Pain Management After Cesarean Section - A Before-and-After Cohort Study

NCT06813638 | Completed

• 1 other identifier: 102
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Inadequate pain relief remains a challenge after Cesarean section (CS) and may significantly impair postoperative recovery. A recent Danish single-center study (n=100) revealed that 66% of elective CS patients experienced severe pain (NRS ≥ 7) during the first 24 hours, with the highest pain scores occurring within the initial 12 hours. To optimize postoperative pain management for CS patients at the same study center, the investigators have implemented recommendations for pain management from the PROSPECT guideline for procedure-specific postoperative pain management after CS, as recommended by the European Society of Regional Anaesthesia \& Pain Therapy. The study center had already been adhering to the guidelines concerning postoperative care and surgical technique. The investigators have now implemented the second PROSPECT recommendation, focusing on the intraoperative management after delivery, and implemented wound infiltration in combination with an ilio-inguinal field block, before closing the incision after CS, and intravenous dexamethasone (8mg), administered immediately after birth of the baby during CS. The investigators designed a before-and-after study with the aim of investigating whether the new practice of adding wound infiltration, an ilio-inguinal field block, and intravenous dexamethasone intraoperatively reduces the incidence of postoperative pain in the early period following CS.

Conditions

Cesarean Section; Cesarean Delivery; Pain Management; Pain Management in Postoperative Care; Postoperative Pain; Cohort Study; Text Message; Patient Reported Outcome; Wound Infiltration

Keywords

Pain after cesarean; cesarean delivery; cesarean section; postoperative pain; patient reported outcome; Text message; wound infiltration; pain management; cohort

Outcome Measures

Primary Outcomes (1)

• Pain at movement at 6 hours after Cesarean Section

  Patient reported pain when moving from lying to sitting position, Numeric Rating Scale 0-10, 0=no pain, 10=worst possible pain.

  6 hours, questionnaire at 6 hours after cesarean section

Secondary Outcomes (8)

• Pain at movement at 12 hours after Cesarean Section

  12 hours, questionnaire at 12 hours after cesarean section

• Severe pain (NRS ≥ 7) at any time within the first 24 hours after Cesarean Section

  24 hours, questionnaires at 6, 12, 18, 24 hours after cesarean section

• Opioid consumption during the first 24 hours after CS. (oral morphine equivalents, mg)

  24 hours

• Pain at movement at 18 hours after Cesarean Section

  18 hours, questionnaire at 18 hours after cesarean section

• Pain at movement at 24 hours after Cesarean Section

  24 hours, questionnaire at 24 hours after cesarean section

Study Arms (1)

Elective Cesarean Section patients

Our Danish hospital in the Capital Region handles approximately 4,000 births including 400 elective CS annually (Danish birth registry). We evaluate the routinely used protocols in our center before and after modification of the standard protocol. We have a sample size of 100 historical CS patients with prospective data collection from before the implementation. The patients were included in a study testing the feasibility of electronic text messages for questionnaires on pain from December 2022 to June 2023 (Duch). In this study we plan to include elective CS patients after the implementation in a period between January 2025 and April 2025.

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

Elective CS Patients at our center will be approached for inclusion in the postoperative care unit shortly after the CS during the study period

You may qualify if:

• Patients who undergo planned cesarean section under spinal anesthesia.
• Patients who speak and read Danish and can provide informed consent to participate.
• Patients who have a mobile phone that can receive a text message with a link to a questionnaire that can be accessed on an online website on the phone.
• Age ≥ 18 years

You may not qualify if:

• The study excludes patients with daily opioid use.
• Multiple pregnancies (gemelli or more).
• Insulin-treated diabetes.
• Chronic pain patients.
• Unplanned CS

Sponsors & Collaborators

• Nordsjaellands Hospital: lead
• Hillerod Hospital, Denmark: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (1)

University Hospital of Copenhagen, Northern Zealand

Hillerød, 3400, Denmark

Location

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Study Officials

• Patricia Duch, MD

  Department of Anaesthesia, University Hospital of Copenhagen, Northern Zealand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, MD

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: February 7, 2025
• Study Start: January 7, 2025
• Primary Completion: June 10, 2025
• Study Completion: June 10, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be collected, analyzed and drafted for publication in 2025.
• Access Criteria: The study protocol is uploaded with the registration on Clinical trials 1th February 2025.

Locations

DK (1)