Mid-transverse Process to Pleura Block in Pediatric Thoracotomy

NCT05999734 | Unknown DMC

• 1 other identifier: MTP block
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to assess the effectiveness of analgesia of US guided MTP block in pediatrics undergoing thoracotomy.

Conditions

Ultrasound Guided Block; Pediatric Surgery; Analgesia

Outcome Measures

Primary Outcomes (1)

• The total dose of morphine consumption in the first postoperative 24 hours.

  The total dose of morphine consumption in the first postoperative 24 hours.

  24 hours postoperative

Secondary Outcomes (3)

• Pain will be assessed by the face, legs, activity, cry and consolability (FLACC) score in children at 1, 2, 6, 12, 18 and 24 hours postoperative.

  1, 2, 6, 12, 18 and 24 hours postoperative.

• Total intraoperative fentanyl consumption (μ/kg) starting from induction of anesthesia till the end of surgery.

  from induction of anesthesia till the end of surgery.

• Diaphragmatic excursion will be measured preoperative and postoperative in post anesthesia care unit (PACU).

  Immediately 15 minutes preoperative and 15 minutes postoperative

Study Arms (2)

Patients undergoing pediatric thoracotomy will receive general anesthesia alone.

NO INTERVENTION

the patients will receive general anesthesia alone. Anesthesia will be induced by inhalation of sevoflurane at 8% concentration which will decreased gradually down to 2% concentration carried by 100% oxygen, with loss of consciousness; a peripheral intra venous cannula with suitable size will be inserted, then the neuromuscular blockade will be facilitated by cisatracurium 0.15 mg/ kg to allow tracheal intubation with appropriate sized endotracheal tube. Fentanyl 1μg/ kg will be given and anesthesia will be maintained with air and O2 (50:50) and along with 2% end tidal concentration of sevoflurane to control the depth of anesthesia. At the end of surgery residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), and extubation will be performed after complete recovery of the airway reflexes.

general anesthesia and ultrasound guided MTP block

ACTIVE COMPARATOR

midpoint between the transverse process and the pleura 0.5mL/kg 0.25% bupivacaine will be injected.

Drug: Bupivacaine

Interventions

Bupivacaine DRUG

Before skin incision, under complete aseptic precautions and sterilization, the patient will be placed in a lateral position. The spinous process of the fourth thoracic vertebra will be identified and marked. The ultrasound guided MTP block will be done by high frequency linear transducer will be placed in position just lateral to the spinous processes of thoracic vertebra target of the paravertebral space. A 50 mm 22-gauge echogenic needle will be inserted in an in plane technique from a caudal to a cephalad direction and will be advanced. When the needle tip reaches the midpoint between the transverse process and the pleura, 1 ml normal saline will be injected. Once the needle tip has been confirmed and after careful aspiration to demonstrate the absence of air or blood, 0.5mL/kg 0.25% bupivacaine will be injected.

Also known as: Mid transverse process to pleural block

general anesthesia and ultrasound guided MTP block

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The study will include 50 pediatric patients of both sexes aged from 5 to 15 years old with American Society of Anesthesiologists physical status I\& II undergoing elective open thoracotomy.

You may not qualify if:

• Refusal of parents.
• Repeated thoracotomy.
• Emergency surgery.
• Mechanically ventilated patients.
• Bleeding disorders.
• Allergy to study drugs.
• Infection at the site of the needle puncture.

Sponsors & Collaborators

• Tanta University: lead

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Heba Gawish, Master

CONTACT

01069914549; Hebasalah78100@gmail.com

Mohammed Shebl Abdelghany, MD

CONTACT

+20 106 334 5623

Study Design

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

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 21, 2023
• Study Start: January 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share