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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04336085
Other study ID # pericapsular nerve group block
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2020
Est. completion date April 30, 2024

Study information

Verified date April 2024
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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 GirĂ³n-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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 30, 2024
Est. primary completion date April 15, 2024
Accepts healthy volunteers No
Gender All
Age group 1 Year to 6 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
caudal block
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.
pericapsular nerve group block
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.

Locations

Country Name City State
Egypt Tarek Abdel Hay Tanta El Gharbyia

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total doses of postoperative analgesic requirement Total doses of postoperative morphine analgesic requirement postoperative first day
Secondary Evaluation of the pain scores Evaluation of the pain scores by FLACC scale postoperative first day
Secondary Time to first rescue analgesic demand after surgery postoperative first day