NCT02332395

Brief Summary

The aim of this study is to determine the effect of surgical priority either emergency or elective on postoperative pain in caesarean section operations. Patients whose undergo caesarean section operation are included into this study. Patients will invite to complete the Pain Catastrophizing Scale questionnaire in preoperative period. The patients will be divided into two groups in terms of applied surgical priority whether emergency or elective. After caesarean section, patient controlled analgesia is used for pain relief. And the intensity of pain will be measured by using numerical rating scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2013

Typical duration 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

Study Start

First participant enrolled

December 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

2.4 years

First QC Date

January 5, 2015

Last Update Submit

April 18, 2017

Conditions

Pain

Keywords

painpain catastrophizingcesarean section

Outcome Measures

Primary Outcomes (1)

  • Total amount of analgesics

    24 hours

Secondary Outcomes (2)

  • numerical rating scale

    24 hours

  • pain catastrophizing scale

    1 year

Study Arms (2)

Emergency caesarean section

patients whose underwent emergency caesarean section operation

Elective caesarean section

patients whose underwent elective caesarean section operation

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

individuals whose underwent caesarean section operation in terms of surgical priority whether emergency or elective

You may qualify if:

  • American Society of Anesthesiologists score of 1 or 3 and 1-Emergency or 3-Emergency

You may not qualify if:

  • Patients whose not to participate
  • Patients whose have communication problems
  • Patients whose have been using antipsychotic or antidepressant drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa University

Tokat Province, Tokat Province, 60200, Turkey (Türkiye)

Location

Related Publications (3)

  • Taşdemir A, Erakgün A, Nuri Deniz M, ÇertuğA . Preoperatif Bilgilendirme Yapılan Hastalarda Ameliyat öncesi ve Sonrası Anksiyete Düzeylerinin State-Trait Anxiety Inventory Test ile Karşılaştırılması. Turkish Journal Anaesthesiology and Reanimation 41(2): 44-9, 2013.

    BACKGROUND

  • Kırdemir P, Özorak Ö. Postoperatif Ağrı ve Analjezik İhtiyacı Preoperatif Dönemde Tahmin Edilebilir mi? Turkiye Klinikleri Journal of Medical Sciences 31(4):951-9, 2011.

    BACKGROUND

  • Hüseyinoğlu Ü, Ülker K, Temur İ, Kütük M. Elektif Sezaryen Doğum Sonrası Postoperatif Ağrı Gideriminde Meperidin ve Tramadolün Karșılaștırılması: Bir Prospektif Randomize Çalıșma. Kafkas Journal of Medical Sciences 1(2):53-56, 2011.

    BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hakan Tapar, Ass.Prof, MD

    Gaziosmanpasa University, Medical Faculty, Department of Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, MD

Study Record Dates

First Submitted

January 5, 2015

First Posted

January 6, 2015

Study Start

December 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

April 19, 2017

Record last verified: 2017-04

Locations

TU(1)