Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07859956 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Pain After Scheduled Cesarean Delivery: Spinal Morphine With or Without Levobupivacaine Wound Infiltration

Study acronym: LEVO-CS
StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
The goal of this observational study is to learn whether injecting a numbing medicine (levobupivacaine, a local anesthetic) into the surgical wound at the end of a cesarean delivery improves pain control in women who also receive spinal morphine. Spinal morphine is the standard pain treatment for cesarean delivery. The main questions it aims to answer are: Do women who receive wound infiltration with levobupivacaine report less pain at 24 hours, 48 hours, and 7 days after surgery than women who do not? Do they have a better quality of recovery, measured with the ObsQoR-10 questionnaire? Do they walk for the first time sooner, and do they need less additional ("rescue") pain medicine in the first 24 hours? Researchers will compare two groups of women having a scheduled cesarean delivery under spinal anesthesia at Fundación Santa Fe de Bogotá (Bogotá, Colombia). In the first group, the surgeon routinely infiltrates the wound with levobupivacaine when closing. In the second group, the surgeon does not. The study team does not decide which women receive the medicine; this depends only on each surgeon's usual practice. All participants receive the same standard hospital pain treatment: spinal morphine, acetaminophen, and anti-inflammatory medicines. Participants will: Receive their usual cesarean care, with no extra procedures because of the study. Answer short online questionnaires sent by WhatsApp or email at 24 hours, 48 hours, and 7 days after surgery. They will rate their pain on a 0-10 scale at each time point and their recovery with the ObsQoR-10 questionnaire at 24 hours. Receive a phone call on day 7 reminding them to complete the last questionnaire. Allow the research team to collect information from their medical record, such as the time to first walk and the use of rescue pain medicine. The study plans to include 336 women over about 10 months.
Trial Details
NCT Number NCT07859956
Lead Sponsor Fundación Santa Fe de Bogota
Conditions
(from sponsor)
Pain Management, C Section, Obstetric Pain, Levobupivacaine
Related terms Agnosia, Labor Pain, Postoperative Pain
Enrollment 336 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov