Pain After Scheduled Cesarean Delivery: Spinal Morphine With or Without Levobupivacaine Wound Infiltration
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorFundación Santa Fe de Bogota
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Women admitted for cesarean delivery to the Obstetrics Service of Fundación Santa Fe de Bogotá, a private, high-complexity university hospital in Bogotá, Colombia, which attends approximately 2,000 births per year.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Levobupivacaine
DrugSubcutaneous 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
DrugSingle-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).
Treatment groups
336 Participants
are divided into 2 treatment groupsGroup A: Levobupivacaine wound infiltration2 interventions
Group B: No wound infiltration1 intervention
Trial outcomes
Primary outcomes
1
Postoperative pain intensity (Visual Analog Scale)
Patient-reported pain intensity on a 0 to 10 Visual Analog Scale (0 = no pain, 10 = worst imaginable pain); higher scores indicate worse pain. Self-administered through automated REDCap surveys sent by WhatsApp or email, with outcome assessors and the statistician blinded to exposure. Pain trajectories will be compared between cohorts using a linear mixed model for repeated measures (fixed effects: cohort, time and cohort-by-time interaction; patient as random effect), reporting mean between-group differences with 95% confidence intervals at each time point.
Time frame
24 hours, 48 hours and 7 days after cesarean deliverySecondary outcomes
1
Quality of obstetric recovery (ObsQoR-10 score)
Patient-reported quality of recovery measured with the validated Spanish version of the Obstetric Quality of Recovery-10 questionnaire (ObsQoR-10-Spanish). It includes 10 items scored 0 to 10, for a total score of 0 to 100; higher scores indicate better recovery. Self-administered through an automated REDCap survey. Compared between cohorts as a continuous variable.
Time frame
24 hours after cesarean delivery2
Proportion of participants with good obstetric recovery (ObsQoR-10 score ≥70)
Percentage of participants classified as having good recovery (ObsQoR-10 total score ≥70 points) versus poor recovery (\<70 points), using the cut-off reported in the literature. Compared between cohorts with risk ratios or odds ratios and 95% confidence intervals.
Time frame
24 hours after cesarean delivery3
Time to first ambulation
Time in hours from the end of cesarean delivery until the participant walks for the first time, obtained from the medical record. Compared between cohorts as a continuous variable, and with time-to-event analysis (Kaplan-Meier, log-rank test) if exact times are available.
Time frame
From end of surgery up to 24 hours after cesarean delivery4
Use of rescue analgesia
Percentage of participants who require rescue systemic opioid analgesia in addition to the standard institutional regimen (given for a pain score \>7 or at the patient's request), obtained from the medical record. Compared between cohorts with risk ratios or odds ratios and 95% confidence intervals, adjusted with multivariable logistic regression.
Time frame
First 24 hours after cesarean deliverySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: