Postoperative Pain Control After Cesarean Delivery: Intrathecal Morphine With or Without Adjunctive Fascial Levobupivacaine Infiltration. A Prospective Observational Cohort Study
| Registry | NCT07859956, acronym LEVO-CS |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 336 (Estimated) |
| Sponsor | Fundación Santa Fe de Bogota (Other) |
| Conditions | Pain Management, C Section, Obstetric Pain, Levobupivacaine |
| Interventions | Levobupivacaine, Intrathecal Morphine (Drug) |
| Dates | start 2026-10-14 (estimated), primary completion 2027-07-14 (estimated), completion 2027-09-14 (estimated), first posted 2026-10-06, last updated 2026-10-06 |
| Locations | 1 site in Colombia |
Related Papers Related Patents Related Grants Related Experts
All trials for Pain Management All trials for C Section All trials of Levobupivacaine All trials of Intrathecal Morphine
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.
Background and rationale Intrathecal morphine is the gold standard for analgesia after cesarean delivery. However, 25-80% of women still report moderate to severe pain during the first 24-48 hours. Poorly controlled pain may delay mobilization, increase systemic opioid use, interfere with breastfeeding and newborn care, and has been associated with chronic pain and postpartum depression. International recommendations (PROSPECT, ERAS) support multimodal analgesia. Local anesthetic wound infiltration is simple, inexpensive and reproducible, but evidence on its added benefit over intrathecal morphine is limited and heterogeneous in dose, technique and anatomical plane. Levobupivacaine, the pure S-enantiomer of bupivacaine, has lower cardiovascular and central nervous system toxicity.
Design This is a prospective, single-center, analytical observational cohort study at Fundación Santa Fe de Bogotá, a high-complexity teaching hospital in Bogotá, Colombia, with about 2,000 births per year. Patients are enrolled consecutively over 10 months. Exposure is determined only by the usual clinical practice of each attending obstetrician. The investigators do not assign, randomize or suggest the exposure.
Exposure Exposed cohort: subcutaneous and subfascial infiltration with levobupivacaine 0.75%, 75 mg (one 10 mL ampoule diluted in 10 mL of saline), after closure of the aponeurosis. The drug is Bupinest®, INVIMA registration 2016 M-013339-R2. The total local anesthetic dose, including the spinal dose, stays within the maximum of 2 mg/kg.
Unexposed cohort: no wound infiltration.
Standard institutional analgesia (both cohorts) Spinal anesthesia with intrathecal morphine 100 mcg and fentanyl 25 mcg. Ketorolac 30 mg IV after delivery of the newborn. Acetaminophen 1 g IV at the end of surgery. During the 48-hour hospital stay: oral celecoxib every 12 hours (unless contraindicated), oral acetaminophen 1 g every 8 hours, and IV hyoscine butylbromide 20 mg every 8 hours.
Rescue systemic opioid for pain score >7 or at the patient's request.
Blinding and data collection Outcome assessment and statistical analysis are blinded to exposure. Patient-reported outcomes (pain scale and the validated Spanish version of the ObsQoR-10) are self-administered through automated REDCap surveys sent by WhatsApp or email, which reduces inter-observer variability. Clinical and surgical data are taken from the electronic medical record.
Sample size Sample size was calculated with Epidat 4.2 for comparison of two independent means, using 24-hour pain scores from published data. The parameters were 95% confidence, 80% power and a 1:1 ratio. The result is 336 participants (168 per cohort).
Statistical analysis Pain trajectory (24 h, 48 h, 7 days): linear mixed model for repeated measures. Fixed effects are exposure, time and the exposure × time interaction; the patient is a random effect. Mean between-group differences at each time point are reported with 95% CIs. If model assumptions are not met, robust or ordinal models will be used.
Secondary outcomes:
Time to first ambulation: t-test or Mann-Whitney, and Kaplan-Meier with log-rank if exact times are available.
Rescue analgesia: chi-square or Fisher's exact test, and logistic regression. ObsQoR-10: as a continuous score, and dichotomized at ≥70 points as good recovery.
Adjusted models: multivariable models adjust for confounders, including maternal age, BMI and previous cesarean delivery.
Exploratory subgroups: age, parity, BMI category and previous cesarean delivery.
Significance is set at p <0.05. The analysis will be done in Rstudio.
Ethics The study is classified as minimal risk under Colombian Resolution 8430 of 1993. It has been approved by the Corporate Research Ethics Committee (CCEI) of Fundación Santa Fe de Bogotá. As an observational Phase IV study of a marketed medicine, it will be notified to INVIMA, the Colombian National Food and Drug Surveillance Institute, before enrollment begins. All participants give electronic informed consent through REDCap. Results will be published regardless of direction.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Levobupivacaine wound infiltration | Drug: Levobupivacaine; Drug: Intrathecal Morphine | Women undergoing scheduled cesarean delivery under spinal anesthesia with intrathecal morphine and fentanyl whose attending obstetrician, as part of usual clinical practice, performs subcutaneous and subfascial wound infiltration with levobupivacaine 0.75% (75 mg, one 10 mL ampoule diluted in 10 mL of saline) after closure of the aponeurosis. Participants also receive standard institutional multimodal analgesia: ketorolac, acetaminophen, celecoxib and hyoscine butylbromide, with systemic opioid rescue as needed. Exposure is not assigned by the investigators. | |
| No wound infiltration | Drug: Intrathecal Morphine | Women undergoing scheduled cesarean delivery under spinal anesthesia with intrathecal morphine and fentanyl whose attending obstetrician, as part of usual clinical practice, does not perform wound infiltration with local anesthetic. Participants receive the same standard institutional multimodal analgesia: ketorolac, acetaminophen, celecoxib and hyoscine butylbromide, with systemic opioid rescue as needed. Exposure is not assigned by the investigators. |
Sex: Female, ages: 18 Years to any
Inclusion Criteria: * Pregnant women aged 18 years or older * Scheduled (elective) cesarean delivery, without prior onset of labor * Cesarean delivery performed under spinal anesthesia with intrathecal morphine * Single or multiple pregnancy * First or subsequent birth (nulliparous or multiparous) * Signed informed consent Exclusion Criteria: * Exteriorization of the uterus as part of the surgical technique used by the obstetrician * Severe bleeding during surgery (obstetric hemorrhage) requiring management beyond medications, such as an intrauterine balloon (Bakri balloon), hemostatic sutures (e.g., B-Lynch) or hysterectomy * Known allergy or hypersensitivity to bupivacaine, levobupivacaine or other amide-type local anesthetics * Known allergy or hypersensitivity to opioids * Myasthenia gravis * Epilepsy * Cardiac arrhythmias * Shock * Liver damage (hepatic impairment)
| Facility | City | Country | Status |
|---|---|---|---|
| Fundación Santa Fe de Bogotá | Bogotá, Bogota D.C. | Colombia |