Intrathecal Versus Epidural Morphine for Post-Cesarean Analgesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intrathecal Morphine, Epidural Morphine.
- Who it may be relevant to
- Registry conditions: Analgesia Obstetrical, Analgesia, Post Operative Pain, Patient Satisfaction. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Portugal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intrathecal Versus Epidural Morphine for Post-Cesarean Analgesia: A Randomized Controlled Trial
Overview
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.
Interventions
- Drug Intrathecal Morphine
Postoperative analgesia with intrathecal morphine 80 mcg - Drug Epidural Morphine
Postoperative analgesia with epidural morphine 2.5mg
Primary outcome measures
- Postoperative pain control [Time frame: Evaluation at 24 hours after surgery]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- Pregnant women scheduled for elective cesarean section;
- Age > 18 years;
- Willingness to participate in the study, as demonstrated by signed informed consent.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Portugal · 1 center
- Hospital Central do Funchal — Funchal
Identifiers
NCT: NCT07386353 · E24060638