Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pain After Cesarean Sectio.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03730246
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Johan C Ræder, Oslo University Hospital

Tracking Information
First Submitted Date November 1, 2018
First Posted Date November 5, 2018
Last Update Posted Date November 5, 2018
Actual Study Start Date August 1, 2018
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 1, 2018)
postoperative pain strenght [ Time Frame: 0-24 hrs ]
NRS pain
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 1, 2018)
rescue drug needed [ Time Frame: 0-24 hrs ]
dose of rescue opioid drug
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pain After Cesarean Sectio.
Official Title Postoperative Pain 0-24 hr After Cesarean Sectio
Brief Summary To study the strength of postoperative pain 0-24 hrs after elective cesarean sectio in spinal anaesthesia.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population all patients due for cesarean sectio are eligible
Condition
  • Pain
  • Analgesic Medication
Intervention Procedure: cesarean sectio
consecutive parturients due for cesarean sectio
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 1, 2018)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 31, 2019
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • cesearean sectio

Exclusion Criteria:

  • none
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages up to 50 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT03730246
Other Study ID Numbers Sectio.Pain.Jenny
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Johan C Ræder, Oslo University Hospital
Study Sponsor Oslo University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Oslo University Hospital
Verification Date November 2018