Retrolaminar Block for Pediatric Thoracoscopy

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

Study Description

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

Detailed Description:

Video assisted thoracoscopic surgery (VATS); a minimally invasive (keyhole) surgical procedure allows the surgeon to directly examine the inside of thoracic cavity without a big incision and thereby avoids extensive damage to the chest wall and offers the advantages of a smaller incision, less postoperative pain and a faster postoperative recovery as compared with thoracotomy.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.The introduction of anatomy-based ultrasound (US) imaging for facilitating nerve localization is a major advancement in the field of pediatric regional anesthesia. This is because regional anesthesia techniques are challenging to perform in children as a result of: (a) Close proximity to critical structures, (b) The need for sedation or general anesthesia masking potential warning signs (paresthesia), and (c) The potential hazards of local anesthetic toxicity due to overdose.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.The sensory innervation of anterolateral chest wall occurs via the lateral and anterior cutaneous branches of the thoracic intercostal nerves (T2-T12). Targeting the deep serratus anterior plane also aims to avoid blockade of the long thoracic nerve which runs in the superficial serratus plane, and which would have resulted in a winging of the scapulaThis 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. This prospective double blinded controlled randomized study will be carried out in Mansoura university children hospital (MUCH) after obtaining approval from Mansoura Faculty of Medicine Institutional Research Board. An informed written consent will be obtained from the patient guardians'. The planned duration of this study is one year. Time gap of the study will be from January 2021 to July 2022.

Eighty children of American Society of Anesthesiologists physical status I-II of either sex with their age ranging from 8 to 18 years undergoing thoracoscopic surgeries will be recruited for the study.Exclusion criteria will include history of clinically significant cardiac, hepatic, renal, or neurological dysfunction, coagulopathy, known allergy to amide local anesthetics and local infection at injection sites.A prior G-power analysis is done to estimate the sample size. The primary outcome of this study will be the time to first rescue analgesia. Using fisher's exact test and assuming alpha (type I error) = 0.05 and beta (type II error) = 0.2 (power =80%), 35 patients per group will be sufficient to detect a difference of 60 min in time to first rescue analgesia between the two groups. Forty patients will be included per group to replace any dropouts.General anesthesia will be induced with incremental sevoflurane in 100% oxygen. After reaching an adequate depth of anesthesia, a venous access was established, and then vecuronium will be given in a dose of 0.6 mg/kg and ETT will be inserted. Anesthesia was maintained under controlled ventilation with 1-1.5 MAC of isoflurane and 0.1 mg/kg vecuronium every 30 minutes as muscle relaxant. Standard intraoperative monitors will be applied for measurement of ECG, heart rate, pulse oximetry, noninvasive blood pressure, and end-tidal carbon dioxide concentration. Baseline readings will be recorded.Computer-generated random numbering of the studied patients will be used for patient randomization before surgery. Opaque sealed envelope will be used and opened in the operative theatre by an anesthesiologist who will not involved in the current study and who will prepare the drugs used in the study. Anesthesiologist who will be responsible of the patient and the nurse who recorded the patient data will be unaware of patient's group. Patients will be randomly allocated to one of two equal groups (40 patients for each). Control group (n=40): the patients will receive a placebo. TRLB block group (n=40): ultrasound guided thoracic retrolaminar block (TRLB).All blocks will be performed by the same anesthetist who is experienced in US-guided pediatric nerve blocks.. A high-resolution (M-turbo; Fujifilm Snosite Inc., Bothell, Washington, USA) 5-12 MHz linear probe with a sterile cover will be used to perform the block. All surgical procedures will be performed by the same surgical team.All blocks will be performed by the same anesthetist who is experienced in US-guided pediatric nerve blocks.. A high-resolution (M-turbo; Fujifilm Snosite Inc., Bothell, Washington, USA) 5-12 MHz linear probe with a sterile cover will be used to perform the block. All surgical procedures will be performed by the same surgical team.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. Vital signs will be recorded every 5 min after the block to ensure adequacy of the blockade especially after surgical incision. Surgical procedures will be allowed to start 20 min after performance of the block. In case of increase in either patient heart rate or respiratory rate to more than 20% of the baseline, fentanyl at 1 ug/kg will be administered. More than 30% decrease in heart rate and systolic blood pressure, respectively, as compared with the baseline values will be treated with atropine or ephedrine as appropriate but the postoperative data of those patients will not be included in the statistical analysis.After completion of surgery, children will be transferred to the post anesthesia care unit (PACU) for continuous monitoring of vital signs and for pain assessment. Children will be monitored every 15 min during the first hour in the PACU and every 30 min in the daycare unit until discharge from the hospital. Postoperative analgesia will be measured using vas score 0, 1, 2, 4, 6, 12, 18, 24 hours after surgery. Patients with vas>3 will be given rescue analgesia with 0.05mg/kg morphine intravenously. The primary outcome measure is the total morphine consumption in the first postoperative 24 h. The secondary outcome measures are Postoperative pain score, Time to first rescue analgesia and its frequency, Parents satisfaction. Block related complications (pneumothorax, local anesthetic toxicity or hematoma) and frequency of Nausea and vomiting. Data will be analyzed through SPSS (Statistical Package for Social Sciences). Program version 22. Distribution of data will be first tested by Shapiro test. Data will be presented as mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, unpaired t test will be used to compare between mean values of both groups. For pain score, Mann Whitney U test will be used. Fisher's exact test will be used for comparison of categorical data. The P value ≤ 0.05 will be considered as the level of statistical significance.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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).[

Eligibility Criteria

• 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

Contacts and Locations

No Contacts or Locations Provided

More Information

• 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
• Last Update Posted: December 30, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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