Prevalence of Pain During Cesarean Section

NCT07851441 | Not Yet Recruiting

• 1 other identifier: Suunnitelma11_11_2025
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Cesarean Birth

Keywords

observational study; spinal anesthesia; cesarean section; pain during surgery

Outcome Measures

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).

  During the operation

Secondary Outcomes (1)

• Association of patient, operation or anaesthesia related factors with the experience of pain during surgery (as defined in the primary outcome)

  During surgery

Other Outcomes (2)

• Correlation between the anesthesiologist's perception of pain during surgery and patient reported actual pain during surgery.

  During surgery

• Quality of recovery

  Five measurements done at before ward transfer at the recovery room, before discharge from hospital and 7, 14 and 30 days after surgery

Study Arms (1)

Elective cesarean section under combined spinal epidural anesthesia

200 parturients coming for elective cesarean section to be performed under combined spinal epidural anesthesia.

Procedure: Combined spinal and epidural anesthesia

Interventions

Combined spinal and epidural anesthesia PROCEDURE

Anesthesia for a planned cesarean delivery by spinal anesthesia and epidural catheter installed at the same time with the spinal anesthesia

Elective cesarean section under combined spinal epidural anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women coming for elective cesarean delivery which is planned to be completed under combined spinal epidrual anaesthesia.

You may qualify if:

• Coming for elective cesarean delivery Speaks and reads sufficient Finnish to understand the concent forms and fill the questionnaire.

You may not qualify if:

• Planned anaesthesia mode other than combined-spinal epidural anaesthesia for any reason.

Sponsors & Collaborators

• Kuopio University Hospital: collaborator
• Women's Hospital HUS: lead
• Oulu University Hospital: collaborator
• University of Eastern Finland: collaborator

Study Sites (3)

Women's hospital, Helsinki University Hospital

Helsinki, Finland

Location

Kuopio University Hospital

Kuopio, 70211, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Related Publications (1)

• Charles EA, Carter H, Stanford S, Blake L, Eley V, Carvalho B, Sultan P, Kua J, O'Carroll JE. Intraoperative Pain during Cesarean Delivery under Neuraxial Anesthesia: A Systematic Review and Meta-analysis. Anesthesiology. 2025 Jul 1;143(1):156-167. doi: 10.1097/ALN.0000000000005486. Epub 2025 Apr 4.

  PMID: 40184602 BACKGROUND

MeSH Terms

Interventions

Anesthesia, Epidural

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Merja Kokki, MD PhD Professor

  University of Eastern Finland

  STUDY DIRECTOR

• Terhi Kivela, MD PhD

  Oulu University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Terhi Kivelä, MD

CONTACT

+35883152093; terhi.m.kivela@pohde.fi

Antti J Vaananen, MD PhD

CONTACT

358504271850; antti.vaananen@hus.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of anaesthesia department

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: October 1, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (3)