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

NCT06362811 | Completed

• 1 other identifier: 483730
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia; Pain, Acute

Keywords

Rectal Biopsy; Sacral Erector Spinae Block

Outcome Measures

Primary Outcomes (2)

• Postoperative pain scores

  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)

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

• Analgesia requirement

  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

  Post operative 24 hours

Secondary Outcomes (1)

• Complications

  Post-operative 24 hours

Study Arms (2)

General anesthesia

NO INTERVENTION

Patients will go under general anesthesia and receive only 1mcg/kg fentanyl and 10mg/kg paracetamol as analgesia intraoperatively

General anesthesia + Sacral ESP block

ACTIVE COMPARATOR

Patients will go under general anesthesia, receive only 1mcg/kg fentanyl and 10mg/kg paracetamol intraoperatively, and bilateral sacral ESP block

Procedure: Sacral Erector Spinae Plane Block

Interventions

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.

Also known as: Multifidus Plane Block

General anesthesia + Sacral ESP block

Eligibility Criteria

• Age: 1 Day - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Cerrahpasa

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (3)

• Piraccini E, Taddei S. Sacral multifidus plane block: The correct name for sacral erector spinae plane block. J Clin Anesth. 2020 Aug;63:109754. doi: 10.1016/j.jclinane.2020.109754. Epub 2020 Feb 28. No abstract available.

  PMID: 32120194 BACKGROUND

• Tulgar S, Senturk O, Thomas DT, Deveci U, Ozer Z. A new technique for sensory blockage of posterior branches of sacral nerves: Ultrasound guided sacral erector spinae plane block. J Clin Anesth. 2019 Nov;57:129-130. doi: 10.1016/j.jclinane.2019.04.014. Epub 2019 Apr 15. No abstract available.

  PMID: 30999197 BACKGROUND

• Oksuz G, Arslan M, Bilal B, Gisi G, Yavuz C. Ultrasound guided sacral erector spinae block for postoperative analgesia in pediatric anoplasty surgeries. J Clin Anesth. 2020 Mar;60:88. doi: 10.1016/j.jclinane.2019.08.006. Epub 2019 Sep 3. No abstract available.

  PMID: 31491727 BACKGROUND

MeSH Terms

Conditions

Agnosia; Acute Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Study Officials

• Ayse C Tutuncu, MD

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

• Pinar Kendigelen, MD

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 12, 2024
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)