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Ultrasound Guided Pericapsular Nerve Group Block Versus Ultrasound Guided Caudal Block for Postoperative Pain in Paediatric Hip Surgery

Primary Purpose

Postoperative Pain in Paediatric Hip Surgery, PENG Block, Caudal Block

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound guided peng block in paediatric hip surgery
ultrasound guided caudal epidural block in paediatric hip surgery
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain in Paediatric Hip Surgery focused on measuring PENG block, caudal block, hip surgery, postoperative pain

Eligibility Criteria

2 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: paediatric patients belonging to American society of anesthesiologists (ASA)class1 or 2, aged 2-8 years scheduled for hip surgery Exclusion Criteria: parent refusal skin infection at site of injection bleeding disorder or receiving anticoagulants history of allergy or contraindicaion to local anaesthetics neurological disease as cerebral palsy

Sites / Locations

  • Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ultrasound guided peng block in paediatric hip surgery

ultrasound guided caudal epidural block in paediatric hip surgery

Arm Description

Patients will receive US-guided PENG block with 0.5 ml/kg of bupivacaine 0.25% after induction of general anaesthesia.

Patients will receive US-guided caudal block with 0.5 ml/kg of bupivacaine 0.25% after induction of general anaesthesia.

Outcomes

Primary Outcome Measures

postoperative opioid consumption
compare between both groups as regard postoperative opioid consumption

Secondary Outcome Measures

postoperative analgesia
postoperative analgesia by using FLACC scale
duration of postoperative analgesia
heamodynamics
changes in heart rate
incidence of complications
hypotension, bradycardia, nausea, vomiting, urinary retention, and pruritis
parent satisfaction
Using a 5 point score (0= very dissatisfied, 1= dissatisfied, 2= neither satisfied nor dissatisfied, 3= satisfied, 4= very satisfied)

Full Information

First Posted
July 10, 2023
Last Updated
July 30, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05981781
Brief Title
Ultrasound Guided Pericapsular Nerve Group Block Versus Ultrasound Guided Caudal Block for Postoperative Pain in Paediatric Hip Surgery
Official Title
Ultrasound Guided Pericapsular Nerve Group Block Versus Ultrasound Guided Caudal Block for Postoperative Pain in Paediatric Hip Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University

4. Oversight

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

5. Study Description

Brief Summary
Aim of the study is to evaluate postoperative analgesic effect of ultrasound guided PENG block in comparison to ultrasound guided caudal epidural anaesthesia for hip surgeries in paediatrics
Detailed Description
Hip surgeries in paediatric patients such as open hip surgery for correction of developmental dysplasia of the hip (DDH) lead to extensive injuries and severe pain. Multimodal analgesia is required to provide intraoperative and postoperative analgesia and to prevent the undesirable side effects of opioids including sedation, nausea, vomiting and constipation. Perioperative pain control is of paramount importance during paediatric hip surgery. Inadequate analgesia can contribute to patient and parental dissatisfaction, prolonged recovery, and increased length of hospital stay. As such, regional anaesthesia is advantageous in providing sufficient analgesia while reducing the adverse effects of opioids. The use of regional anaesthesia in the paediatric population has increased over the last decade as it offers several potential advantages in the provision of postoperative analgesia including a reduction in parenteral opioids, decreased exposure to general anaesthetic agents, and shortened hospital stay. Such techniques may be particularly valuable following painful orthopedic procedures including hip and femur surgery. Neuraxial techniques (caudal and intrathecal), lumbar plexus blockade, and combined femoral nerve and fascia iliaca blockade have been shown in a myriad of paediatric studies to exhibit opioid-sparing effects and lower postoperative pain scores in patients who are suffering from hip pain. Caudal block is a common technique used for perioperative pain relief in paediatric lower limb surgeries but despite the success of neuraxial blocks in decreasing postoperative pain scores in paediatric patients undergoing hip surgery, positioning requirements, bilateral sensory and motor blockade, and urinary retention limit their use. Among peripheral nerve block techniques used for relieving pain associated with hip fracture, ultrasound-guided femoral nerve (FN) block, fascia iliaca compartment (FIC) block and 3-in-1 FN block are widely used. However, these techniques have often failed to provide adequate block of the obturator nerve (ON) and the accessory obturator nerve (AON). The pericapsular nerve group (PENG) block is an ultrasound guided approach, first described by Girón-Arango et al.(11) in 2018 for the anaesthetizing the articular branches of the femoral, obturator and accessory obturator nerves that provide sensory innervation to the anterior hip capsule. It is a plane block involving one injection, performed under ultrasound guidance, of a high volume of local anaesthetic into the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. It was suggested that the articular branches of ON were blocked successfully due to the proximity of the target area to the subpectineal plane. PENG block has been initially used as an alternative regional anaesthetic technique for the management of acute pain after hip fracture , but its applications are expanding, suggesting a potential role for analgesia after elective hip surgery. Previous studies concluded that this technique could provide an effective blockade of the articular branches of FN, ON and AON, with a potential motor-sparing effect.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain in Paediatric Hip Surgery, PENG Block, Caudal Block
Keywords
PENG block, caudal block, hip surgery, postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blinded randomized study
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
the patients , outcome assessors and care providers are not informed with the block type done.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ultrasound guided peng block in paediatric hip surgery
Arm Type
Active Comparator
Arm Description
Patients will receive US-guided PENG block with 0.5 ml/kg of bupivacaine 0.25% after induction of general anaesthesia.
Arm Title
ultrasound guided caudal epidural block in paediatric hip surgery
Arm Type
Active Comparator
Arm Description
Patients will receive US-guided caudal block with 0.5 ml/kg of bupivacaine 0.25% after induction of general anaesthesia.
Intervention Type
Procedure
Intervention Name(s)
ultrasound guided peng block in paediatric hip surgery
Intervention Description
On the supine position, under strict aseptic technique, a linear, high-frequency transducer (5-13 MHz) of a Sonosite (M-Turbo; Sonosite Inc, Bothell, W, USA) portable US machine will be placed in the transverse plane along the anterior inferior iliac spine (AIIS) to identify the iliopsoas muscle, femoral artery, and femoral nerve. The probe will be then rotated, and aligned with the pubic ramus to visualize the AIIS, iliopubic eminence (IPE), femoral artery, psoas muscle, and the superior pubic ramus. Under direct visualization, a needle will be advanced in-plane, lateral to medial between the psoas tendon and pubic ramus until the needle contacts the IPE. The needle will be slightly withdrawn, and following negative aspiration, 0.5 ml/kg of bupivacaine 0.25% will be injected.
Intervention Type
Procedure
Intervention Name(s)
ultrasound guided caudal epidural block in paediatric hip surgery
Intervention Description
On lateral decubitus position, under strict aseptic technique, the sacral hiatus will be visualized at the level of the sacral cornua by employing a linear, high-frequency transducer (5-13 MHz) of a Sonosite (M-Turbo; Sonosite Inc, Bothell, W, USA) portable US machine will be placed transversely at the midline to obtain a transverse view of the two cornua, sacrococcygeal ligament, sacral bone, and sacral hiatus. At this level, the ultrasound transducer will be rotated to 90 degree to obtain longitudinal views of the sacrococcygeal ligament and sacral hiatus and subsequently placed between the two cornua. A needle will be advanced toward the upper third of the sacrococcygeal ligament. The needle advancement will be terminated immediately after penetrating the sacrococcygeal ligament. (17) At this level, after confirming absence of blood or cerebrospinal fluid on aspiration, bupivacaine 0.25% (0.5 mL/kg) will be injected over 1 minute while observing an ultrasound longitudinal image.
Primary Outcome Measure Information:
Title
postoperative opioid consumption
Description
compare between both groups as regard postoperative opioid consumption
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
postoperative analgesia
Description
postoperative analgesia by using FLACC scale
Time Frame
24 hours
Title
duration of postoperative analgesia
Time Frame
24 hours
Title
heamodynamics
Description
changes in heart rate
Time Frame
24 hours
Title
incidence of complications
Description
hypotension, bradycardia, nausea, vomiting, urinary retention, and pruritis
Time Frame
24 hours
Title
parent satisfaction
Description
Using a 5 point score (0= very dissatisfied, 1= dissatisfied, 2= neither satisfied nor dissatisfied, 3= satisfied, 4= very satisfied)
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
heamodynamics
Description
Changes in arterial blood pressure
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: paediatric patients belonging to American society of anesthesiologists (ASA)class1 or 2, aged 2-8 years scheduled for hip surgery Exclusion Criteria: parent refusal skin infection at site of injection bleeding disorder or receiving anticoagulants history of allergy or contraindicaion to local anaesthetics neurological disease as cerebral palsy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yomna Said, MBBCH
Phone
01065677956
Email
yomna.said7@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabab Saber, professor
Organizational Affiliation
Alexandria University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aly Mahmoud, lecturer
Organizational Affiliation
Alexandria University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed Mansour, professor
Organizational Affiliation
Alexandria University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
yomna Said, MBBCH
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Alexandria
State/Province
Alexandria, Egypt
ZIP/Postal Code
21111
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data results and statistical analysis
IPD Sharing Time Frame
before the start till publishing the study
IPD Sharing Access Criteria
not public only researchers who can access study information

Learn more about this trial

Ultrasound Guided Pericapsular Nerve Group Block Versus Ultrasound Guided Caudal Block for Postoperative Pain in Paediatric Hip Surgery

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