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Pain After Scheduled Cesarean Delivery: Spinal Morphine With or Without Levobupivacaine Wound Infiltration
Sponsor: Fundación Santa Fe de Bogota
Summary
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.
Official title: Postoperative Pain Control After Cesarean Delivery: Intrathecal Morphine With or Without Adjunctive Fascial Levobupivacaine Infiltration. A Prospective Observational Cohort Study
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
336
Start Date
2026-10-14
Completion Date
2027-09-14
Last Updated
2026-10-06
Healthy Volunteers
No
Interventions
Levobupivacaine
Subcutaneous and subfascial wound infiltration with levobupivacaine 0.75%, 75 mg (one 10 mL ampoule diluted in 10 mL of saline, total 20 mL), performed after closure of the aponeurosis at the end of cesarean delivery, as part of the attending obstetrician's usual practice. Given in addition to the same standard institutional multimodal analgesia received by all participants: intrathecal morphine plus fentanyl, ketorolac, acetaminophen, celecoxib and hyoscine butylbromide, with systemic opioid rescue as needed. Not assigned by the investigators.
Intrathecal Morphine
Single-dose intrathecal morphine plus fentanyl given with spinal anesthesia for cesarean delivery, as part of the standard institutional multimodal analgesia protocol (with ketorolac, acetaminophen, celecoxib and hyoscine butylbromide; systemic opioid rescue as needed).
Locations (1)
Fundación Santa Fe de Bogotá
Bogotá, Bogota D.C., Colombia