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Posterior Quadratus Lumborum Block Using 0.125% Versus 0.25% Bupivacaine for Analgesia in Children Undergoing LPEC

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Bupivacaine hydrochloride
Sponsored by
Queen Sirikit National Institute of Child Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

1 Year - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children scheduled for laparoscopic percutaneous extraperitoneal closure(LPEC) for pediatric inguinal hernia and hydrocele
  • ASA I-II physical status patients
  • Complete inform consent for intervention

Exclusion Criteria:

  • Contraindication for regional anesthesia
  • Sensitive to local anesthetic agent, opioid or acetaminophen
  • Previous history of abdominal surgery
  • History of neuromuscular disease
  • G6PD deficiency

Sites / Locations

  • Queen Sirikit National Institute of Child HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ROUTINE DRUG - CONCENTRATION QLB

ALTERNATIVE DRUG - CONCENTRATION QLB

Arm Description

The patients will receive bilateral posterior quadratus lumborum block using 0.25% bupivacaine 0.4 ml/kg. in each side.

The patients will receive bilateral posterior quadratus lumborum block using 0.125% bupivacaine 0.4 ml/kg. in each side.

Outcomes

Primary Outcome Measures

Quality of postoperative analgesia
Postoperative pain score as CHEOPs SCORE

Secondary Outcome Measures

Incidence of complications
Intensity of motor block by using MODIFIED BROMAGE SCORE, vomiting and hemodynamic instability

Full Information

First Posted
July 9, 2021
Last Updated
August 1, 2021
Sponsor
Queen Sirikit National Institute of Child Health
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1. Study Identification

Unique Protocol Identification Number
NCT04998071
Brief Title
Posterior Quadratus Lumborum Block Using 0.125% Versus 0.25% Bupivacaine for Analgesia in Children Undergoing LPEC
Official Title
Comparison of Analgesic Efficiency in Laparoscopic Percutaneous Extraperitoneal Closure for Pediatric Inguinal Hernia and Hydrocele Provided by Ultrasound Guided Posterior Quadratus Lumborum Block Using Between 0.125% and 0.25% Bupivacaine
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2021 (Anticipated)
Primary Completion Date
May 31, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen Sirikit National Institute of Child Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the present study is to evaluate and compare the analgesic efficiency of the difference concentration between 0.125% and 0.25% bupivacaine provided by ultrasound guided posterior quadratus lumborum block undergoing LPEC in children
Detailed Description
Fifty participants both male and female aged from 1 to 6 years old, AGED FROM 1 TO 6 YEARS OLD, ASA class I to II undergoing elective Laparoscopic percutaneous extraperitoneal closure for pediatric inguinal hernia and hydrocele will be randomly divided into two equal groups of twenty five by using computer generated random table. All received premedication in the form of midazolam 0.1 mcg/kg IV. Perioperative monitoring included continuous ECG, NIBP and pulse oximetry. Baseline reading of these were recorded. General anesthesia will be inducted using thiopental 5 mg/kg then atracurium 0.5 mg/kg to facilitate endotracheal tube intubation and fentanyl 1 mcg/kg. Anesthesia will be maintained using 2% isoflurane with oxygen to air 40:60. Posterior quadratus lumborum block (The technique which local anesthetic agent is injected at middle thoracolumbar fascia between erector spina muscle and quadratus lumborum muscle) provided by GE, LOGIQe VERSION (12L-RS, LINEAR ARRAY) ultrasound guided and using stimuplex needle 22G-2 inches on both sides under sterile technique in lateral position will be performed in all patients immediately after induction and before starting surgery. patients will be allocated randomly into two equal groups, twenty five in each as the following GROUP 1 will receive 0.25% bupivacaine 0.4 ml/kg. per each side. GROUP 2 will receive 0.125% bupivacaine 0.4 ml/kg. per each side. The patients and parents along with independent anesthesiologist and attending nurses were not aware of group allocation. The surgical intervention was started not less than 10 minutes after block. Pneumoperitonium pressure was limited not exceed 10 mmHg. After completion of surgery, anesthesia was discontinued and muscle relaxant was reversed as usual. After extubation, the patients will be transfer to PACU. Postoperative pain will be assessed by attending nurses, using CHEOPs SCORE. Acetaminophen 10 mg/kg. orally will be given as rescue analgesia for patient with CHEOPs SCORE more than 6. Parameters will be assessed Intraoperative measurements: Hemodynamic parameters: HR and MAP were recorded before, immediately and every 5 minutes after induction of anesthesia until the end of the operation. Analgesic requirement: All through the procedure (By measure analgesic need intraoperative in the form of fentanyl 0.5 mcg/kg) In case of increase in intraoperative MAP or HR of more than 20% from baseline. Incidence of complications: In the form of hypotension, hematoma, intraabdominal organ injury LAST. Postoperative measurements: Quality of analgesia: Assessed immediately postoperatively every 30 minutes in the PACU and then at 4, 8, 12 hours at ward using CHEOPs SCORE and 24 hours postoperatively using PARENT'S POSTOPERATIVE PAIN MEASUREMENT(PPPM). Incidence of complications: In the form assessment of intensity of motor block by using MODIFIED BROMAGE SCORE, vomiting and hemodynamic instability. Others: In the form of parent's satisfaction of analgesia and length of hospital stay.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ROUTINE DRUG - CONCENTRATION QLB
Arm Type
Active Comparator
Arm Description
The patients will receive bilateral posterior quadratus lumborum block using 0.25% bupivacaine 0.4 ml/kg. in each side.
Arm Title
ALTERNATIVE DRUG - CONCENTRATION QLB
Arm Type
Active Comparator
Arm Description
The patients will receive bilateral posterior quadratus lumborum block using 0.125% bupivacaine 0.4 ml/kg. in each side.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine hydrochloride
Intervention Description
Analgesic efficiency comparison between two concentration of bupivacaine hydrochloride using for posterior quadratus lumborum block in LPEC
Primary Outcome Measure Information:
Title
Quality of postoperative analgesia
Description
Postoperative pain score as CHEOPs SCORE
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Incidence of complications
Description
Intensity of motor block by using MODIFIED BROMAGE SCORE, vomiting and hemodynamic instability
Time Frame
12 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children scheduled for laparoscopic percutaneous extraperitoneal closure(LPEC) for pediatric inguinal hernia and hydrocele ASA I-II physical status patients Complete inform consent for intervention Exclusion Criteria: Contraindication for regional anesthesia Sensitive to local anesthetic agent, opioid or acetaminophen Previous history of abdominal surgery History of neuromuscular disease G6PD deficiency
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SUWITCHA TAMRONGCHOTE, MD
Phone
+66989425629
Email
S.NI.KTAMP@GMAIL.COM
First Name & Middle Initial & Last Name or Official Title & Degree
NUTTAPHONG LEPANANON, MD
Phone
+66850602800
Email
N_PEDIAN@HOTMAIL.COM
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SUWITCHA TAMRONGCHOTE, MD
Organizational Affiliation
Queen Sirikit National Institute of Child Health (QSNICH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Sirikit National Institute of Child Health
City
Ratchathewi
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kullasate Sakpichaisakul, MD
Email
kullasate.s@rsu.ac.th
First Name & Middle Initial & Last Name & Degree
Kantapon Trongkamolchai, MD
Email
kantapon260619870@gmail.com
First Name & Middle Initial & Last Name & Degree
Kullasate Sakpichaisakul, MD
First Name & Middle Initial & Last Name & Degree
Kantapon Trongkamolchai, MD
First Name & Middle Initial & Last Name & Degree
Somjit Sri-udomkajorn, MD
First Name & Middle Initial & Last Name & Degree
Sirorat Suwannachote, MD
First Name & Middle Initial & Last Name & Degree
Ravivan Wittawassamrankul, R Ph
First Name & Middle Initial & Last Name & Degree
Ravindra Arya, MD, DM
First Name & Middle Initial & Last Name & Degree
Suwitcha Tamrongchote, MD

12. IPD Sharing Statement

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Posterior Quadratus Lumborum Block Using 0.125% Versus 0.25% Bupivacaine for Analgesia in Children Undergoing LPEC

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