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Retrolaminar Block for Pediatric Thoracoscopic Sympathectomy

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ClinicalTrials.gov Identifier: NCT04688918
Recruitment Status : Recruiting
First Posted : December 30, 2020
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Mahmoud Mohammed Alseoudy, Mansoura University

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.

Condition or disease Intervention/treatment Phase
Pediatric Thoracoscopy Procedure: Retrolaminar block Procedure: paravertebral group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, double blind study
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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
Primary Purpose: Treatment
Official Title: Ultrasound-guided Retrolaminar Block Versus Paravertebral Block for Postoperative Analgesia in Children Undergoing Thoracoscopic Sympathectomy: a Non-inferiority Study
Actual Study Start Date : January 3, 2021
Estimated Primary Completion Date : July 15, 2021
Estimated Study Completion Date : August 20, 2021

Arm Intervention/treatment
Active Comparator: Group A (Retrolamianar block(RLB))
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
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.

Active Comparator: Paravertebral group
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
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




Primary Outcome Measures :
  1. morphine consumption [ Time Frame: Up to 24 hours after the procedure ]
    The total dose of morphine consumed in first 24 hours will be recorded (mg)


Secondary Outcome Measures :
  1. pain score [ Time Frame: Up to 24 hours after the procedure ]
    Pain levels will be assessed post operatively using visual analogue scale(vas),usually 10 centimeters (100 mm) in length, For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]),vas measured at 0,1, 2, 4, 6, 12, 24 hours

  2. number of patients who will need analgesia [ Time Frame: Up to 24 hours after the procedure ]
    number of patients who request analgesia in the postoperative period

  3. Block related complications [ Time Frame: Up to 24 hours after the procedure ]
    Block related complications (pneumothorax, local anesthetic toxicity or hematoma).[

  4. time of first analgesic request (min) [ Time Frame: Up to 24 hours after the procedure ]
    the time of first analgesic request in first 24 hours



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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04688918


Locations
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Egypt
Department of Anesthesia, Mansoura University Hospitals Recruiting
Mansoura, Dakahlia, Egypt, 35511
Contact: Sameh M El-Sherbiny, MD    +201006500748    Smfsherbiny@yahoo.com   
Sub-Investigator: Sameh M El-Sherbiny, MD         
Principal Investigator: Amany H El-Deeb, MSc         
Sponsors and Collaborators
Mansoura University
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Responsible Party: Mahmoud Mohammed Alseoudy, Lecturer of anesthesia, ICU & pain management; Faculty of Medicine, Mansoura University
ClinicalTrials.gov Identifier: NCT04688918    
Other Study ID Numbers: R.20.12.1115
First Posted: December 30, 2020    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No