RecruitingPhase 4NCT07386353

Intrathecal Versus Epidural Morphine for Post-Cesarean Analgesia

Intrathecal Versus Epidural Morphine for Post-Cesarean Analgesia: A Randomized Controlled Trial


Sponsor

Hospital Central do Funchal

Enrollment

120 participants

Start Date

May 20, 2024

Study Type

INTERVENTIONAL

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. 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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria3

  • Pregnant women scheduled for elective cesarean section;
  • Age > 18 years;
  • Willingness to participate in the study, as demonstrated by signed informed consent.

Exclusion Criteria5

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGIntrathecal Morphine

Postoperative analgesia with intrathecal morphine 80 mcg

DRUGEpidural Morphine

Postoperative analgesia with epidural morphine 2.5mg


Locations(1)

Hospital Central do Funchal

Funchal, Madeira, Portugal

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07386353