An interventional study of FTPB and PENG Block in Pain, Postoperative, Developmental Dysplasia of the Hip and Regional Anesthesia Morbidity, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 1 Year to 6 Years. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Alexandria University · Not applicable, Interventional, and Prevention
Hip joint surgery for developmental dysplasia of the hip (DDH) in children is extremely painful and associated with considerable postoperative pain despite the use of systemic opioids. Caudal anesthesia and lumbar plexus block (LPB) were still the most common regional anesthesia techniques for perioperative analgesia in children undergoing this type of surgery. recently, pediatric anesthesiologists don't consider choosing both techniques because of potential complications such as intravascular and intrathecal injection, and urine retention. novel peripheral nerve blocks have been advocated in pediatrics to avoid the aforementioned complications such as PEricapsular Nerve Group (PENG) block, Quadratus Lumborum Block (QLB), and Fascia Transversalis Plane Block (FTPB) The objective of the current study is to assess the analgesic efficacy of ultrasound-guided FTPB versus ultrasound-guided PENG block in pediatric patients undergoing open hip surgery for DDH
During the pre-anesthesia check-up visit, the proposed intervention will be discussed with the eligible participant's parents or caregivers including data about the aim, the advantages, and the expected side effects, and then a detailed written informed consent will be obtained before recruitment and randomization.
All participants will be premedicated with 0.5mg/kg oral midazolam about 30min before being admitted to the operating room. The routine standard monitoring including electrocardiography (ECG), non-invasive blood pressure (NIBP), pulse oximetry for blood oxygen saturation (SpO2), temperature probe, and end-tidal CO2 (EtCO2) will be applied to all participants. Induction of general anesthesia (GA) will be performed using a face mask with sevoflurane inhalation in oxygen starting with 2% up to 8% till complete loss of consciousness after that peripheral intravenous (IV) line will be secured where fentanyl 1 μg/kg and followed by cisatracurium 0.15mg/kg to facilitate orotracheal intubation. Anesthesia will be maintained by using isoflurane 1.2-1.5% in oxygen air mixture 50%:50% in addition to incremental cisatracurium 0.03mg/kg.
After induction of GA, the eligible participants will be randomly assigned to one of two equal groups either FTPB or PENG block.
In both interventional group participants, the assigned block will be performed after induction of GA by the same investigator who will have no further role in the study. Surgery will be started about 15 minutes after performing the block.
Fentanyl 1μg/ kg will be administrated intraoperatively in the case of inadequate analgesia which is defined as an increase of heart rate (HR) and/or mean arterial blood pressure (MAP) more than 20% above the pre-operative values. At the end of the surgery, isoflurane will be switched off and extubation will be done after reversal of muscle relaxant with neostigmine 0.05 mg/kg and atropine 0.02 mg/kg where the participants will be transferred to the Post-Anesthesia Care Unit (PACU). Paracetamol (15 mg/kg) will be administered IV every 6 hours in all participants.
114 studies on the registry are indexed under Developmental Dysplasia of the Hip; 17 are open to participants now.
This study's enrollment of 60 is close to the median of 61 across 71 interventional studies indexed under Developmental Dysplasia of the Hip.
Browse Developmental Dysplasia of the Hip studies →Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
The TFPB will be performed while the participant is in the supine position. a high-frequency linear ultrasound probe (5-13 MHz) will be placed transversely in the midaxillary line between the iliac crest and the costal margin. After the external oblique, internal oblique, transversus abdominis muscle, and quadratus lumborum (QL) muscle will be identified.
Procedure: FTPB
while the participant is in the supine position, a linear ultrasound probe will be initially placed in a transverse plane over the anterior inferior iliac spine (AIIS) and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees; In this view, the ilio-pubic eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be observed.
Procedure: PENG Block
A 22-gauge needle will be advanced from anterior using an in-plane technique and passed through the posterior 'tail' of the transversus muscle. the local anesthetic solution of 0.25% bupivacaine will be injected for a total volume of 0.5 ml/kg will be injected to separate the transversalis fascia from the transversus muscle.
Also known as: Fascia Transversalis Plane Block
A 22-gauge, 80-mm needle will be inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly where the local anesthetic solution of 0.25% bupivacaine will be injected for a total volume of 0.5 ml/kg
Also known as: Pericapsular Nerve Group block
The time until the first rescue analgesic requirement postoperatively
Postoperative pain will be assessed by Face, leg, activity, cry, consolability (FLACC) score by the attending physician either in the PACU or in the surgical ward which ranges from a minimum score of zero (relaxed \& comfortable) to a maximum of 10 (severe discomfort \&pain). Morphine IV 0.1 mg/kg will be given as rescue analgesia if the FLACC score will be more than 3.
Time frame: the first postoperative 48 hours
Plan to share: No
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Developmental Dysplasia of the Hip→
Alexandria University