Retrolaminar Block for Pediatric Thoracoscopic Sympathectomy

NCT04688918 | Unknown

• 1 other identifier: R.20.12.1115
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Thoracoscopic sympathectomy is a rapid and simple technique associated with rare complications, but it is associated with severe postoperative pain that makes breathing and coughing difficult resulting in increased occurrence of pulmonary complications. Paravertebral block has frequently been performed for this procedure but its technical difficulty and safety profile may represent a limitation of its routine use. This prospective, randomized, double-blind controlled study is designed to compare the postoperative analgesic efficacy of ultrasound-guided thoracic retrolaminar block (TRLB) with the paravertebral block in children undergoing thoracoscopic sympathectomy. We hypothesize that ultrasound-guided thoracic retrolaminar block may comparable analgesic effect to paravertebral block with a lesser incidence of complications in pediatric patients undergoing thoracoscopic sympathectomy.

Conditions

Pediatric Thoracoscopy

Outcome Measures

Primary Outcomes (1)

• morphine consumption

  The total dose of morphine consumed in first 24 hours will be recorded (mg)

  Up to 24 hours after the procedure

Secondary Outcomes (4)

• pain score

  Up to 24 hours after the procedure

• number of patients who will need analgesia

  Up to 24 hours after the procedure

• Block related complications

  Up to 24 hours after the procedure

• time of first analgesic request (min)

  Up to 24 hours after the procedure

Study Arms (2)

Group A (Retrolamianar block(RLB))

ACTIVE COMPARATOR

Ultrasound-guided RLB with injection of 0.4ml/kglocal anesthestic (bupivacaine) 0.25%will be performed under strict aseptic precautions with ultrasound guidance with patient in the prone position.

Procedure: Retrolaminar block

Paravertebral group

ACTIVE COMPARATOR

Ultrasound-guided paravertebral injection of 0.4ml/kg saline 0.9% will be performed under strict aseptic precautions under ultrasound guidance with patient in the prone position.

Procedure: paravertebral group

Interventions

Retrolaminar block PROCEDURE

A high-resolution 5-12 MHz linear probe with a sterile cover will be used to perform the block. The patient will be placed in a prone position with a pillow under the chest. The spinous process of the fourth thoracic vertebrae will be identified and marked. Under complete sterilization, the ultrasound high frequency linear probe will be placed in a para-sagittal position, just lateral to the spinous processes of thoracic vertebra, to identify the vertebral lamina. A 50 mm 22-gauge needle will be inserted in an in-plane technique from cranial to caudal direction and will be advanced till hitting the laminae of fourth thoracic vertebrae and then we will try to inject the local anesthetic, if the resistance to injection is very high, hence we will withdraw the needle slowly and its tip will be kept in its position immediately after disappearance this high resistance. Bupivacaine 0.25%, 0.4mL/kg will be injected.

Group A (Retrolamianar block(RLB))

paravertebral group PROCEDURE

A high-resolution 5-12 MHz linear probe with a sterile cover will be used to perform the block. The patient will be placed in a prone position with a pillow under the chest. The transverse process of the fourth thoracic vertebrae will be identified and marked. Under complete sterilization, the ultrasound high frequency linear probe will be placed in a para-sagittal position, just lateral to the spinous processes of thoracic vertebra, to identify the vcostotransverse ligament, 0.4mL/kg will be injected

Paravertebral group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) status: 1 or 2
• thoracoscopic sympathectomy

You may not qualify if:

• history of clinically significant cardiac, hepatic, renal, or neurological dysfunction
• coagulopathy
• known allergy to amide local anesthetics
• local infection at injection sites

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study subjects and the resident assessing the outcomes will be blinded to the study group. A single investigator will assess the patients for eligibility, obtain written informed consent, open the sealed opaque envelopes containing group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia, ICU & pain management; Faculty of Medicine

Model Details: Prospective, randomized, double blind study

Study Record Dates

• First Submitted: December 19, 2020
• First Posted: December 30, 2020
• Study Start: January 3, 2021
• Primary Completion: November 15, 2023
• Study Completion: December 20, 2023
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)