Prevalence of Pain During Cesarean Section
ConditionCesarean Birth
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorWomen's Hospital HUS
About this trial
200 parturients coming for an elective cesarean delivery will receive a standard neuraxial anesthesia for the operation consisting of a spinal anesthetic and an epidural catheter (combined spinal epidural anaesthesia).
The parturients are asked a verbal rating by a paper form within 2 hours after the operation asking if they experienced pain during surgery (none; at times; half the time; most of the time; all the time). Additionally the intensity of the pain that was potentially experienced is asked on a 0-10 numeral rating scale (0= no pain; 10 = worst possible pain).
The primary outcome of the study is the proportion of parturients reporting either existence of some pain (answer other than "none" to the question asking about pain during surgery) OR reporting maximum pain during surgery of 4 or more on the 0-10 NRS scale.
The observed outcome is compared against the previously reported incidense of 18 % when using combied spinal epidural anesthesia for the cesarean section.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Pregnant women coming for elective cesarean delivery which is planned to be completed under combined spinal epidrual anaesthesia.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Combined spinal and epidural anesthesia
Procedure/SurgeryAnesthesia for a planned cesarean delivery by spinal anesthesia and epidural catheter installed at the same time with the spinal anesthesia
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Elective cesarean section under combined spinal epidural anesthesia1 intervention
Trial outcomes
Primary outcomes
1
Pain during cesarean section
Report of experiencing pain during surgery when asked within two hours after the end of surgery or maximum pain numeral rating scale value of four or more on a 0-10 scale (0=no pain; 10=worst possible pain).
Time frame
During the operationSecondary outcomes
1
Association of patient, operation or anaesthesia related factors with the experience of pain during surgery (as defined in the primary outcome)
Duration of surgery, experience of the anesthesiologist, dose of spinal (local) anesthetic, testing of the block prior to surgery
Time frame
During surgeryOther outcomes
1
Correlation between the anesthesiologist's perception of pain during surgery and patient reported actual pain during surgery.
Both the anestheiologist and the parturient are asked to assess the pain experinced by the parturient. The possible existence of a linear correlation between these assessments is tested.
Time frame
During surgery2
Quality of recovery
Quality of recovery is followed using QoR-15 questionnaire
Time frame
Five measurements done at before ward transfer at the recovery room, before discharge from hospital and 7, 14 and 30 days after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Women's Hospital HUS
Lead sponsor
Oulu University Hospital
Collaborator
Kuopio University Hospital
Collaborator
University of Eastern Finland
Collaborator
Source ClinicalTrials.gov
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