Mid-transverse Process to Pleura Block in Pediatric Thoracotomy

NCT ID: NCT05999734

Last Updated: 2024-01-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2024-09-30

Brief Summary

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

Detailed 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.

Conditions

Ultrasound Guided Block; Pediatric Surgery; Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Patients undergoing pediatric thoracotomy will receive general anesthesia alone.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

general anesthesia and ultrasound guided MTP block

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Mid transverse process to pleural block

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Heba Salah Eldin Gawish

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Heba Gawish, Master

Role: CONTACT

Hebasalah78100@gmail.com

01069914549

Mohammed Shebl Abdelghany, MD

Role: CONTACT

+20 106 334 5623

Other Identifiers

MTP block

Identifier Type: -

Identifier Source: org_study_id