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Clinical Trials/NCT06362811
NCT06362811
Completed
Not Applicable

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

Istanbul University1 site in 1 country48 target enrollmentJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Analgesia
Sponsor
Istanbul University
Enrollment
48
Locations
1
Primary Endpoint
Analgesia requirement
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
December 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

pinar kendigelen

Associate Professor

Istanbul University - Cerrahpasa (IUC)

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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)

Secondary Outcomes

  • Complications(Post-operative 24 hours)

Study Sites (1)

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