Clinical Trials Logo

Clinical Trial 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)


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04280432
Study type Observational
Source Instituto de Investigación Hospital Universitario La Paz
Contact
Status Completed
Phase
Start date March 1, 2017
Completion date September 30, 2018

See also
  Status Clinical Trial Phase
Terminated NCT04377984 - Impact of a Strategy Combining Morphine Savings and Anesthesia Technique on the Quality of Post-operative Rehabilitation
Recruiting NCT03248817 - Phenylephrine Infusion in Cesarean Delivery Phase 4
Completed NCT05037383 - Motion and Viewing Analysis of Surgeons During Minimally Invasive Gynecological Interventions N/A
Not yet recruiting NCT05933993 - Mothers Experience of Pain Following Elective Cesarean Section. A Qualitative Study.
Recruiting NCT05021315 - Vaginal Cleaning Using Povidone Iodine Before CS to Reduce Postoperative Wound Infection Phase 3
Terminated NCT03246919 - Ideal Time of Oxytocin Infusion During Cesarean Section Phase 4
Recruiting NCT06010368 - Comparing Intramyometrial Tranexamic Acid and Oxytocin for Blood Loss in Cesarean Section Phase 3
Recruiting NCT06247852 - Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study
Not yet recruiting NCT06017076 - Effect of Preoperative Oral Energy Drinks Compared to Warming Matress on Body Temperature During Combined Spinal-epidural Anesthesia for Elective Cesarean Delivery. N/A
Completed NCT05005871 - Comparison of Quadratus Lumborum Intramuscular and Transmuscular in Postoperative Pain N/A
Recruiting NCT04518176 - Bilateral Uterine Artery Ligation During the Cesarean Delivery of Twins N/A
Not yet recruiting NCT04505644 - Lidocaine Patch Versus Intravenous Lidocaine in Pain Relief After Cesarean Section N/A
Not yet recruiting NCT03985618 - The MODE Trial: Planned Caesarean Section Versus Induction of Labour for Women With Class III Obesity N/A
Completed NCT04046510 - Comparaison of 3 Protocols of Ocytocin Administration in C Section N/A
Completed NCT03302039 - Three Protocols for Phenylephrine Administration in Cesarean Delivery Phase 4
Completed NCT03318536 - Effect of Granisetron on Usage of Sympathomimetics During Caesarean Section
Recruiting NCT03682510 - B-Lynch Transverse Compression Suture Versus a Sandwich Technique (N&H Technique) for Complete Placenta Previa N/A
Recruiting NCT03651076 - Traxi Panniculus Retractor for Cesarean Delivery N/A
Not yet recruiting NCT06060327 - Comparing Tranexamic Acid Versus Ecbolics in Preventing Hemorrhage During and After Cesarean Section N/A
Completed NCT03701048 - Rectus Musle Reapproximation During Cesarean Section N/A