Analgesia ObstetricalPhase 4NCT07386353
Intrathecal Versus Epidural Morphine for Post-Cesarean Analgesia
A Phase 4 study testing Intrathecal Morphine and Epidural Morphine in people with Analgesia Obstetrical and Analgesia, run by Hospital Central do Funchal at 1 site in Portugal.
Trial summary
Cesarean section is one of the most commonly performed surgical procedures worldwide, making effective management of acute postoperative pain a key issue in obstetric anesthesiology. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Analgesia Obstetrical, Analgesia, Post Operative Pain
- What is being tested?
- Intrathecal Morphine and Epidural Morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePortugal
- Study dates
- 20 May 2024to 31 Jul 2026
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women scheduled for elective cesarean section;
- Age > 18 years;
- Willingness to participate in the study, as demonstrated by signed informed consent.
Who cannot join
- American Society of Anesthesiologists (ASA) physical status classification > III;
- Chronic kidney disease with a glomerular filtration rate < 60 mL/min;
- Relevant drug allergies (particularly to protocol medications);
- Opioid tolerance;
- Contraindication to neuraxial anesthetic techniques.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Hospital Central do Funchal
Funchal, Madeira, 9004-514
Joao Salgado Costa, +351914633659, joaomscosta1@gmail.com
João Salgado Costa
About this study
Official title: Intrathecal Versus Epidural Morphine for Post-Cesarean Analgesia: A Randomized Controlled Trial
Cesarean section is one of the most commonly performed surgical procedures worldwide, making effective management of acute postoperative pain a key issue in obstetric anesthesiology. Post-cesarean analgesia should promote rapid maternal recovery, support newborn care, and consider the pharmacological implications for breastfeeding.
According to recent PROSPECT® guidelines from ESRA, neuraxial opioids play a central role in post-cesarean analgesia and are at least as effective as other techniques, such as continuous local anesthetic infusion. However, the optimal route of opioid administration remains unclear. While earlier studies favored epidural morphine, more recent evidence suggests that intrathecal morphine may provide superior analgesia. Due to limited and conflicting data, no definitive conclusion can be drawn. Given that epidural morphine remains standard practice at Hospital Central do Funchal, a randomized clinical trial is proposed to compare the analgesic efficacy of intrathecal versus epidural morphine after elective cesarean section.
Read the detailed description
This unicentric randomized clinical trial aims to determine whether intrathecal morphine provides superior postoperative analgesia compared with epidural morphine during the first 24 hours following cesarean section. The study population will consist of pregnant women undergoing elective cesarean delivery at Hospital Central do Funchal.
Participants will be randomly assigned to one of two groups. One group will receive postoperative analgesia with intrathecal morphine (80 mcg). The second group will receive epidural morphine, administered as a 2.5 mg bolus at the end of surgery, followed by an additional 2.5 mg bolus 24 hours postoperatively.
The primary outcome will be the assessment of pain during the first 24 postoperative hours. Secondary outcomes will include pain assessment during the first 48 hours, the need for rescue analgesia, levels of sedation, incidence of nausea and vomiting, pruritus, the impact of pain on mobilization and other activities, and overall maternal satisfaction.
- Conditions
- Analgesia Obstetrical, Analgesia, Post Operative Pain, Patient Satisfaction, Cesarean Section Pain
- Being tested
- Intrathecal Morphine, Epidural Morphine
- Keywords
- Post-Cesarean Analgesia, Epidural Morphine, Intrathecal Morphine
- Medical subject headings
- Agnosia, Pain, Postoperative, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal MorphineDrug
Postoperative analgesia with intrathecal morphine 80 mcg
Epidural MorphineDrug
Postoperative analgesia with epidural morphine 2.5mg
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal morphine | Experimental | Postoperative analgesia with intrathecal morphine 80 mcg Receives: Drug: Intrathecal Morphine |
| Epidural morphine | Experimental | Postoperative analgesia with epidural morphine 2.5mg Receives: Drug: Epidural Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain control
Comparison between intrathecal morphine versus epidural morphine analgesia assessed using the Numeric Rating Scale (NRS) as part of the PAIN OUT questionnaire.
Measured: Evaluation at 24 hours after surgery
Secondary outcomes (4)
Total rescue opioid consumption
Measured: Evaluation at 24 hours and 48 hours after surgery
Adverse effects associated with analgesia
To evaluate adverse effects associated with intrathecal versus epidural morphine administration, namely sedation, nausea, vomiting, and pruritus.
Measured: Evaluation at 24 hours and 48 hours after surgery
Patients satisfaction with analgesia
Evaluated using the satisfaction-related items of the PAIN OUT questionnaire, scored on a Numeric Rating Scale.
Measured: Evaluation at 24 hours and 48 hours after surgery
Postoperative pain control
Comparison between intrathecal morphine versus epidural morphine analgesia assessed using the Numeric Rating Scale (NRS) as part of the PAIN OUT questionnaire.
Measured: Evaluation at 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start20 May 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia ObstetricalStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Central do Funchal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joao Salgado Costa, Hospital Central do Funchal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386353
- Sponsor's protocol ID
- E24060638
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Versus Epidural Morphine for Post-Cesarean Analgesia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07386353
- Acronym / sponsor ID
- E24060638
- Conditions
- Analgesia Obstetrical, Analgesia, Post Operative Pain, Patient Satisfaction, Cesarean Section Pain
- Keywords
- Post-Cesarean Analgesia, Epidural Morphine, Intrathecal Morphine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospital Central do FunchalUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 4 Feb 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.
Cesarean section is one of the most commonly performed surgical procedures worldwide, making effective management of acute postoperative pain a key issue in obstetric anesthesiology. Post-cesarean analgesia should promote rapid maternal recovery, support newborn care, and consider the pharmacological implications for breastfeeding.
According to recent PROSPECT® guidelines from ESRA, neuraxial opioids play a central role in post-cesarean analgesia and are at least as effective as other techniques, such as continuous local anesthetic infusion. However, the optimal route of opioid administration remains unclear. While earlier studies favored epidural morphine, more recent evidence suggests that intrathecal morphine may provide superior analgesia. Due to limited and conflicting data, no definitive conclusion can be drawn. Given that epidural morphine remains standard practice at Hospital Central do Funchal, a randomized clinical trial is proposed to compare the analgesic efficacy of intrathecal versus epidural morphine after elective cesarean section.
Detailed description
This unicentric randomized clinical trial aims to determine whether intrathecal morphine provides superior postoperative analgesia compared with epidural morphine during the first 24 hours following cesarean section. The study population will consist of pregnant women undergoing elective cesarean delivery at Hospital Central do Funchal.
Participants will be randomly assigned to one of two groups. One group will receive postoperative analgesia with intrathecal morphine (80 mcg). The second group will receive epidural morphine, administered as a 2.5 mg bolus at the end of surgery, followed by an additional 2.5 mg bolus 24 hours postoperatively.
The primary outcome will be the assessment of pain during the first 24 postoperative hours. Secondary outcomes will include pain assessment during the first 48 hours, the need for rescue analgesia, levels of sedation, incidence of nausea and vomiting, pruritus, the impact of pain on mobilization and other activities, and overall maternal satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathecal morphine | Experimental | Drug: Intrathecal MorphinePostoperative analgesia with intrathecal morphine 80 mcg |
| Epidural morphine | Experimental | Drug: Epidural MorphinePostoperative analgesia with epidural morphine 2.5mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women scheduled for elective cesarean section;
- Age > 18 years;
- Willingness to participate in the study, as demonstrated by signed informed consent.
Key exclusion criteria (5 listed)
- American Society of Anesthesiologists (ASA) physical status classification > III;
- Chronic kidney disease with a glomerular filtration rate < 60 mL/min;
- Relevant drug allergies (particularly to protocol medications);
- Opioid tolerance;
- Contraindication to neuraxial anesthetic techniques.
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 |
|---|---|---|
| Intrathecal MorphinePostoperative analgesia with intrathecal morphine 80 mcg | Drug | Intrathecal morphine |
| Epidural MorphinePostoperative analgesia with epidural morphine 2.5mg | Drug | Epidural morphine |
Primary outcome
Postoperative pain control
Time frame: Evaluation at 24 hours after surgery
Comparison between intrathecal morphine versus epidural morphine analgesia assessed using the Numeric Rating Scale (NRS) as part of the PAIN OUT questionnaire.
4 secondary outcomes
Total rescue opioid consumption
Time frame: Evaluation at 24 hours and 48 hours after surgery
Adverse effects associated with analgesia
Time frame: Evaluation at 24 hours and 48 hours after surgery
Patients satisfaction with analgesia
Time frame: Evaluation at 24 hours and 48 hours after surgery
Postoperative pain control
Time frame: Evaluation at 48 hours after surgery
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 4 Feb 2026.
- Individual participant dataSharing planned: Yes
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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?
A Phase 4 study testing Intrathecal Morphine and Epidural Morphine in people with Analgesia Obstetrical and Analgesia, run by Hospital Central do Funchal at 1 site in Portugal.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 4 Feb 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 Portugal. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain control (time frame: Evaluation at 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2026.