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

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ClinicalTrials.gov Identifier: NCT03117595
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Sarah Beckley, Lagos State Health Service Commission

Brief 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


Condition or disease Intervention/treatment Phase
Labor Pain Drug: Bupivacaine-fentanyl Drug: Bupivacaine-fentanyl morphine Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 groups that would remain with the randomly picked intervention throughout the study duration
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: a double blinded study. The participant and the Physician giving the treatment who would also evaluate the participant during the duration of the study are masked. However, the Assistant who is in charge of the randomization process and has the code and so would prepare the drugs is not blinded. The non-blinded Assistant would be available to break the code in the event of any adverse reactions.
Primary Purpose: Treatment
Official Title: Combined Spinal Epidural Analgesia in Labour: A Comparison of Two Intrathecal Regimens of Single Shot Spinal
Actual Study Start Date : November 23, 2017
Actual Primary Completion Date : February 27, 2018
Actual Study Completion Date : April 25, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: BF
Interventions: Intrathecal administration -Bupivacaine 2.5mg (0.5ml) + Fentanyl 25mcg (0.5ml) + 1ml sterile water in one shot Ephedrine 3-5mg in aliquots in the event of hypotension Promethazine 12.5 - 25mg in the event of vomiting or significant pruritus naloxone 2mcg/kg in the event of respiratory distress
Drug: Bupivacaine-fentanyl
Dosages as previously written

Active Comparator: BFM
Interventions: Intrathecal administration - Bupivacaine 2.5mg (0.5ml) + fentanyl 25mcg (0.5ml) + 0.25mg morphine (0.25ml) + 0.75ml sterile water in one shot ephedrine 3-5mg in aliquots for hypotension Promethazine 12.5 - 25mg for vomiting or significant pruritus Naloxone 2mcg/kg in the event of respiratory distress
Drug: Bupivacaine-fentanyl morphine
Dosage as previously written




Primary Outcome Measures :
  1. Time to First painless contraction (TFC) [ Time Frame: time zero to first painless contraction estimated 15 minutes ]
    This is the onset of action of the drugs. The time duration from the initiation of the block at time zero to the point where there is significant drop in the Numerical Rating Scale (NRS) to 2 or less

  2. Time to First Request for Analgesia (TFA) [ Time Frame: Time zero till NRS > 6 estimated 180 minutes ]
    This is the duration of action of the block. Time from initiation of the block to time the pain score is up to 6 or more. It is expected that after onset of the block (TFC) the pain would first become negligible or absent and after a period of time, it would gradually increase as the drug wears off. If the pain becomes moderate at a NRS of 6 or the patient requests for analgesia, the time would be noted and the epidural would be activated.


Secondary Outcome Measures :
  1. Delivery before TFA or delivery after TFA [ Time Frame: duration of labour estimated 180 minutes ]
    Qualitative variable. determines if rescue analgesia was needed (if the epidural needed to be activated) or if the spinal was adequate for the duration of labour

  2. Maternal Satisfaction [ Time Frame: up to 300 minutes ]
    Parturients perception of if analgesia was Adequate, Inadequate or Not Sure

  3. Side effects [ Time Frame: up to 180 minutes ]
    Presence of side effects like respiratory depression, pruritus, or vomiting



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Parturients in active labour >4cm dilatation
  • American Society of Anesthesiologists (ASA) classification I and II

Exclusion Criteria:

  • Significant co-morbidities like uncontrolled hypertension or diabetes
  • Maternal hemorrhage with hypotension
  • Significant bleeding/clotting disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03117595


Locations
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Nigeria
Lagos Island Maternity Centre
Lagos, Nigeria
Sponsors and Collaborators
Sarah Beckley
Investigators
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Study Chair: Olaniyi Oladapo, MBBS,FMCA, FWACS School of Anaesthetic Studies, Health Service Commission, Lagos State

Publications:
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Responsible Party: Sarah Beckley, Senior Registrar and Diplomate, Dept of Anaesthesia, General Hospital, Gbagada Lagos, Nigeria, Lagos State Health Service Commission
ClinicalTrials.gov Identifier: NCT03117595    
Other Study ID Numbers: SAS/17/03
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sarah Beckley, Lagos State Health Service Commission:
Single Shot Spinal
Intrathecal narcotics
Morphine
Fentanyl
Labour Analgesia
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Fentanyl
Morphine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General