Analgesia for Perineal Surgeries in High-risk Pediatric Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Systemic analgesia, Sacral multifidus plane block.
- Who it may be relevant to
- Registry conditions: Analgesia. Basic parameters: 12 months — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Ultrasound-guided Sacral Multifidus Plane Block as Perioperative Analgesia for Anal and Penile Surgeries in High-risk Pediatric Patients
Overview
Perioperative pain management in pediatric patients, especially for anorectal and penile surgeries, presents significant challenges for anesthetists. Complications associated with systemic analgesia, such as respiratory issues, cardiovascular problems, and neurological effects, can be avoided by using regional anesthesia. This study aims to evaluate the effectiveness of Ultrasound-Guided Sacral Multifidus Plane Block as a method for perioperative analgesia in high-risk pediatric patients undergoing anorectal and penile surgeries, to reduce the risks associated with systemic analgesia.
Detailed description
Effective postoperative pain control in pediatric patients remains a major concern, particularly in those undergoing anal, perineal and penile surgeries. Inadequate analgesia is associated with delayed recovery, increased stress response, prolonged hospitalisation, and higher postoperative morbidity. This study aims to evaluate the efficacy of ultrasound-guided sacral multifidus plane block as a method for perioperative analgesia in high-risk pediatric patients undergoing anorectal and penile surgeries, to reduce the risks associated with systemic analgesia. This involves the administration of local anesthetics in the plane between the sacral multifidus muscle and the intermediate sacral crest bilaterally.
Interventions
- Other Systemic analgesia
Patients will receive 10 milligrams per kilogram body weight of intravenous paracetamol every 8 hours and fentanyl 1 microgram per kilogram body weight intravenously as rescue analgesia. - Procedure Sacral multifidus plane block
Patients will receive an ultrasound-guided sacral multifidus plane block after induction of general anesthesia.
Primary outcome measures
- Time to rescue analgesia [Time frame: 24 hours]
Secondary outcome measures (5)
- Heart rate [Time frame: 24 hours]
- Mean arterial pressure [Time frame: 24 hours]
- Postoperative pain score [Time frame: 24 hours]
- Total dose of opioid consumption [Time frame: 24 hours]
- Parental satisfaction [Time frame: 24 hours]
Eligibility criteria
Inclusion criteria
- Parents or caregivers' acceptance.
- High-risk pediatric patients (the American Society of Anesthesiologists physical status class III-IV)
- Body mass index equal to 5%: 85% of the same age and sex.
Exclusion criteria
- Child with a contraindication to the regional block, such as infection at the site of injection, or coagulopathy.
- Pre-existing neurological disorders.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Mistry T, Sonawane K, Balasubramanian S, Balavenkatasubramanian J, Goel VK. Ultrasound-guided sacral multifidus plane block for sacral spine surgery: A case report. Saudi J Anaesth. 2022 Apr-Jun;16(2):236-239. doi: 10.4103/sja.sja_723_21. Epub 2022 Mar 17. PMID 35431750
- Stamer UM, Bernhart K, Lehmann T, Setzer M, Stuber F, Komann M, Meissner W. 'Desire for more analgesic treatment': pain and patient-reported outcome after paediatric tonsillectomy and appendectomy. Br J Anaesth. 2021 Jun;126(6):1182-1191. doi: 10.1016/j.bja.2020.12.047. Epub 2021 Mar 5. PMID 33685632
Identifiers
NCT: NCT07602894 · High risk pediatric analgesia