CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
Bupivacaine-fentanyl +1 moredrug
Likely dose
Not stated in 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/NCT03117595
NCT03117595Phase 4Completed

Combined Spinal Epidural Analgesia in Labour: A Comparison of Two Intrathecal Regimens of Single Shot Spinal

Sarah Beckley·interventional·Posted Apr 18, 2017·Updated Jul 18, 2018

In Brief

A Phase 4 clinical trial evaluating Bupivacaine-fentanyl and Bupivacaine-fentanyl morphine for Labor Pain. Completed, enrolled 100 participants across 1 site.

Detailed Summary

Analgesia in labour is not readily available in many parts of Sub-Saharan Africa. The overall cost of Epidural services in terms of human personnel and financial implication makes this inaccessible to many women in labour. Thus, a cheaper, less technically demanding and easier option that can produce as much satisfaction for the parturient and would allow her participate in the second stage of labour by being able to bare down is being studied. The Single Shot Spinal (SSS) would provide pain relief in these women however its draw back is its time limitation as the option of a top up is not available. Two regimen of drug options would be considered using opioids. These would be compared to see how well they are able to provide analgesia in women who hitherto have had vaginal birth. Their onset, duration of action and possible side effects would be compared. NULL HYPOTHESIS: Single Shot Spinal with Bupivacaine Fentanyl (BF) cannot provide a statistically significant difference in labour analgesia in comparison with Bupivacaine Fentanyl Morphine (BFM) ALTERNATE HYPOTHESIS: Single Shot Spinal with BF can provide a statistically significant difference in labour in comparison with BFM

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLabor Pain
CountriesNigeria
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedApr 18, 2017
Enrollment StartNov 23, 2017
Primary CompletionFeb 27, 2018
Study CompletionApr 25, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 9.2 years ago

Interventions

Bupivacaine-fentanyldrug

Dosages as previously written

Bupivacaine-fentanyl morphinedrug

Dosage as previously written