Pain ManagementLEVO-CSNCT07859956
Pain After Scheduled Cesarean Delivery: Spinal Morphine With or Without Levobupivacaine Wound Infiltration
An observational study of Pain Management and C Section, run by Fundación Santa Fe de Bogota at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain Management, C Section, Obstetric Pain
- What is being tested?
- Levobupivacaine and Intrathecal Morphine
- Type of treatment
- Injection or infusion
- How many people
- 336 participants
- Where
- 1 siteColombia
- Study dates
- 14 Oct 2026to 14 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Cardiac arrhythmias
- Shock
- Liver damage (hepatic impairment)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site
Fundación Santa Fe de Bogotá
Bogotá, Bogota D.C., 111321
Karen D Cepeda, MD, +573173691828, investigador.gorh@fsfb.org.co
Camilo Hernandez, MD, +573153891355, chernandezdea@hotmail.com
About this study
Official title: Postoperative Pain Control After Cesarean Delivery: Intrathecal Morphine With or Without Adjunctive Fascial Levobupivacaine Infiltration. A Prospective Observational Cohort Study
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:
Read more
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.
Read the detailed description
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.
- Conditions
- Pain Management, C Section, Obstetric Pain, Levobupivacaine
- Being tested
- Levobupivacaine, Intrathecal Morphine
- Keywords
- Cesarean Section, Pain, Postoperative, Levobupivacaine, Analgesia, Obstetrical, Pain Management
- Medical subject headings
- Agnosia, Labor Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Also called Bupinest®, Levobupivacaine hydrochloride
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 MorphineDrug
Also called Spinal 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).
| Study group | Role | What they receive |
|---|---|---|
| Levobupivacaine wound infiltration | 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. Receives: Drug: Levobupivacaine; Drug: Intrathecal Morphine | |
| No wound infiltration | 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. Receives: Drug: Intrathecal Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours, 48 hours and 7 days after cesarean delivery
Secondary outcomes (4)
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.
Measured: 24 hours after cesarean delivery
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.
Measured: 24 hours after cesarean delivery
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.
Measured: From end of surgery up to 24 hours after cesarean delivery
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.
Measured: First 24 hours after cesarean delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start14 Oct 2026 (estimated)
- Primary completion14 Jul 2027 (estimated)
- Study completion14 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Santa Fe de Bogota
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camilo Hernandez de Alba, Fundación Santa Fe de Bogota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859956
- Sponsor's protocol ID
- 20493-2026
- Acronym
- LEVO-CS
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- No: Individual participant data will not be shared outside the research team, as the informed consent approved by the institutional ethics committee does not include authorization for data sharing with external researchers. Data will be stored confidentially in the institutional REDCap platform of Fundación Santa Fe de Bogotá for at least 5 years. Aggregated results will be published regardless of direction.
Publications
Garmi G, et al. Efficacy of single wound infiltration with bupivacaine and adrenaline during cesarean delivery for reduction of postoperative pain: a randomized clinical trial. JAMA Netw Open. 2022;5(11):e2242203. doi:10.1001/jamanetworkopen.2022.42203 Roofthooft E, et al. PROSPECT guideline for elective caesarean section: updated systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021;76(5):665-680. doi:10.1111/anae.15339 Sultan P, Monks DT, Sharawi N, et al. Guidelines for postoperative care in cesarean delivery: Enhanced Recovery After Surgery Society recommendations (part 3). Am J Obstet Gynecol. doi:10.1016/j.ajog.2025.01.038 Sultan P, et al. Evaluation of inpatient postpartum recovery using the Obstetric Quality of Recovery-10 patient-reported outcome measure: a single-center observational study. Am J Obstet Gynecol MFM. 2020;2(4):100202. doi:10.1016/j.ajogmf.2020.100202 Guevara J, et al. Development and validation of a Spanish version of the Obstetric Quality of Recovery-10 item score (ObsQoR-10-Spanish). BJA Open. 2024;10:100269. doi:10.1016/j.bjao.2024.100269 Niklasson B, et al. Intraoperative injection of bupivacaine-adrenaline close to the fascia reduces morphine requirements after cesarean section: a randomized controlled trial. Acta Obstet Gynecol Scand. 2012;91(12):1433-1439. doi:10.1111/j.1600-0412.2012.01480.x
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Control After Cesarean Delivery: Intrathecal Morphine With or Without Adjunctive Fascial Levobupivacaine Infiltration. A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07859956
- Acronym / sponsor ID
- LEVO-CS / 20493-2026
- Conditions
- Pain Management, C Section, Obstetric Pain, Levobupivacaine
- Keywords
- Cesarean Section, Pain, Postoperative, Levobupivacaine, Analgesia, Obstetrical, Pain Management
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Fundación Santa Fe de BogotaUniversity, hospital or other
- Study start
- 14 Oct 2026 (estimated)
- Primary completion
- 14 Jul 2027 (estimated)
- Study completion
- 14 Sep 2027 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levobupivacaine wound infiltration | – | Drug: Levobupivacaine, Drug: Intrathecal MorphineWomen 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 MorphineWomen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevobupivacaineAlso: Bupinest®, Levobupivacaine hydrochlorideSubcutaneous 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. | Drug | Levobupivacaine wound infiltration |
| Intrathecal MorphineAlso: Spinal morphineSingle-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). | Drug | Levobupivacaine wound infiltration, No wound infiltration |
Primary outcome
Postoperative pain intensity (Visual Analog Scale)
Time frame: 24 hours, 48 hours and 7 days after cesarean delivery
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.
4 secondary outcomes
Quality of obstetric recovery (ObsQoR-10 score)
Time frame: 24 hours after cesarean delivery
Proportion of participants with good obstetric recovery (ObsQoR-10 score ≥70)
Time frame: 24 hours after cesarean delivery
Time to first ambulation
Time frame: From end of surgery up to 24 hours after cesarean delivery
Use of rescue analgesia
Time frame: First 24 hours after cesarean delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- BackgroundGarmi G, et al. Efficacy of single wound infiltration with bupivacaine and adrenaline during cesarean delivery for reduction of postoperative pain: a randomized clinical trial. JAMA Netw Open. 2022;5(11):e2242203. doi:10.1001/jamanetworkopen.2022.42203 Roofthooft E, et al. PROSPECT guideline for elective caesarean section: updated systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021;76(5):665-680. doi:10.1111/anae.15339 Sultan P, Monks DT, Sharawi N, et al. Guidelines for postoperative care in cesarean delivery: Enhanced Recovery After Surgery Society recommendations (part 3). Am J Obstet Gynecol. doi:10.1016/j.ajog.2025.01.038 Sultan P, et al. Evaluation of inpatient postpartum recovery using the Obstetric Quality of Recovery-10 patient-reported outcome measure: a single-center observational study. Am J Obstet Gynecol MFM. 2020;2(4):100202. doi:10.1016/j.ajogmf.2020.100202 Guevara J, et al. Development and validation of a Spanish version of the Obstetric Quality of Recovery-10 item score (ObsQoR-10-Spanish). BJA Open. 2024;10:100269. doi:10.1016/j.bjao.2024.100269 Niklasson B, et al. Intraoperative injection of bupivacaine-adrenaline close to the fascia reduces morphine requirements after cesarean section: a randomized controlled trial. Acta Obstet Gynecol Scand. 2012;91(12):1433-1439. doi:10.1111/j.1600-0412.2012.01480.x
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside the research team, as the informed consent approved by the institutional ethics committee does not include authorization for data sharing with external researchers. Data will be stored confidentially in the institutional REDCap platform of Fundación Santa Fe de Bogotá for at least 5 years. Aggregated results will be published regardless of direction.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Management and C Section, run by Fundación Santa Fe de Bogota at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen D Cepeda, MD (+573173691828, investigador.gorh@fsfb.org.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity (Visual Analog Scale) (time frame: 24 hours, 48 hours and 7 days after cesarean delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07859956, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.