CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 229 enrolled
Drug / intervention
receiving 0.1 mg IT morphine +1 moredrug
Likely dose
receiving 0.1 mg IT morphinefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03427463
NCT03427463Early Ph 1Completed

Comparison of 0.1 and 0.05mg Intrathecal Morphine When Administered With a Multimodal Pain Regimen for Post-cesarean Analgesia

Medical University of South Carolina·interventional·Posted Feb 9, 2018·Updated Dec 19, 2024

In Brief

A Early Phase 1 clinical trial evaluating receiving 0.1 mg IT morphine and recieving 0.05 mg IT morphine for Cesarean Section. Completed, enrolled 229 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the ideal dose of spinal morphine for use in Cesarean section. Spinal anesthesia (single injection in the lower back to numb patients from the waist down) is commonly used in Cesarean section to provide numbness and pain relief during the surgery, and adding morphine to the spinal anesthetic provides long lasting pain relief for up to 24 hours after surgery. The ideal dose of spinal morphine, when given with other types of pain medications such as nonsteroidal anti-inflammatories and acetaminophen, has not been determined. In addition, spinal morphine can have side effects such as nausea and itching, so using a lower dose of morphine may decrease these side effects while providing the same amount of postoperative pain relief. Study participants will be divided into two groups. Group 1 will receive the standard dose of spinal morphine (0.1mg) while Group 2 will receive a lower dose of spinal morphine (0.05mg). Both groups will receive the standard dose of spinal bupivacaine (numbing medication) and spinal fentanyl (short acting pain medication). The additional pain medications (IV Toradol and oral acetaminophen) will be given to both groups after surgery. Pain control and morphine side effects will be compared between the two groups in order to determine the best dose of spinal morphine for cesarean section.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
201820192020202120222023202420252026
First PostedFeb 9, 2018
Enrollment StartJan 16, 2018
Primary CompletionAug 3, 2023
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 8.4 years ago

Interventions

receiving 0.1 mg IT morphinedrug

Patients will receive the standard of care dose 0.1 mg of intrathecal morphine

recieving 0.05 mg IT morphinedrug

Patients will receive 0.05 mg of intrathecal morphine