NCT05695625

Brief Summary

Acute pain after cesarean section (SC) can be variable. Untreated pain can affect patients' life quality. Currently regional nerve blocks are frequently used as a part of multimodal analgesia. Erector spina plane block (ESPB), a recently defined interfacial plane block, provides multisegmental analgesia by spreading to both ventral and dorsal branches of the spinal nerve roots in the cranio-caudal plane with a single injection. The aim of this study is to evaluate the effects of ESPB on postoperative pain, analgesic use and patient satisfaction in patients delivered by CS under spinal anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

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

May 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2023

Completed
12 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

1.1 years

First QC Date

January 13, 2023

Last Update Submit

January 23, 2023

Conditions

Pain, Postoperative

Keywords

Erector spina plane blockpostoperative painobstetric analgesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    VAS scores at 2, 4, 6, 12 and 24th hours. (VAS is an 11 point numeric scale ranges from 0 to 10. )

    24 hours

Secondary Outcomes (6)

  • Postoperative analgesic drug consumption

    24 hours

  • Need for rescue analgesic

    24 hours

  • Number of patients with postoperative nausea-vomiting and need of antiemetic usage

    24 hours

  • Patients' satisfaction

    24 hours

  • First analgesic using time, first mobilization time, hospitalization time

    Postoperative 4 days on an average

  • +1 more secondary outcomes

Study Arms (2)

Group ESPB

ACTIVE COMPARATOR

Spinal anesthesia + bilateral ESPB (total of 40 ml, %0.5 bupivacaine)

Other: Spinal anesthesia + bilateral erector spine plane block

Group SA

ACTIVE COMPARATOR

Only spinal anesthesia

Other: Spinal anesthesia

Interventions

Spinal anesthesia + bilateral erector spine plane blockOTHER

Intraoperative period: Spinal anesthesia was administered with 0.5% bupivacaine and fentanyl 12.5mcg at the level of L4-5 interspace in the sitting position. At the end of the surgery, patients were given a sitting position with the help of 2 people for USG-guided ESPB. The high-frequency linear USG probe was placed in the midline at T12 level, after the spinous process visualized, the transverse process was visualized by moving probe 3-4cm laterally. After confirming the location of the needle tip with 1-2ml hydrodissection, 10 ml bupivacaine + 10 ml salin was applied both right and left sides. Postoperative period: If patients' VAS value \>4, 75mg diclofenac intramuscular was administered. After 30 mins if patients' VAS values \>4, 1000mg paracetamol intravenously was administered.

Group ESPB
Spinal anesthesiaOTHER

Intraoperative period: Spinal anesthesia was administered with 0.5% bupivacaine and fentanyl 12.5mcg at the level of L4-5 interspace in the sitting position. Postoperative period: If patients' VAS value \>4, 75mg diclofenac intramuscular was administered. After 30 mins if patients' VAS values \>4, 1000mg paracetamol intravenously was administered.

Group SA

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • between 18-45 years, pregnants delivered by CS from May 2020 to June 2021

You may not qualify if:

  • age under 18 years, over 45 years, body mass index (BMI) over 35 kg/m2, ASA status over III, multiple pregnancy, preeclampsia, bleeding diathesis, opioid use and allergy to drugs to be used in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bengi Şafak

Ankara, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Bengi Şafak

    Ankara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2023

First Posted

January 25, 2023

Study Start

May 1, 2020

Primary Completion

June 6, 2021

Study Completion

February 1, 2022

Last Updated

January 25, 2023

Record last verified: 2023-01

Locations

TU(1)