Spinal-Epidural Analgesia for Labor Pain

Overseen By Mrinalini Balki, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Disqualifiers: Spinal deformities, Back instrumentation, BMI>50, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 30 minutes

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how Combined Spinal-epidural Analgesia (CSE) affects blood flow in pregnant women during labor. CSE provides quick pain relief but may cause temporary changes in a baby's heart rate. Researchers aim to determine if these changes relate to how CSE alters blood flow in the mother and baby. They use ultrasound to study this in pregnant women in active labor who have requested pain relief, including those with pregnancy-related high blood pressure. Pregnant women in active labor with a single baby and no known complications may be suitable for this trial. As an unphased trial, the study seeks to gather insights that could enhance pain management during labor.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that combined spinal-epidural analgesia is safe for labor pain management?

Previous studies have shown that combined spinal-epidural (CSE) pain relief is about as safe as traditional epidural pain relief. Research indicates that both methods offer similar safety during labor, but CSE tends to relieve pain more quickly.

In about 15-30% of cases, CSE can cause changes in the baby's heart rate, such as a slower rate. However, these changes usually resolve on their own with little or no treatment. The exact reasons for these changes aren't fully understood, but they might relate to how CSE affects blood flow during labor.

Overall, CSE is generally well-tolerated, and its safety is comparable to that of standard epidurals, which have been used safely for many years. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial exploring spinal-epidural analgesia for labor pain because it uses ultrasound to measure the velocimetric index of the umbilical artery, which is a novel approach. Unlike traditional methods that don't involve real-time imaging, this technique could offer more precise guidance for administering analgesia, potentially enhancing both safety and effectiveness. This is particularly significant for patients with hypertensive disorders of pregnancy, where careful monitoring is crucial. By refining pain management during labor, this method could lead to better outcomes for both mothers and babies.

What evidence suggests that combined spinal-epidural analgesia is effective for labor pain?

Research has shown that combined spinal-epidural (CSE) pain relief works quickly and effectively during labor, starting faster than traditional epidurals. Studies have found that CSE often reduces pain to almost nothing, as measured by the VAS scale. This method combines the benefits of both spinal and epidural techniques, providing better pain management. While CSE offers these advantages, there is a risk of changes in the baby's heart rate, which usually return to normal on their own. Overall, CSE is a trusted option for many seeking fast and effective pain relief during labor.

In this trial, participants will be divided into two groups: one group will include patients without hypertensive disorders of pregnancy, and the other will include patients with diagnosed hypertensive disorders of pregnancy. Both groups will undergo ultrasound to measure the velocimetric index of the umbilical artery. ^{1 6 7 8 9}

Who Is on the Research Team?

Mrinalini Balki, MD

Principal Investigator

MOUNT SINAI HOSPITAL

Are You a Good Fit for This Trial?

This trial is for laboring women experiencing pain during childbirth. It's not specified who can't participate, but typically those with certain medical conditions or risks might be excluded.

Inclusion Criteria

Singleton pregnancy

Term pregnant patients in active labor

Term pregnant patients requesting labor analgesia

Exclusion Criteria

Refusal to consent for the study

Patients with BMI>50 kg/m^2 due to anticipated technical challenges in Doppler studies

I have had surgery on my back involving metal rods or screws.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Baseline velocimetric indices and pain scores are measured prior to combined spinal epidural

5 minutes

1 visit (in-person)

Treatment

Participants receive combined spinal-epidural analgesia, and velocimetric indices are measured at various intervals

30 minutes

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including fetal heart rate and maternal blood pressure

up to 24 hours

Continuous monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Combined Spinal-epidural Analgesia

Trial Overview

The study investigates how combined spinal-epidural analgesia affects blood flow in the uterine and umbilical arteries using Doppler ultrasound. The goal is to understand if this procedure impacts fetal heart rate by changing blood flow.

How Is the Trial Designed?

Group I: Ultrasound - patients without hypertensive disorders of pregnancy Experimental Treatment 1 Intervention

Ultrasound will be used to measure velocimetric index of the umbilical artery.

Group II: Ultrasound - patients with diagnosed hypertensive disorders of pregnancy Experimental Treatment 1 Intervention

Ultrasound will be used to measure velocimetric index of the umbilical artery.

Combined Spinal-epidural Analgesia is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Combined Spinal-Epidural Analgesia for:

• Labour pain relief
• Obstetric analgesia

Approved in United States as Combined Spinal-Epidural Analgesia for:

• Labour pain relief
• Obstetric analgesia

Approved in Canada as Combined Spinal-Epidural Analgesia for:

• Labour pain relief
• Obstetric analgesia

Who Is Running the Clinical Trial?

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Lead Sponsor

Trials

132

Recruited

11,400+

Published Research Related to This Trial

Combined spinal-epidural (CSE) analgesia using low-dose heavy bupivacaine without opioids resulted in significantly lower total drug consumption during labor (9.69 ml/h) compared to low-dose epidural analgesia (13.52 ml/h).

CSE also provided a faster onset of analgesia and sensory block, while both methods achieved high maternal satisfaction ratings, indicating that CSE may be a more efficient option for pain management during labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined spinal-epidural for labor analgesia with low-dose bupi- vacaine but without any opioid in the spinal component: can we improve upon the traditional? Mitra, S., Arora, J., Ahuja, V., et al.[2016]

Combined spinal-epidural (CSE) anaesthesia is a preferred method for pain relief in obstetric patients, offering the rapid onset of spinal anaesthesia along with the continuous pain management of epidural anaesthesia.

Using a combination of low doses of opioids and local anaesthetics in CSE provides effective pain relief during labor with minimal motor block, allowing for greater mobility for the mother.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Combined spinal-epidural anaesthesia for pain relief in obstetric patients]. Standl, T.[2015]

In a study involving 800 women, combined spinal-epidural (CSE) analgesia resulted in significantly lower pain scores during the first stage of labor compared to traditional epidural analgesia, indicating better pain relief.

CSE analgesia required fewer top-up doses from anesthesiologists, suggesting it may be a more efficient option for managing labor pain without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled comparison of epidural analgesia and combined spinal-epidural analgesia in a private practice setting: pain scores during first and second stages of labor and at delivery. Gambling, D., Berkowitz, J., Farrell, TR., et al.[2022]

Both epidural analgesia (EA) and combined spinal-epidural (CSE) techniques effectively relieved pain during labor, but CSE was associated with longer labor duration and mild pruritus in some mothers.

Newborns of mothers who received epidural analgesia had better neurological outcomes, with 95% showing healthy scores compared to 60% from the CSE group at the 24-hour examination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects on mother and fetus of epidural and combined spinal-epidural techniques for labor analgesia. Nakamura, G., Ganem, EM., Rugolo, LM., et al.[2019]

In a study of 144 healthy first-time mothers, initiating epidural infusion within 30 minutes after the spinal dose significantly reduced the need for additional pain relief during labor compared to starting the infusion later.

The total amount of ropivacaine used for pain management was lower in groups that started the epidural infusion sooner (within 30 minutes), suggesting that timely administration can enhance analgesic efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined spinal-epidural analgesia for labor pain: best timing of epidural infusion following spinal dose. Okutomi, T., Saito, M., Mochizuki, J., et al.[2018]

In a study of 110 healthy first-time mothers, the use of combined spinal-epidural (CSE) analgesia during labor did not significantly affect the duration of labor stages or the rates of instrumental vaginal delivery and emergency cesarean sections compared to other analgesia methods.

Neonatal outcomes, measured by Apgar scores, were similar between the CSE and non-CSE groups, indicating that CSE analgesia is safe for both mothers and their babies during labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined spinal-epidural analgesia in labour: its effects on delivery outcome. Singh, SK., Yahya, N., Misiran, K., et al.[2022]

In a study of 5247 deliveries, combined spinal-epidural (CSE) analgesia during labor was linked to increased risks of complications such as prolonged labor, higher rates of instrumental delivery, and greater blood loss.

CSE analgesia was also associated with adverse neonatal outcomes, including a higher likelihood of meconium-stained amniotic fluid and lower Apgar scores at 1 minute, indicating potential risks that should be considered when using this pain management method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivery mode and maternal and neonatal outcomes of combined spinal-epidural analgesia compared with no analgesia in spontaneous labor: A single-center observational study in Japan. Kurakazu, M., Umehara, N., Nagata, C., et al.[2020]

Combined Spinal-Epidural (CSE) analgesia provides rapid pain relief during labor without prolonging the duration of labor or affecting the mode of delivery, based on a study of 60 parturients.

CSE analgesia resulted in effective pain relief for 97% of participants, with minimal adverse effects such as pruritus and transient motor blockade, indicating it is a safe option for labor analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progress of labor and obstetric outcome in parturients with combined spinal-epidural analgesia for labor: A comparative study. Shivanagappa, M., Kumararadhya, GB., Thammaiah, SH., et al.[2022]

In a study of 110 healthy first-time mothers, the use of combined spinal-epidural (CSE) analgesia during labor did not significantly affect the duration of labor stages or the rates of instrumental vaginal delivery and emergency cesarean sections compared to those who did not receive CSE.

Neonatal outcomes, measured by Apgar scores, were similar between the CSE and non-CSE groups, indicating that CSE analgesia does not negatively impact newborn health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Combined spinal-epidural analgesia in labour: its effects on delivery outcome]. Singh, SK., Yahya, N., Misiran, K., et al.[2016]

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