Clinical trial

Analgesic Effect of Fascia Transversalis Block Versus Transversus Abdominal Plane Block in Children Undergoing Open Inguinal Hernia Surgery. A Randomized Comparative Trial.

Name
MS-527-2023
Description
Fascia transversalis block in pediatrics undergoing inguinal surgical repair may be simple technique and may give longer effect in reduction of post-operative pain in comparison to transversus abdominis plane block.
Trial arms
Trial start
2024-01-18
Estimated PCD
2024-04-01
Trial end
2024-05-01
Status
Recruiting
Phase
Early phase I
Treatment
Ultrasound- guided Fascia Transversalis plane block
Ultrasound probe will be placed in a transverse orientation above the iliac crest; and the external oblique, internal oblique (IO), and transversus abdominis TA muscles will be identified and traced posteriorly until first the TA muscle and then the IO muscle tapered into their common aponeurosis, adjacent to the quadratus lumborum muscle. The tip of a 22-gauge 80-mm block needle will be positioned just deep to the TA muscle and its aponeurosis at the point where the TA is tapered off. 0.4 ml/kg bupivacaine 0.25% will be injected into the plane between the TA and underlying transversalis fascia
Arms:
Group A
Ultrasound-guided Transversus abdominus plane block
the probe will be placed transversely in the mid-axillary line between the iliac crest and the costal margin at the level of the umbilicus. The external oblique, internal oblique and transversus abdominis muscles and their fascias will be visualized. A 22 gauge, 80 mm needle will be introduced anteriorly and in the plane of the ultrasound probe, and on entering the plane between IO and TA, 2 ml of 0.9% saline will be injected to verify the correct position of the needle. Following negative aspiration, 0.4 ml/kg of bupivacaine 0.25% will be injected.
Arms:
Group B
Fentanyl
patients will receive an induction dose at 1 mcg/kg. If the analgesia was inadequate in the form of increase in heart rate and or arterial blood pressure by more than 20% of baseline values during surgery, this warrants the administration of intravenous fentanyl (0.5µg/kg).
Arms:
Group A, Group B
Pethidine
Pethidine IV will be given as rescue analgesia (0.5 mg/kg) if the FLACC pain score was more than 4 , the maximum allowed dose is 1mg/kg every 4 hours.
Arms:
Group A, Group B
Other names:
Rescue analgesia
Acetaminophen
patients will be given paracetamol (15 mg /kg/8 hrs ).
Arms:
Group A, Group B
Size
50
Primary endpoint
Time to First need of analgesia
First 6 hours postoperative
Eligibility criteria
Inclusion Criteria: * ASA physical status I-II Exclusion Criteria: * Parents' refusal to participate in the study. * Coagulopathy (i.e. Platelets ≤ 50,000 and/or INR\> 1.5). * Localized infection at the site of needle insertion. * Known hypersensitivity or allergies to any of the used drugs.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2024-03-22

1 organization

3 products

1 indication

Product
Fentanyl
Product
Pethidine