NCT03460093

Brief Summary

PURPOSE: to evaluate the efficacy of superior hypogastric plexus block for pain relief after cesarean section

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 all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

March 15, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2019

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

February 27, 2018

Last Update Submit

March 18, 2019

Conditions

Superior Hypogastric Plexus Block

Keywords

nerve blockadehypogastric plexuscesarean section

Outcome Measures

Primary Outcomes (5)

  • postoperative pain score

    postoperative pain score evaluated with Visual Analog Scale

    postoperative 1. hour

  • postoperative pain score

    postoperative pain score evaluated with Visual Analog Scale

    postoperative 6. hour

  • postoperative pain score

    postoperative pain score evaluated with Visual Analog Scale

    postoperative 12. hour

  • postoperative pain score

    postoperative pain score evaluated with Visual Analog Scale

    postoperative 24. hour

  • postoperative pain score

    postoperative pain score evaluated with Visual Analog Scale

    postoperative 48. hour

Secondary Outcomes (2)

  • postoperative analgesic consumption

    postoperative 48 hours

  • postoperative passing of gas and bowel movements

    postoperative 48 hours

Study Arms (2)

case (SHPB+)

Superior hypogastric plexus block present

control (SHPB-)

Superior hypogastric plexus block not present

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy, pregnant, literate women having cesarean-section operation with general anesthesia at H.S.U Kocaeli Derince Education and Research Hospital Obstetrics and Gynecology Clinics

You may qualify if:

  • Pregnant women having cesarean-section operation at H.S.U Kocaeli Derince Education and Research Hospital with general anesthesia,
  • Women agree to participate in the study,
  • Literate women.

You may not qualify if:

  • Women having cesarean-section with spinal anesthesia,
  • Women with known bupivacaine and NSAIDS allergy,
  • Women with anxiety-depression disorder,
  • Women with known fibromyalgia.
  • Insufficient ability to understand information in Turkish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S.B.U Kocaeli Derince Education and Research Hospital

Kocaeli, 41100, Turkey (Türkiye)

Location

Study Officials

  • bahar sarıibrahim astepe, M.D

    S.B.U Kocaeli Derince Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
obstetrics and gynecology specialist

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 9, 2018

Study Start

March 15, 2018

Primary Completion

March 15, 2019

Study Completion

March 15, 2019

Last Updated

March 19, 2019

Record last verified: 2019-03

Locations

TU(1)