Monocentric Observational Study: Postoperative Pain After Cesarean Section: Incidence and Risk Factors.

Completed

• Conditions: Chronic Postoperative Pain; Cesarean Section Complications
• Interventions: Procedure: CESAREAN

• Registration Number: NCT04280432
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

Brief Summary

The purpose of this prospective study was to assess chronic pain 3, and 12 months after cesarean delivery in a cohort of women in University hospital La Paz. We also aim to study the possible contribution of anesthetic and surgical risk factors for the development of Chronic post-surgical pain after cesarean (PCSCP)

Detailed Description

* This prospective observational cohort study was conducted at University hospital La Paz. Women hospitalized for cesarean section from March 2017 to September 2018 were recruited on the hospital on the day of surgery, when research interviewers were available. Patients who agreed to participate were interviewed in person preoperatively,at discharge from Reanimation and 24 h postoperatively. Telephone follow-up interviews were conducted one week and 3,and 12 months following surgery. Intraoperative information was collected from the patient record or directly filled by a research person. Questionnaires applied in the present study are reflected in file 1.

* Study participants had to be aged between 18 and 50 years and American Society of Anesthesiologists scale (ASA) had to be I, II or III The exclusion criteria were history of major psychiatric disorder and inability to undertake a personal or telephone interview, ASA\> III or dead fetus as result of caesarean section. The study was approved by the local ethics committee (registration number: PI-2564), and written informed consent was obtained from all patients.

Questions about age, race, gestational age, toxic habits, body mass index (BMI) (that was calculated from height and weight) previous vaginal delivery, cesarean delivery, other demographic, medical, surgical, and pre- operative pain variables were included.

-Were also recruited information about urgency level of caesarean using the classification proposed by Lucas et al.use of preoperative oxytocin, anesthesic technique before caesarean section (for example epidural for labor) and surgical and anesthesia variables.

Patients were visited within 24 h after surgery. Pain intensity was assessed as average pain at rest and on movement during the past 24 h using (NRS) and DN2 questionnaire. Also analgesic consumption and relevant side effects or complications were annotated.

Assessment after 3, and 12 months

-Patients were contacted by telephone by one of the authors at 3, and 12 months following cesarean section. This telephone interview usually takes no longer than 15 min. Chronic postsurgical pain (CPSP) was measured using the short form Brief Pain Inventory (BPI) BPI assesses the severity of pain and its impact on functioning. The pain severity items are presented as numeric rating scale (NRS). The patients were asked to rate their pain at rest and during movement in the previous week of the survey. Items of pain interference on function (general activity, mood, walking, work, relations with others, sleep and enjoyment of life ) are also presented as numeric rating scale (NRS) , are valued with 0 = does not interfere and 10 = interferes completely. There were also questions consumption of analgesics and neuropathic pains symptoms using Neuropathic pain (DN2) questionnaire.

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30
• Status Verified: 2019-09
• Study First Submitted: 2019-09-12
• Study First Submitted QC: 2020-02-19
• Study First Posted: 2020-02-21
• Last Update Submitted: 2020-06-11
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 610

Inclusion Criteria

• Anesthesiologists scale (ASA) had to be I, II or III

Exclusion Criteria

• history of major psychiatric disorder and inability to undertake a personal or telephone interview, ASA> III or dead fetus as result of caesarean section

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cesarean	CESAREAN	Women hospitalized for cesarean section

Primary Outcome Measures

Name	Time	Method
assess if clinically relevant pain measured by neuropathic pain questionnaire of 2 questions (DN2) > 3/10 one week after cesarean section(CS) was a risk factor for chronic post-surgical pain (CPSP)	three months	Asses chronic pain 3 months after cesarean delivery in a cohort of women in University Hospital La Paz.A telephone interview with DN2 questionnaire was performed to all patients one week after surgery to assess the presence of neuropathic pain. CPSP diagnosis was retained in patients with the persistence of any symptom of pain or discomfort in the surgical site in the previous week, with an NRS score superior to 3/10 at rest and/or during movement 3 months after surgery.

Secondary Outcome Measures

Name	Time	Method
assess whether a pain intensity superior to 5/10 on the NRS one week after Cesarean Section was related to a higher incidence of CPSP at three months.	Three months	Asses chronic pain 3 months after cesarean delivery in a cohort of women in University Hospital La Paz. A telephone interview with Numeric Rating Scale (NRS) questionnaire was performed to all patients one week after surgery to assess the presence of moderate pain. (No pain: NRS=0; Mild pain: NRS=1-3; Moderate pain: NRS= 4-6; Severe pain=7-10) CPSP diagnosis was retained in patients with the persistence of any symptom of pain or discomfort in the surgical site in the previous week, with an NRS score superior to 3/10 at rest and/or during movement 3 months after surgery.

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain