drugset / Trial / NCT02440399

To Compare the Efficacy and Patients' Satisfaction for the Treatment of Post Cesarean Pain of Two Protocols: Oral Medications in Fixed Time Interval Administration Versus Spinal Morphine

NCT02440399 ↗

Completed 200 enrolled HaEmek Medical Center, Israel
RandomizedParallel-groupOpen-labelTreatment

Summary

Cesarean deliveries are prevalent. Unlike other operations, quick recovery is required for the mother to nurture the newborn child and establishing an appropriate mother-child bonding.

Timeline

Start
2015-07
Primary completion
2017-05
Completion
2017-05

Outcome

Missed primary endpoint

paper The oral analgesia group compared to the spinal-morphine group had similar mean pain intensity (AUC (120 ± 35 versus 121 ± 31, respectively; p = 0.8) PMID 34463805 ↗

paper but more events of moderate-to-severe breakthrough pain (4.8 ± 2 versus 3.8 ± 1.7, respectively; p = 0.0002). PMID 34463805 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 650 mg Oral
Subject Diclofenac Other / unclassified 100 mg Oral
Subject Morphine Other / unclassified 150 ug Intrathecal
Subject Tramadol Other / unclassified 75 mg Intravenous
Background Oxycodone Other / unclassified 5 mg Oral

Indications

No indication recorded.