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Comparison of Ultrasound Guided Caudal Block and Ultrasound Guided Pericapsular Nerve Group Block for Pediatric Hip Surgery

Primary Purpose

Post Operative Pain After Pediatric Hip Surgery

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
caudal block
pericapsular nerve group block
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post Operative Pain After Pediatric Hip Surgery

Eligibility Criteria

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

Inclusion Criteria:

  • 1- American Society of Anaestheologists physical activity class I and II. 2-aged between 1 year to 6 years. 3- undergoing pediatric elective hip surgery.

Exclusion Criteria:

  • 1-Children with severe systemic disease with American Society of Anaestheologists physical activity class III or IV.

    2-children with previous neurological or spinal disorders. 3-coagulation disorder. 4-infection at the block injection site. 5-history of allergy to local anesthetics. 6-bilateral hip surgery.

Sites / Locations

  • Tarek Abdel Hay

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

caudal group

PENG group

Arm Description

Caudal block using ultrasound guidance. the sacral hiatus will be visualized at the level of the sacral cornus by employing the linear transducer of ultrasound machine and the depth and gain will be adjusted for optimal visual quality.the needle will be advanced toward the upper third of the sacrococcygeal ligament. The needle advancement will be terminated immediately after penetrating the sacrococcygeal ligament.

The ilio-pubic eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be visualized using a linear ultrasound probe. the needle will be introduced in a lateral to medial fashion in an in-plane approach to place the tip of the needle in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly.

Outcomes

Primary Outcome Measures

Total doses of postoperative analgesic requirement
Total doses of postoperative morphine analgesic requirement

Secondary Outcome Measures

Evaluation of the pain scores
Evaluation of the pain scores by FLACC scale
Time to first rescue analgesic demand after surgery

Full Information

First Posted
April 3, 2020
Last Updated
June 1, 2020
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT04336085
Brief Title
Comparison of Ultrasound Guided Caudal Block and Ultrasound Guided Pericapsular Nerve Group Block for Pediatric Hip Surgery
Official Title
Comparison of Ultrasound Guided Caudal Block and Ultrasound Guided Pericapsular Nerve Group Block for Pediatric Hip Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
May 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

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
Surgical repair of the hip can be extremely painful and is associated with considerable postoperative pain in children despite the use of systemic opioids. These patients may benefit from neuraxial analgesia in adjunction with general anesthesia. The reported advantages of this technique include decreased opiate exposure, decreased time in the post-anesthesia recovery room, decreased hospital stay, reduce the post-operative morbidity, provide early mobilization. Ultrasound guided caudal block has many advantages as it is helpful for visualization of the sacral hiatus, sacrococcygeal ligament, epidural space and the distribution of the local anesthetic agent within the epidural space. So, the success rate of caudal block is increase . Pericapsular nerve group (PENG) block has been recently recommended by Girón-Arango et al. for use as postoperative analgesia in hip surgeries (8) It is a new regional anesthesia method in the region between the anterior inferior iliac spine (AIIS) and ilio-pubic eminence
Detailed Description
Surgical repair of the hip can be extremely painful and is associated with considerable postoperative pain in children despite the use of systemic opioids. These patients may benefit from neuraxial analgesia in adjunction with general anesthesia. The reported advantages of this technique include decreased opiate exposure, decreased time in the post-anesthesia recovery room, decreased hospital stay, reduce the post-operative morbidity, provide early mobilization. (1,2) Single shot caudal block has been the widely used to provide intraoperative and postoperative analgesia especially in pediatric surgery below the umbilical level, by block the region between T10 and S5 dermatomes. (3,4) The success rate of classic caudal epidural anesthesia method in pediatric patients has been reported to be about 75%. (5) Because there are many anatomical variations have been reported for sacral hiatus and sacral cornua. Ultrasound guided caudal block has many advantages as it is helpful for visualization of the sacral hiatus, sacrococcygeal ligament, epidural space and the distribution of the local anesthetic agent within the epidural space. So, the success rate of caudal block is increase (6) However caudal block has adverse effects such as hypotension, postoperative nausea, vomiting, urinary retention, excessive motor block, and pruritus that limit the use of caudal block in children. (7) Regional anesthetic techniques seem to be a better choice for improving acute pain management in these patients, with fewer adverse effects. Pericapsular nerve group (PENG) block has been recently recommended by Girón-Arango et al. for use as postoperative analgesia in hip surgeries (8) It is a new regional anesthesia method in the region between the anterior inferior iliac spine (AIIS) and ilio-pubic eminence (IPE). The anterior capsule is the most richly innervated section of the joint suggesting these nerves should be the main targets for hip analgesia. (9) To the best of our knowledge, there are no previously published data comparing the pericapsular nerve group (PENG) block with caudal block techniques.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain After Pediatric Hip Surgery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
caudal group
Arm Type
Experimental
Arm Description
Caudal block using ultrasound guidance. the sacral hiatus will be visualized at the level of the sacral cornus by employing the linear transducer of ultrasound machine and the depth and gain will be adjusted for optimal visual quality.the needle will be advanced toward the upper third of the sacrococcygeal ligament. The needle advancement will be terminated immediately after penetrating the sacrococcygeal ligament.
Arm Title
PENG group
Arm Type
Experimental
Arm Description
The ilio-pubic eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be visualized using a linear ultrasound probe. the needle will be introduced in a lateral to medial fashion in an in-plane approach to place the tip of the needle in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly.
Intervention Type
Procedure
Intervention Name(s)
caudal block
Intervention Description
Caudal block will be performed using ultrasound guidance, the sacral hiatus will be visualized at the level of the sacral cornus by employing the linear transducer of ultrasound machine the ultrasound transducer will be rotated to 90 degree to obtain longitudinal views of the sacrococcygeal ligament and sacral hiatus and will be subsequently placed between the two cornua. The needle advancement will be terminated immediately after penetrating the sacrococcygeal ligament.
Intervention Type
Procedure
Intervention Name(s)
pericapsular nerve group block
Intervention Description
In PENG group, the patient will be placed in supine position. The ilio-pubic eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be visualized using a linear ultrasound probe. A 22-gauge, 50-mm needle will be introduced in a lateral to medial fashion in an in-plane approach to place the tip of the needle in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, a total volume of 0.5 mL/kg local anesthetic solution will be injected.
Primary Outcome Measure Information:
Title
Total doses of postoperative analgesic requirement
Description
Total doses of postoperative morphine analgesic requirement
Time Frame
postoperative first day
Secondary Outcome Measure Information:
Title
Evaluation of the pain scores
Description
Evaluation of the pain scores by FLACC scale
Time Frame
postoperative first day
Title
Time to first rescue analgesic demand after surgery
Time Frame
postoperative first day

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: 1- American Society of Anaestheologists physical activity class I and II. 2-aged between 1 year to 6 years. 3- undergoing pediatric elective hip surgery. Exclusion Criteria: 1-Children with severe systemic disease with American Society of Anaestheologists physical activity class III or IV. 2-children with previous neurological or spinal disorders. 3-coagulation disorder. 4-infection at the block injection site. 5-history of allergy to local anesthetics. 6-bilateral hip surgery.
Facility Information:
Facility Name
Tarek Abdel Hay
City
Tanta
State/Province
El Gharbyia
ZIP/Postal Code
31527
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Ultrasound Guided Caudal Block and Ultrasound Guided Pericapsular Nerve Group Block for Pediatric Hip Surgery

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