Ultrasound Guided Pericapsular Nerve Group Block Versus Ultrasound Guided Caudal Block for Postoperative Pain in Paediatric Hip Surgery

Caudal Block Clinical Trial

Official title:

Ultrasound Guided Pericapsular Nerve Group Block Versus Ultrasound Guided Caudal Block for Postoperative Pain in Paediatric Hip Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05981781
• Other study ID #: 0107623
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2023
• Source: Alexandria University
• Contact: Yomna Said, MBBCH
• Phone: 01065677956
• Email: yomna.said7[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim of the study is to evaluate postoperative analgesic effect of ultrasound guided PENG block in comparison to ultrasound guided caudal epidural anaesthesia for hip surgeries in paediatrics

Description:

Hip surgeries in paediatric patients such as open hip surgery for correction of developmental dysplasia of the hip (DDH) lead to extensive injuries and severe pain. Multimodal analgesia is required to provide intraoperative and postoperative analgesia and to prevent the undesirable side effects of opioids including sedation, nausea, vomiting and constipation. Perioperative pain control is of paramount importance during paediatric hip surgery. Inadequate analgesia can contribute to patient and parental dissatisfaction, prolonged recovery, and increased length of hospital stay. As such, regional anaesthesia is advantageous in providing sufficient analgesia while reducing the adverse effects of opioids. The use of regional anaesthesia in the paediatric population has increased over the last decade as it offers several potential advantages in the provision of postoperative analgesia including a reduction in parenteral opioids, decreased exposure to general anaesthetic agents, and shortened hospital stay. Such techniques may be particularly valuable following painful orthopedic procedures including hip and femur surgery. Neuraxial techniques (caudal and intrathecal), lumbar plexus blockade, and combined femoral nerve and fascia iliaca blockade have been shown in a myriad of paediatric studies to exhibit opioid-sparing effects and lower postoperative pain scores in patients who are suffering from hip pain. Caudal block is a common technique used for perioperative pain relief in paediatric lower limb surgeries but despite the success of neuraxial blocks in decreasing postoperative pain scores in paediatric patients undergoing hip surgery, positioning requirements, bilateral sensory and motor blockade, and urinary retention limit their use. Among peripheral nerve block techniques used for relieving pain associated with hip fracture, ultrasound-guided femoral nerve (FN) block, fascia iliaca compartment (FIC) block and 3-in-1 FN block are widely used. However, these techniques have often failed to provide adequate block of the obturator nerve (ON) and the accessory obturator nerve (AON). The pericapsular nerve group (PENG) block is an ultrasound guided approach, first described by Girón-Arango et al.(11) in 2018 for the anaesthetizing the articular branches of the femoral, obturator and accessory obturator nerves that provide sensory innervation to the anterior hip capsule. It is a plane block involving one injection, performed under ultrasound guidance, of a high volume of local anaesthetic into the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. It was suggested that the articular branches of ON were blocked successfully due to the proximity of the target area to the subpectineal plane. PENG block has been initially used as an alternative regional anaesthetic technique for the management of acute pain after hip fracture , but its applications are expanding, suggesting a potential role for analgesia after elective hip surgery. Previous studies concluded that this technique could provide an effective blockade of the articular branches of FN, ON and AON, with a potential motor-sparing effect.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 8 Years

Eligibility

Inclusion Criteria:

• paediatric patients belonging to American society of anesthesiologists (ASA)class1 or 2, aged 2-8 years scheduled for hip surgery

Exclusion Criteria:

• parent refusal skin infection at site of injection bleeding disorder or receiving anticoagulants history of allergy or contraindicaion to local anaesthetics neurological disease as cerebral palsy

Related Conditions & MeSH terms

• Caudal Block
• Pain, Postoperative

Intervention

Procedure:
• ultrasound guided peng block in paediatric hip surgery
On the supine position, under strict aseptic technique, a linear, high-frequency transducer (5-13 MHz) of a Sonosite (M-Turbo; Sonosite Inc, Bothell, W, USA) portable US machine will be placed in the transverse plane along the anterior inferior iliac spine (AIIS) to identify the iliopsoas muscle, femoral artery, and femoral nerve. The probe will be then rotated, and aligned with the pubic ramus to visualize the AIIS, iliopubic eminence (IPE), femoral artery, psoas muscle, and the superior pubic ramus. Under direct visualization, a needle will be advanced in-plane, lateral to medial between the psoas tendon and pubic ramus until the needle contacts the IPE. The needle will be slightly withdrawn, and following negative aspiration, 0.5 ml/kg of bupivacaine 0.25% will be injected.
• ultrasound guided caudal epidural block in paediatric hip surgery
On lateral decubitus position, under strict aseptic technique, the sacral hiatus will be visualized at the level of the sacral cornua by employing a linear, high-frequency transducer (5-13 MHz) of a Sonosite (M-Turbo; Sonosite Inc, Bothell, W, USA) portable US machine will be placed transversely at the midline to obtain a transverse view of the two cornua, sacrococcygeal ligament, sacral bone, and sacral hiatus. At this level, the ultrasound transducer will be rotated to 90 degree to obtain longitudinal views of the sacrococcygeal ligament and sacral hiatus and subsequently placed between the two cornua. A needle will be advanced toward the upper third of the sacrococcygeal ligament. The needle advancement will be terminated immediately after penetrating the sacrococcygeal ligament. (17) At this level, after confirming absence of blood or cerebrospinal fluid on aspiration, bupivacaine 0.25% (0.5 mL/kg) will be injected over 1 minute while observing an ultrasound longitudinal image.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Alexandria	Alexandria, Egypt

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	heamodynamics	Changes in arterial blood pressure	24 hours
Primary	postoperative opioid consumption	compare between both groups as regard postoperative opioid consumption	24 hours
Secondary	postoperative analgesia	postoperative analgesia by using FLACC scale	24 hours
Secondary	duration of postoperative analgesia		24 hours
Secondary	heamodynamics	changes in heart rate	24 hours
Secondary	incidence of complications	hypotension, bradycardia, nausea, vomiting, urinary retention, and pruritis	24 hours
Secondary	parent satisfaction	Using a 5 point score (0= very dissatisfied, 1= dissatisfied, 2= neither satisfied nor dissatisfied, 3= satisfied, 4= very satisfied)	24 hours