIGH

- As Found: Children

- ID: M22662

- Name: Dexmedetomidine

- Relevance: HIGH

- As Found: Twice daily

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M5315

- Name: Bupivacaine

- Relevance: HIGH

- As Found: Following

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M235549

- Name: Dexamethasone acetate

- Relevance: LOW

- As Found: Unknown

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4251

- Name: Antiemetics

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9047

- Name: Glucocorticoids

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

- ID: M10043

- Name: Hypnotics and Sedatives

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M20746

- Name: Adrenergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M3668

- Name: Adrenergic alpha-Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M3673

- Name: Adrenergic Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000003907

- Term: Dexamethasone

- ID: D000020927

- Term: Dexmedetomidine

- ID: D000002045

- Term: Bupivacaine

### Misc Info Module

- Version Holder: 2024-05-24
