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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06362811
Enrollment
48
Registered
2024-04-12
Start date
2023-01-01
Completion date
2023-12-31
Last updated
2024-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Pain, Acute

Keywords

Rectal Biopsy, Sacral Erector Spinae Block

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.

Interventions

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.

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Days to 5 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain scoresPostoperative 30th minute, 1st hour, 2nd hour, 4th hour, 6th hour, 12th hour and 24th hourChildren'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)
Analgesia requirementPost operative 24 hoursIf 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

MeasureTime frameDescription
ComplicationsPost-operative 24 hoursPresence of nausea, vomiting, apnea, hypotension, bradycardia, urinary retention and other

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026