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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06362811
• Other study ID #: 483730
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2024
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Analgesia
• Pain, Acute

Intervention

Procedure:
• Sacral Erector Spinae Plane Block
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.

Locations

Country	Name	City	State
Turkey	Istanbul University Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Complications	Presence of nausea, vomiting, apnea, hypotension, bradycardia, urinary retention and other	Post-operative 24 hours