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
|
|
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
|
|
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
- 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).
- 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
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - by publication. data will be with principle investigator and guide
- 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.
- 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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