Clinical trial NCT06563622: Pericapsular Nerve Group Block Versus Caudal Block for Postoperative Pain Management in Pediatric Hip Surgery
Official title: Ultrasound-Guided Pericapsular Nerve Group Block Versus Ultrasound-Guided Caudal Block for Postoperative Pain Management in Pediatric Hip Surgery; a Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children can experience substantial pain after hip operations, causing agitation, depression, and sleep disruption, which can have a negative impact on their health. Opioids are associated with several serious side effects that limits its use as solo agents for pain management. Regional blocks such as caudal Block (CB) and pericapsular nerve group (PENG) block in adjuvant with general anaesthesia are alternative perioperative analgesic techniques that lead to lesser side effects, including motor weakness, postoperative nausea and vomiting with decreased opioid consumption.

Detailed description: Regional anesthesia is often used to prevent postoperative pain in pediatric surgery. Combined with general anesthesia (GA), ultrasound (US)-guided regional anesthetic approaches provide simple intraoperative pathway that reduced GA requirements, lower pain score with less impact on the respiratory or cardiovascular system

In pediatric surgery, caudal block (CB) is a low-cost, simple, and effective procedure for postoperative analgesia. CB is suggested for most surgeries in the lower body, primarily below the umbilicus. Although the well-established anesthetic properties of CB, its action terminates early in the postoperative period and it has a number of restrictions, such as anatomical abnormalities or infection at the injection site, that can prevent its use

PENG block is the plane lying between the psoas muscle and tendon and the ilio-pubic eminence. The single-shot PENG block has lately been reported in the cadaveric study and in the literature for perioperative pain management in hip surgery by aiming the articular arms of the accessory obturator nerve (AON), femoral nerve (FN), and obturator nerve (ON). The technical simplicity of imaging in traction-fixed patients and no need for multiple punctures made this blockage ideal for young pediatric patients. Unfortunately, there are no adequate studies regarding PENG block in patients younger than five years old.

This study was carried out to assess ultrasound-guided PENG block versus CB for their efficacy, safety and pain management in pediatric hip surgery.

Eligibility criteria: Inclusion Criteria:

* child aged 1- 7 years old
* American Society of Anesthesiologists (ASA) physical status I-II
* scheduled for elective hip surgery under general anesthesia

Exclusion Criteria:

* parents/guardians refusal to participate
* known local anesthetic drug sensitivity,
* bleeding disorders,
* pre-existing infection at the block site, and
* the presence of major cardiac, renal, or hepatic disorders.

Primary outcomes:
measure: pain score with FLACC
timeFrame: 30 minutes postoperative, 1 hour postoperative, 2 hour postoperative, and 6 hours postoperative
Secondary outcomes:
measure: The duration of the block
timeFrame: immediately after the intervention, up to 24 hours postoperative
measure: the Time to first postoperative rescue analgesia
timeFrame: 24 hours postoperative
measure: Total rescue analgesia consumption
timeFrame: 24 hours postoperative
measure: The incidence of postoperative adverse effects
timeFrame: 24 hours postoperative
measure: Parents satisfaction score
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Samar Rafik Mohamed Amin
state: Qalubia
Study officials:
References: