CSE for Labour Analgesia: A Comparison of Two Intrathecal Regimens

Status Completed

Clinical Trial 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

Clinical Trial Description

A double blinded randomized study comparing 2 intrathecal mixtures for labour analgesia.

94 multiparous parturients in active labour who have given informed consent would be recruited into the study. They would be randomly allocated into 2 groups using simple random sampling. An Assistant would know the code and prepare the intrathecal solutions.

Baseline vitals would be taken and patient's pain score noted. Due protocol would be followed and a combined spinal epidural sited but with the epidural not activated until the effect of the spinal wears off.

Routine monitoring would be done and various parameters and indices noted. Where the effect of the spinal lasts the duration of labour thus no need to activate the epidural, this would also be noted.

Data would be analysed using Statistical Package of Social Sciences (SPSS) version 20. ;

Study Design

Related Conditions & MeSH terms

Labor Pain

Clinical Trial Details

NCT number	NCT03117595
Study type	Interventional
Source	Lagos State Health Service Commission
Contact
Status	Completed
Phase	Phase 4
Start date	November 23, 2017
Completion date	April 25, 2018

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See also
Status	Clinical Trial	Phase
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Completed	`NCT02885350` - Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour	Phase 4
Completed	`NCT02550262` - Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor	N/A
Completed	`NCT01598506` - Intrathecal Hydromorphone for Labor Analgesia	Phase 2
Withdrawn	`NCT01636999` - Comparing Sedara to Butorphanol in Early Labor	N/A
Completed	`NCT00987441` - Epidural Labor Analgesia and Infant Neurobehavior	N/A
Completed	`NCT00755092` - Effect of Doula in Nulliparas and Multiparas	N/A
Terminated	`NCT00787176` - The Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes	N/A
Recruiting	`NCT06036797` - Efficacy and Safety of Hydromorphone-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia	Phase 2
Completed	`NCT05512065` - Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women	N/A
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Completed	`NCT03103100` - Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation	Phase 3
Recruiting	`NCT03623256` - Comparison of Intrathecal Versus Epidural Fentanyl on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia	Phase 4
Active, not recruiting	`NCT02271100` - Assessment of the Use of Ultrasound for Epidural Catheter Placement and Comparison With Palpation Technique	N/A
Completed	`NCT02926469` - Virtual Reality Analgesia in Labor: The VRAIL Pilot Study	N/A
Completed	`NCT03712735` - Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women	Phase 4
Not yet recruiting	`NCT05565274` - Outcome of Combined Tramadol and Paracetamol Versus Pentazocine as Labour Analgesia Among Parturients	N/A
Recruiting	`NCT02575677` - Oxycodone in Treatment of Early Labour Pain Efficacy and Safety
Recruiting	`NCT01708668` - The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

CSE for Labour Analgesia: A Comparison of Two Intrathecal Regimens — SSS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms