Viewing Study NCT04838379



Ignite Creation Date: 2024-05-06 @ 4:00 PM
Last Modification Date: 2024-10-26 @ 2:01 PM
Study NCT ID: NCT04838379
Status: COMPLETED
Last Update Posted: 2023-04-20
First Post: 2021-03-31

Brief Title: Ultrasound Guided Rectus Sheath Block and Transversus Abdominis Plane Block
Sponsor: Assiut University
Organization: Assiut University

Study Overview

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
Status: COMPLETED
Status Verified Date: 2023-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 patients 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None