NCT04921007

Brief Summary

This study will be conducted to evaluate efficacy of ultrasound guided sacral erector spinae plane block for postoperative analgesia in pediatric anorectal surgery in comparison to caudal block.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 13, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

July 7, 2022

Status Verified

July 1, 2022

Enrollment Period

11 months

First QC Date

June 3, 2021

Last Update Submit

July 5, 2022

Conditions

Analgesia

Keywords

Erector spinae plane blockUltrasound guidedSacralAnorectal surgery

Outcome Measures

Primary Outcomes (1)

  • Duration for the first analgesic request

    The time of the first analgesic request for paracetamol in minutes will be recorded.

    Up to 24 hours after the procedure

Secondary Outcomes (6)

  • Total analgesic requirements of paracetamol

    Up to 24 hours after the procedure

  • Improvement in pain scores

    Up to 24 hours after the procedure

  • Changes in heart rate

    Up to end of the surgery

  • Changes in mean arterial blood pressure

    Up to end of the surgery

  • Changes in postoperative emergence agitation scale

    Up to 30 minutes after the procedure

  • +1 more secondary outcomes

Study Arms (2)

Group (A) Sacral ESP block

ACTIVE COMPARATOR

Ultrasound guided sacral erector spinae plane (ESP) block will be performed in the lateral position under sterile conditions, and bupivacaine will be administered.

Procedure: Sacral ESP blockDrug: Bupivacaine Hydrochloride

Group (B) Caudal block

ACTIVE COMPARATOR

Ultrasound guided caudal block will be performed in the lateral position under sterile conditions, and bupivacaine will be administered.

Procedure: Caudal blockDrug: Bupivacaine Hydrochloride

Interventions

Sacral ESP blockPROCEDURE

A high-frequency ultrasound linear probe covered with a sterile sheath will be placed longitudinally to the midline of the sacrum. The median sacral crests and erector spinae muscle will be visualized, then a 22-gauge, 50 mm needle will be advanced from cranial to caudal direction until its tip touch the sacral crest.

Also known as: Ultrasound guided approach
Group (A) Sacral ESP block
Caudal blockPROCEDURE

A high-frequency ultrasound linear probe covered with a sterile sheath will be placed on to the sacrococcygeal region. The dura mater, epidural space, conus medullaris, sacral cornua, and sacrococcygeal ligament will be identified. Using the in-plane technique, a 22-gauge, 50 mm needle will be introduced to reach the sacral epidural space.

Also known as: Ultrasound guided approach
Group (B) Caudal block
Bupivacaine HydrochlorideDRUG

Following negative aspiration, a precalculated dose (0.5 ml/kg) of 0.25% bupivacaine will be injected.

Also known as: Marcaine
Group (A) Sacral ESP blockGroup (B) Caudal block

Eligibility Criteria

Age1 Year - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • American Society of Anesthesiology (ASA) I and II patients.
  • Scheduled for pediatric anorectal surgery

You may not qualify if:

  • Parental refusal of consent.
  • Children with developmental delays, mental or neurological disorders.
  • Bleeding or coagulation diathesis.
  • History of known sensitivity to the used anesthetics.
  • Infection or redness at the injection site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Sameh M El-Sherbiny, MD

    Mansoura Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of anesthesia, ICU & pain management; Faculty of Medicine

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 10, 2021

Study Start

August 13, 2021

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

July 7, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)