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Completed

NCT Number: NCT03117595

CSE for Labour Analgesia: A Comparison of Two Intrathecal Regimens

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

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Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Lagos Island Maternity Centre

Lagos, Nigeria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine-fentanyl

Drug

Dosages as previously written

Bupivacaine-fentanyl morphine

Drug

Dosage as previously written

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sarah Beckley

Other

Registry information

Official study title

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

Acronym: SSS

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 18, 2017
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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