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

NCT ID: NCT06362811

Last Updated: 2024-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Analgesia Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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General anesthesia

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type ACTIVE_COMPARATOR

Sacral Erector Spinae Plane Block

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Multifidus Plane Block

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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pinar kendigelen

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayse C Tutuncu, MD

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Pinar Kendigelen, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Locations

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Istanbul University Cerrahpasa

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 32120194 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30999197 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31491727 (View on PubMed)

Other Identifiers

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483730

Identifier Type: -

Identifier Source: org_study_id

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