NCT02373696

Brief Summary

Incidence and risk factors for persistent post surgical pain after Caesarean section are investigated. Demographic, psychophysical testing and genetic screening factors are performed in the perioperative period. Phone survey is performed to investigate the incidence of persistent post surgical pain after Caesarean section.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
178

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2010

Longer than P75 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

April 1, 2010

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
Last Updated

September 4, 2015

Status Verified

September 1, 2015

Enrollment Period

4.8 years

First QC Date

February 22, 2015

Last Update Submit

September 3, 2015

Conditions

Pain

Keywords

PainCaesarean section

Outcome Measures

Primary Outcomes (1)

  • Persistent Postsurgical Pain

    Pain experienced in the lower abdominal region and surgical area after Caesarean section

    12 weeks

Eligibility Criteria

Age21 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women undergoing spinal anaesthesia for Caesarean section

You may qualify if:

  • Women undergoing spinal anaesthesia for Caesarean section

You may not qualify if:

  • Failed spinal anaesthesia, Unable to perform psychophysical testing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women's and Children's Hospital

Singapore, Singapore, 229899, Singapore

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sampling

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ban L Sng, FANZCA

    KK Women's and Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2015

First Posted

February 27, 2015

Study Start

April 1, 2010

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

September 4, 2015

Record last verified: 2015-09

Locations

SG(1)