NCT05697315

Brief Summary

Erector spinae plane (ESP) block is an interfacial plane block with visceral and somatic analgesic activity at paraspinal muscles. This study aims to examine the postoperative analgesic efficacy of ESP block after cesarean section (CS) with Pfannenstiel incision under spinal anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable pain

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

Study Start

First participant enrolled

December 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

January 4, 2023

Last Update Submit

January 16, 2023

Conditions

PainPost Operative Pain

Keywords

Painpostoperative analgesiaErector spinae plane blockcesarean section

Outcome Measures

Primary Outcomes (1)

  • 24-hour opioid consumption

    The amount of tramadol consumed in milligrams in the first 24 hours was determined with a patient-controlled analgesia pump.

    up to 24 hour

Secondary Outcomes (1)

  • Visual Analog Scale (Vas)

    0, 30 minutes, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours

Study Arms (2)

Control group

SHAM COMPARATOR

No block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.

Procedure: Control

Erector spinae plane block

ACTIVE COMPARATOR

Erector spinae plane block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.

Procedure: Erector spinae plane block

Interventions

ControlPROCEDURE

No block was performed

Control group
Erector spinae plane blockPROCEDURE

Erector spinae plane block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.

Erector spinae plane block

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASA II patients
  • years who underwent CS with Pfannenstiel incision under spinal anesthesia
  • agreed to participate in the study

You may not qualify if:

  • Patients with infection at the injection site
  • Coagulopathy Allergy to amide-type local anesthetics
  • History of peripheral neuropathy
  • Hepatic and/or renal failure
  • Refusing the procedure
  • patients with heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaras Sutcu Imam University

Kahramanmaraş, 46100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainPain, Postoperative

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Gökçe Gişi

    Kahramanmaras Sutcu Imam University Hospital Kahramanmaras, Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double (Investigator, Outcomes Assessor)
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 4, 2023

First Posted

January 25, 2023

Study Start

December 1, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

January 25, 2023

Record last verified: 2023-01

Locations

TU(1)