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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04373577
Other study ID # ESP block and PENG block
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2020
Est. completion date October 1, 2022

Study information

Verified date November 2022
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. Regional anesthetic techniques seem to be a better choice for improving acute pain management in these patients, with fewer adverse effects.


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. Regional anesthetic techniques seem to be a better choice for improving acute pain management in these patients, with fewer adverse effects. The erector spinae block is a recently described ultrasound-guided technique in which local anesthetics is injected into a fascial plane between the tips of the thoracic transverse processes and the overlying erector spinae muscle (longissimus thoracis). Pericapsular nerve group (PENG) block has been recently recommended by GirĂ³n-Arango et al. for use as postoperative analgesia in hip surgeries. It is a new regional anesthesia technique 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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date October 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender All
Age group 1 Year to 6 Years
Eligibility Inclusion Criteria: - Children of both genders - American Society of Anaestheologists (ASA) physical activity I, II - aged more than one year - admitted for elective pediatric hip surgery Exclusion Criteria: - Children with severe systemic disease with American Society of Anaestheologists (ASA) III or IV, - children with previous neurological or spinal disorders, - coagulation disorder, - infection at the block injection site, - history of allergy to local anesthetics - bilateral hip surgery.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
erector spinae plane block
the patient will be placed in the lateral position with the surgical side up for performing erector spinae plane block. After skin preparation, superficial (5-12 MHz) ultrasound transducer will be placed in a longitudinal orientation 1-2cm lateral to the midline at the sacral level. The L2 level will be identi?ed by counting upward from the sacrum. Following identi?cation of the erector spinae muscle (ESM) and transverse process, a 21 G needle will be inserted deep to the erector spinae muscle (ESM) in a cranio-caudal direction. After negative aspiration, the correct needle position will be con?rmed with the administration of 0.5-1ml LA. A total volume of 0.5 mL/kg local anesthetic solution will be injected interfascial plane between erector spinae muscle and transverse process for block performance.
pericapsular nerve group block
the patient will be 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 Time to first rescue analgesic demand Time to first rescue analgesic requirement: measured from the end of surgery till patient require analgesia. postoperative first day
Secondary Total doses of intraoperative fentanyl consumption Total doses of intraoperative fentanyl consumption intraoperative
Secondary Total analgesic consumption Total analgesic consumption If pain score more than 3, the child will be given intravenous morphine as rescue analgesia will be given in a dose 0.1mg/kg. postoperative first day
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