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Retrolaminar Block for Pediatric Thoracoscopy

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ClinicalTrials.gov Identifier: NCT04688918
Recruitment Status : Not yet recruiting
First Posted : December 30, 2020
Last Update Posted : December 30, 2020
Sponsor:
Information provided by (Responsible Party):
Mahmoud Mohammed Alseoudy, Mansoura University

Brief Summary:

Video-assisted thoracoscopic surgery (VATS) has been widely used recently for its many advantages such as minimal invasiveness, marked reduction in post- operative pain, faster recovery rate and superior cosmetic results. Recently, the use of VATS in pediatric patients is increasing due to refinements in the technique, improvements in instrumentation, and advances in pediatric anesthesia .

Postoperative pain control for pediatric surgeries is a major issue and affects the quality of recovery, parental satisfaction, and surgical success. Opioid usage for pediatric analgesia has many disadvantages, such as postoperative vomiting, pruritus, respiratory depression, and sedation. Ultrasound guided thoracic retrolaminar block (TRLB) is a safe and simple alternative to thoracic paravertebral block . In adults, the analgesic efficacy of TRLB has been reported in rib fracture , breast surgery and transcatheter aortic valve replacement. Retrolaminar injection of a local anesthetic blocks ventral and dorsal rami of thoracic spinal nerves and the local anesthetic spreads laterally in the interfascial plane to block the lateral cutaneous branch of intercostal nerve and the small branches arising from it. This prospective, randomized, double blind controlled study is designed to compare the postoperative analgesic efficacy of ultrasound guided thoracic retrolaminar block (TRLB) with a placebo in children undergoing thoracoscopic surgeries. We hypothesize that ultrasound guided thoracic retrolaminar block may provide longer and more effective postoperative analgesia when compared with a placebo in pediatric inguinal surgeries.


Condition or disease Intervention/treatment Phase
Pediatric Thoracoscopy Procedure: Retrolaminar block Procedure: placebo 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: Effect of Retrolaminar Block on Postoperative Analgesia in Children Undergoing Thoracoscopic Surgeries
Estimated Study Start Date : January 5, 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.

Placebo Comparator: Placepo group
Ultrasound-guided retrolaminar 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: placebo 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 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.saline, 0.4mL/kg will be injected




Primary Outcome Measures :
  1. First analgesic request [ Time Frame: Up to 24 hours after the procedure ]
    The time of the first analgesic request will be recorded


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).[



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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 surgery

Exclusion Criteria

  • history of clinically significant cardiac, hepatic, renal, or neurological dysfunction
  • coagulopathy
  • known allergy to amide local anesthetics
  • local infection at injection sites
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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: December 30, 2020
Last Verified: December 2020
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