Mid-transverse Process to Pleura Block in Pediatric Thoracotomy

Analgesia Clinical Trial

Official title:

Ultrasound-Guided Mid-Transverse Process to Pleura Block for Analgesia in Pediatric Thoracotomy: A Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05999734
• Other study ID #: MTP block
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: September 2024

Study information

• Verified date: January 2024
• Source: Tanta University
• Contact: Heba Gawish, Master
• Phone: 01069914549
• Email: Hebasalah78100[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Pain following surgery is a universal phenomenon which up to now is often underestimated and undertreated especially in pediatrics. Any postoperative analgesic technique should meet three criteria, which are effectiveness, universal applicability and safety.

Thoracotomy is widely known to cause severe acute pain. This pain can be very distressing for both children and their parents. If not treated properly, it may acutely cause ventilation-perfusion disorder and hypoxemia, together with a change in lung mechanics. It may lead to a delay in recovery, with some long-term sequelae. As a part of multimodal analgesia, many regional blocks have been described.

Regional anesthesia techniques are increasingly used in all surgical settings. Even in the context of thoracic surgery, new peripheral regional anesthesia techniques are being tested as alternatives to those already used. This proliferation of new techniques is explained, on the one hand, by the evolution of surgical techniques, which are becoming less and less invasive, and on the other hand, by the frequency and severity of the complications induced by thoracic epidural anesthesia and paravertebral block - currently the gold standards in context of pediatric setting.

Paravertebral block (PVB) has gained more popularity than other regional analgesic techniques including epidural for perioperative analgesia in pediatric surgery. Thoracic PVB provides adequate postoperative analgesia with favorable adverse effects. The use of thoracic PVB is associated with decreased pain severity and opioid consumption in both adults and children.

Many clinicians hesitate to apply the PVB technique due to the risk of serious complications such as pneumothorax. Therefore, the safest and most effective methods are being tried by clinicians. In a study conducted on cadavers claimed that mid-transverse process to pleura (MTP) block (an injection point midway between the pleura and posterior border of the transverse process) provides a paravertebral block due to the paravertebral spread of the local anesthetic agent through fenestrations and septations in the superior costotransverse ligament. They thought that MTP block may be as effective as PVB in postoperative pain management with less risk of possible complications.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Refusal of parents.

• Repeated thoracotomy.

• Emergency surgery.

• Mechanically ventilated patients.

• Bleeding disorders.

• Allergy to study drugs.

• Infection at the site of the needle puncture.

Related Conditions & MeSH terms

• Analgesia
• Pediatric Surgery
• Ultrasound Guided Block

Intervention

Drug:
• Bupivacaine
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	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.The scale is scored in a range of 0 to 10 with 0 representing no pain, 10 representing the maxim	1, 2, 6, 12, 18 and 24 hours postoperative.
Secondary	Total intraoperative fentanyl consumption (µ/kg) starting from induction of anesthesia till the end of surgery.	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.
Secondary	Diaphragmatic excursion will be measured preoperative and postoperative in post anesthesia care unit (PACU).	Diaphragmatic excursion will be measured preoperative and postoperative in post anesthesia care unit (PACU).	Immediately 15 minutes preoperative and 15 minutes postoperative