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

Not Applicable

Completed

• Conditions: Pain, Acute; Analgesia
• Interventions: Procedure: Sacral Erector Spinae Plane Block

• Registration Number: NCT06362811
• Lead Sponsor: Istanbul University

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.

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-04
• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-08
• Study First Posted: 2024-04-12
• Last Update Submitted: 2024-04-13
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General anesthesia + Sacral ESP block	Sacral Erector Spinae Plane Block	Patients will go under general anesthesia, receive only 1mcg/kg fentanyl and 10mg/kg paracetamol intraoperatively, and bilateral sacral ESP block

Primary Outcome Measures

Name	Time	Method
Analgesia requirement	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	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 Outcome Measures

Name	Time	Method
Complications	Post-operative 24 hours	Presence of nausea, vomiting, apnea, hypotension, bradycardia, urinary retention and other

Trial Locations

Locations (1)

Istanbul University Cerrahpasa; 🇹🇷 Istanbul, Turkey