Cesarean Section Complications Clinical Trial
Official title:
Monocentric Observational Study: Postoperative Pain After Cesarean Section: Incidence and Risk Factors.
NCT number | NCT04280432 |
Other study ID # | PI-2564 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2017 |
Est. completion date | September 30, 2018 |
Verified date | September 2019 |
Source | Instituto de Investigación Hospital Universitario La Paz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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)
Status | Completed |
Enrollment | 610 |
Est. completion date | September 30, 2018 |
Est. primary completion date | September 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario La Paz | Madrid |
Lead Sponsor | Collaborator |
---|---|
Instituto de Investigación Hospital Universitario La Paz |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Asses if age of patients, measured as years, is a risk factor for chronic post surgical pain | Pain intensity was assessed as average pain at rest and on movement during the past 24 h using NRS and DN2 questionnaire 24 hours, one week and three months after surgery. | One week and three months. | |
Other | Asses if gestational age of patients, measured as week of gestation, is a risk factor for chronic post surgical pain | Pain intensity was assessed as average pain at rest and on movement during the past 24 h using NRS and DN2 questionnaire 24 hours, one week and three months after surgery. | One week and three months. | |
Other | Asses if toxic habits of patients, measured as yes/no question: tobacco yes/no and drugs yes/no , is a risk factor for chronic post surgical pain | Pain intensity was assessed as average pain at rest and on movement during the past 24 h using NRS and DN2 questionnaire 24 hours, one week and three months after surgery. | One week and three months. | |
Other | Asses if body mass index of patients, measured as kg/ m2, is a risk factor for chronic post surgical pain | Pain intensity was assessed as average pain at rest and on movement during the past 24 h using NRS and DN2 questionnaire 24 hours, one week and three months after surgery. | One week and three months. | |
Other | Asses if previous vaginal delivery, measured as yes/no question: previous vaginal delivery yes/no, is a risk factor for chronic post surgical pain. | Pain intensity was assessed as average pain at rest and on movement during the past 24 h using NRS and DN2 questionnaire 24 hours, one week and three months after surgery. | One week and three months. | |
Other | Asses if previous cesarean delivery, measured as yes/no question: previous cesarean delivery yes/no, is a risk factor for chronic post surgical pain. | Pain intensity was assessed as average pain at rest and on movement during the past 24 h using NRS and DN2 questionnaire 24 hours, one week and three months after surgery. | One week and three months. | |
Other | Asses if previous chronic pelvic pain disorder, measured as a yes/no question: chronic pelvic pain disorder yes/no, is a risk factor for chronic post surgical pain | Pain intensity was assessed as average pain at rest and on movement during the past 24 h using NRS and DN2 questionnaire 24 hours, one week and three months after surgery. | One week and three months. | |
Other | Asses if urgency level os cesarean, using classification proposed by lucas et al. is a risk factor for chronic post surgical pain | Classification relating the degree of urgency to the presence or absence of maternal or fetal compromise: Immediate threat to life of woman or fetus No inmediata threat to life of woman or fetus Requires early delivery At a time to suit the woman and maternity services. Pain intensity was assessed as average pain at rest and on movement during the past 24 h using NRS and DN2 questionnaire 24 hours, one week and three months after surgery. |
One week and three months. | |
Other | Asses if anesthetics technique before cesarean section (epidural for labour) information recruited as yes/no epidural for labour, is a risk factor for chronic post surgical pain | Pain intensity was assessed as average pain at rest and on movement during the past 24 h using NRS and DN2 questionnaire 24 hours, one week and three months after surgery. | One week and three months. | |
Other | Asses if preoperative use of oxytocin during labour, information recruited as yes/no use of oxytocin during labour, is a risk factor for chronic post surgical pain. | Pain intensity was assessed as average pain at rest and on movement during the past 24 h using NRS and DN2 questionnaire 24 hours, one week and three months after surgery. | One week and three months. | |
Other | Asses if kind of surgical incision: pfannenstiel or vertical is a risk factor for chronic post surgical pain. | Pain intensity was assessed as average pain at rest and on movement during the past 24 h using NRS and DN2 questionnaire 24 hours, one week and three months after surgery. | One week and three months. | |
Other | Asses if closure of peritoneum: information recruited as yes/no question: closure of peritoneum yes/no, is a risk factor for chronic post surgical pain. is a risk factor for chronic post surgical pain. | Pain intensity was assessed as average pain at rest and on movement during the past 24 h using NRS and DN2 questionnaire 24 hours, one week and three months after surgery. | One week and three months. | |
Other | Asses if closure uterine exteriorization: information recruited as yes/no question: uterine exteriorization yes/no, is a risk factor for chronic post surgical pain. is a risk factor for chronic post surgical pain. | Pain intensity was assessed as average pain at rest and on movement during the past 24 h using NRS and DN2 questionnaire 24 hours, one week and three months after surgery. | One week and three months. | |
Other | Asses if duration of surgery (minutes) is a risk factor for chronic post surgical pain. is a risk factor for chronic post surgical pain. | Pain intensity was assessed as average pain at rest and on movement during the past 24 h using NRS and DN2 questionnaire 24 hours, one week and three months after surgery. | One week and three months. | |
Other | Asses if anesthesia technique for cesarean section (general, epidural, combined or intradural) is a risk factor for chronic post surgical pain. | Pain intensity was assessed as average pain at rest and on movement during the past 24 h using NRS and DN2 questionnaire 24 hours, one week and three months after surgery. | One week and three months. | |
Primary | 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) | 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. | three months | |
Secondary | 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. | 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. | Three months |
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