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

April 13, 2024 updated by: pinar kendigelen, Istanbul University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34098
        • Istanbul University Cerrahpasa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: General anesthesia
Patients will go under general anesthesia and receive only 1mcg/kg fentanyl and 10mg/kg paracetamol as analgesia intraoperatively
Active Comparator: General anesthesia + Sacral ESP block
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
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.
Other Names:
  • Multifidus Plane Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Postoperative 30th minute, 1st hour, 2nd hour, 4th hour, 6th hour, 12th hour and 24th hour
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
Post operative 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: Post-operative 24 hours
Presence of nausea, vomiting, apnea, hypotension, bradycardia, urinary retention and other
Post-operative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Study Director: Ayse C Tutuncu, MD, Istanbul University - Cerrahpasa (IUC)
  • Principal Investigator: Pinar Kendigelen, MD, Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 13, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 483730

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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