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CTRI Number  CTRI/2023/12/060885 [Registered on: 28/12/2023] Trial Registered Prospectively
Last Modified On: 07/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to assess postoperative analgesic effects of ultrasound guided Quadratus lumborum block with dexmedetomidine in children undergoing laparoscopic surgeries 
Scientific Title of Study   Efficacy of ultrasound guided Quadratus lumborum block with dexmedetomidine in providing postoperative analgesia after laparoscopic surgeries in children - A randomised control trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kanishka S 
Designation  2nd year postgraduate resident M.D Anaesthesiology 
Affiliation  Sri Ramachandra Medical College and Research Institute 
Address  Room number A6, Department of Anaesthesiology, Sri Ramachandra Medical College and Research Institute, Sri Ramachandra nagar, Porur, Chennai 600116

Chennai
TAMIL NADU
600116
India 
Phone  8939299157  
Fax    
Email  kanish28051997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aruna Parameswari 
Designation  Professor and Head of the Department, Department of Anaesthesiology 
Affiliation  Sri Ramachandra Medical College and Research Institute 
Address  Room number A6, Department of Anaesthesiology, Sri Ramachandra Medical College and Research Institute, Sri Ramachandra nagar, Porur, Chennai 600116

Chennai
TAMIL NADU
600116
India 
Phone  09840529863  
Fax    
Email  hod.anaesthesiology@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Aruna Parameswari 
Designation  Professor and Head of the Department, Department of Anaesthesiology 
Affiliation  Sri Ramachandra Medical College and Research Institute 
Address  Room number A6, Department of Anaesthesiology, Sri Ramachandra Medical College and Research Institute, Sri Ramachandra nagar, Porur, Chennai 600116

Chennai
TAMIL NADU
600116
India 
Phone  09840529863  
Fax    
Email  hod.anaesthesiology@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
Sri Ramachandra Medical College and Research Institute, Sri Ramachandra Nagar, Porur, Chennai 600116 
 
Primary Sponsor  
Name  Kanishka S 
Address  Room number A6, Department of Anaesthesiology, Sri Ramachandra Medical College and Research Institute, Sri Ramachandra nagar, Porur, Chennai 600116 
Type of Sponsor  Other [Self financing] 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrKanishka S  Sri Ramachandra Medical College and Research Institute  Room number A6, Department of Anaesthesiology, Sri Ramachandra Medical College and Research Institute, Sri Ramachandra nagar, Porur, Chennai 600116
Chennai
TAMIL NADU 
8939299157

kanish28051997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sri Ramachandra Medical College and Research Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N432||Other hydrocele, (2) ICD-10 Condition: Q632||Ectopic kidney, (3) ICD-10 Condition: N832||Other and unspecified ovarian cysts, (4) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis, (5) ICD-10 Condition: O||Medical and Surgical, (6) ICD-10 Condition: K429||Umbilical hernia without obstruction or gangrene, (7) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (8) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (9) ICD-10 Condition: K458||Other specified abdominal hernia without obstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ultrasound guided Quadratus lumborum block with bupivacaine and dexmedetomidine  0.8ml/kg of 0.25% Bupivacaine with 1 microgram/kg of dexmedetomidine with appropriate amount of saline given after induction of general anesthesia before port site incision. Intraoperatively and postoperative period till 36 hours patient will be monitered. 
Comparator Agent  Ultrasound guided Quadratus Lumborum block with plain bupivacaine  0.8ml/kg of 0.25% Bupivacaine with appropriate amount of saline given after induction of general anesthesia before the port site incision. intraoperatively and postoperative period till 36 hours patient will be monitered. 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  17.00 Year(s)
Gender  Both 
Details  All children ASA1/2 posted for elective laparoscopic surgeries will be included in the study 
 
ExclusionCriteria 
Details  1. ASA 3/4
2. History of liver and renal disorders
3. Coagulopathies and bleeding disorder
4. Infection at injection site
5. Allergy to local anaesthetic/ paracetamol
6. Patient and Guardian refusal
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Time to first analgesic  1. Time from block given till patient has a pain score of more than 3 is observed.
2. Pain scores will be assessed from 0,5,10,30 minutes, 1,1.5,2,6,12,18,24,36 hours post extubation.
3. patient has a pain score of more than 3 within 6 hours of paracetamol, he/ she
will be given Ibuprofen 7 mg/kg body weight. 
 
Secondary Outcome  
Outcome  TimePoints 
Post operative pain scores  Every 5 minutes post extubation, at 30 minutes, 1 hour, 1 1/2 hours, 2 hours, 6 hours, 12 hours,18 hours, 24 hours, 36 hours post extubation 
Total paracetamol doses  Total number of paracetamol doses given in the first 36 hours post block
 
Requirement of rescue analgesic  Requirement of rescue analgesic Ibuprofen 7mg/kg in addition to paracetamol if pain score more than 3 during 36 hours post block
 
Intraoperative & Postoperative complications  during intraoperative & in postoperative period Incidence of bradycardia, hypotension, respiratory depression, vomiting & pruritis will be noted 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="44" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   04/01/2024 
Date of Study Completion (India) 06/05/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  by publication. data will be with principle investigator and guide

  6. For how long will this data be available start date provided 31-10-2023 and end date provided 31-10-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary
Modification(s)  

Quadratus lumborum block has shown to provide longer and more effective postoperative analgesia compared with the transversus abdominis plane block and caudal block  in children. Dexmedetomidine is a highly selective α2 agonist, with sympatholytic, sedative, anxiolytic and analgesic which acts by decreasing sympathetic central nervous outflow without the systemic side effects of opioids such as nausea, vomiting, respiratory depression, urinary retention, and pruritus. This study aims to evaluate effectiveness of ultrasound guided Quadratus lumborum block with dexmedetomidine as adjuvant in children undergoing Laparoscopic surgeries. The objective of study is to assess the time to first analgesic, postoperative pain scores, need for rescue analgesia, duration of block action and complications related to quadratus lumborum block with dexmedetomidine. 

After obtaining Institution Ethics Committee approval - patient who fit into inclusion criteria will be enrolled into the study after obtaining informed consent from the patient’s guardian. 

Patients will be randomly allocated to two groups by using computer generated random table. 

GROUP A : 0.8 ml/kg of 0.25% bupivacaine for USG - guided Quadratus lumborum block with 1 mcg/kg of dexmedetomidine diluted with appropriate amount of saline 

GROUP B : 0.8 ml/kg of 0.25% bupivacaine for USG – guided Quadratus lumborum block with appropriate amount of saline

Once the patient is wheeled into the holding area, baseline vitals – heart rate, oxygen saturation, blood pressure will be monitored. Block performence time, time from block given to incision, Duration of surgery will be noted down. 

All children under 18 years coming for laparoscopic surgery will be premedicated with midazolam 0.5 mg/kg orally if required. Inhalational induction with Sevoflurane by mask 8% in 6L/min of O2 as FGF, IV secured. Inj. fentanyl 2 mg/kg IV, appropriate size enotracheal intubation will be done and secured after confirming air entry, anesthesia will be maintained with O2 and air and sevoflurane. Patient’s eyes will be adequately padded. Patients in both groups will received bilateral quadratus lumborum block according to the group allocation. Vitals will be monitered intraoperatively. 3 values will be recorded intraoperatively for 10 minutes post port insertion. 15mg/kg body weight Paracetamol will be given intraoperatively 30 minutes before extubation.

Postoperative pain will be assessed by FLACC scale in children upto 7 years and visual analogue scale for children from 7 years to 18 years, Postoperative sedation will be assessed by ramsey sedation score. immediately after extubation and at 5 minutes and 10 minutes post extubation, every 30 min in PACU for 2 hours and every 6 hours till 36 hours. The heart rate, pain scores and oxygen saturation will be monitored. Patients requirement of supplemental analgesic noted. FLACC or VAS Pain score more than 3 - Paracetamol 15mg/kg will be given. in case of incidence of pain within 6 hours of paracetamol, ibuprofen 7mg/kg will be given as rescue analgesic.

Routine postoperative vital data will be taken and the incidence of postoperative complications as hypotension, bradycardia, vomiting, pruritis and respiratory depression (respiratory rate less than 10 breathes/min) will be recorded. 

This study will help us promote better methods of postoperative and intraoperative analgesia and reduce opioid requirements and thereby opioid related complications in pediatric population


 
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