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Completed

NCT Number: NCT06362811

Assessment of Efficacy of Sacral Erector Spinae Plane Block for Postoperative Analgesia in Pediatric Rectal Biopsies

The purpose of this study is to evaluate how sacral erector spinae block changed the postoperative analgesia requirements in pediatric patients undergoing rectal biopsies under general anesthesia.

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Key information

Conditions

Analgesia Acute Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Acute Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

1 day–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Cerrahpasa

Istanbul, 34098, Turkey (Türkiye)

About this study

Rectal biopsies in pediatric patients are performed under general anesthesia to obtain adequate tissue samples and optimize for patient comfort, well-being and safety. Post-operative pain can persist for longer than a day and requires analgesics. This study aimed to evaluate the effectiveness of sacral erector spinae block in decreasing post-operative pain scores and analgesic requirements.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing only rectal biopsy
  • ASA class I-II

Exclusion criteria

  • ASA class III or more
  • Coagulation disorders
  • Sacral or spinal anatomical abnormalities
  • Infection around the block site
  • Local anesthesia allergy

Treatment and study plan

Sacral Erector Spinae Plane Block

Procedure

Ultrasound-guided bilateral injection of 1ml/kg 0.25% bupivacaine into the plane underneath the erector spinae muscles over sacral crests. The needle is inserted with in-plane technique from cranial to caudal direction over S3-4.

Other names: Multifidus Plane Block

Primary outcomes

  1. Postoperative pain scores

    Time frame: Postoperative 30th minute, 1st hour, 2nd hour, 4th hour, 6th hour, 12th hour and 24th hour

    Children's and Infant's Postoperative Pain Scale (CHIPPS) assessment of postoperative pain (Scores between 0 and 3 indicate no pain, and scores above 4 indicate the need for pain management.)( minimum score is 0, maximum score is 10)

  2. Analgesia requirement

    Time frame: Post operative 24 hours

    If CHIPPS(Children's and Infant's Postoperative Pain Scale- minimum score is 0, maximum score is 10) score > 4, patient will receive 1mg/kg tramadol during the first post-operative hour. If CHIPPS score > 4 after 1st hour, patient will receive 10mg/kg paracetamol initially and if further assessment 30 min later is still >4 patient will receive additional 1mg/kg tramadol

Secondary outcomes

  1. Complications

    Time frame: Post-operative 24 hours

    Presence of nausea, vomiting, apnea, hypotension, bradycardia, urinary retention and other

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Assessment of Efficacy of Sacral Erector Spinae Plane Block for Postoperative Analgesia in Pediatric Rectal Biopsies: A Prospective Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2024
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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