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

June 1, 2020 updated by: tarek abdel hay mostafa, Tanta University

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

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • El Gharbyia
      • Tanta, El Gharbyia, Egypt, 31527
        • Tarek Abdel Hay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: caudal group
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.
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.
EXPERIMENTAL: PENG group
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total doses of postoperative analgesic requirement
Time Frame: postoperative first day
Total doses of postoperative morphine analgesic requirement
postoperative first day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the pain scores
Time Frame: postoperative first day
Evaluation of the pain scores by FLACC scale
postoperative first day
Time to first rescue analgesic demand after surgery
Time Frame: postoperative first day
postoperative first day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 15, 2020

Primary Completion (ANTICIPATED)

April 1, 2021

Study Completion (ANTICIPATED)

May 31, 2021

Study Registration Dates

First Submitted

April 3, 2020

First Submitted That Met QC Criteria

April 3, 2020

First Posted (ACTUAL)

April 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 1, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • pericapsular nerve group block

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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