Ultrasound Guided Rectus Sheath Block and Transversus Abdominis Plane Block

NCT04838379 | Completed DMC

• 1 other identifier: 01210861577
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Cholecystitis; Appendicitis

Keywords

us guided rectus sheath block&tap block; laparscopic surgery; regional anesthesia

Outcome Measures

Primary Outcomes (1)

• evaluate the first call for rescue analgesia

  the time of the first call for analgesia is recorded

  24 hours after recovery from anesthesia

Study Arms (3)

group Bupivacaine

PLACEBO COMPARATOR

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

Drug: Dexmedetomidine

group bupivacaine&dex

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine

Group bupivacaine & dexamethasone

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

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

Also known as: Dexamethasone, Bupivacaine

Group bupivacaine & dexamethasone; group Bupivacaine; group bupivacaine&dex

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ● Age: 8-12years.
• Weight: 20-60 kg.
• Sex: both males and females.
• ASA physical status: I-II.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, 71511, Egypt

Location

MeSH Terms

Conditions

Cholecystitis; Appendicitis

Interventions

Dexmedetomidine; Dexamethasone; Bupivacaine

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Age: 8-12years. * Weight: 20-60 kg. * Sex: both males and females. * ASA physical status: I-II.

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 9, 2021
• Study Start: April 1, 2021
• Primary Completion: May 20, 2022
• Study Completion: January 2, 2023
• Last Updated: April 20, 2023

Record last verified: 2023-04

Locations

EG (1)