NCT00374504

Brief Summary

The aim of this study is to evaluate a possible correlation between predictive precesarean section pain and development of postcaesarean section pain using the PM. Patients and Methods 46 healthy pregnant women scheduled for elective cesarean section is included after informed consent. The standard operation procedures included spinal anesthesia, paracetamol 1 g 8 hourly, diclofenac 50 mg 8 hourly and oxycontine 10 mg x 2. Morphine was used for break-through pain. Before cesarian section the threshold for sensory and pain were measured 3 times, and the average was used for analyses. After cesarian section a blinded midwife assess the pain at rest and during mobilization every 12th hours over 2 days score. Data was analyzed using AUC and non-parametric test, P \< 0,05.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2006

Completed
Last Updated

September 11, 2006

Status Verified

February 1, 2006

First QC Date

September 8, 2006

Last Update Submit

September 8, 2006

Conditions

Cesarean Section

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy pregnant women scheduled for elective cesarean section

You may not qualify if:

  • ASA III -IV
  • Chronic pain conditions.
  • Pacemaker.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital, Rrigshospitalet

Copenhagen, dk-2100, Denmark

Location

Related Publications (1)

  • Nielsen PR, Norgaard L, Rasmussen LS, Kehlet H. Prediction of post-operative pain by an electrical pain stimulus. Acta Anaesthesiol Scand. 2007 May;51(5):582-6. doi: 10.1111/j.1399-6576.2007.01271.x.

    PMID: 17430320DERIVED

Study Officials

  • Per Rotbøll Nielsen, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2006

First Posted

September 11, 2006

Last Updated

September 11, 2006

Record last verified: 2006-02

Locations

DK(1)