Hospital Central do Funchal
Funchal, Madeira, 9004-514, Portugal
Location status: Recruiting
Location contact
Joao Salgado Costa
CONTACT
João Salgado Costa
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07386353
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Phase 4
Funchal, Madeira, 9004-514, Portugal
Location status: Recruiting
Joao Salgado Costa
CONTACT
João Salgado Costa
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Postoperative analgesia with intrathecal morphine 80 mcg
Postoperative analgesia with epidural morphine 2.5mg
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.
Time frame: Evaluation at 24 hours and 48 hours after surgery
Time frame: Evaluation at 24 hours and 48 hours after surgery
To evaluate adverse effects associated with intrathecal versus epidural morphine administration, namely sedation, nausea, vomiting, and pruritus.
Time frame: Evaluation at 24 hours and 48 hours after surgery
Evaluated using the satisfaction-related items of the PAIN OUT questionnaire, scored on a Numeric Rating Scale.
Time frame: Evaluation at 48 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.
Hospital Central do Funchal
Other
Intrathecal Versus Epidural Morphine for Post-Cesarean Analgesia: A Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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