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

Trial Summary

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 data supports the effectiveness of the treatment Combined Spinal-epidural Analgesia for labor pain?

Research shows that Combined Spinal-Epidural (CSE) analgesia is popular because it works quickly and provides reliable pain relief during labor. Studies also indicate that it can improve outcomes for both the mother and baby compared to no pain relief. ^{1 2 3 4 5}

Is combined spinal-epidural analgesia safe for labor pain management?

Combined spinal-epidural analgesia (CSE) is generally considered safe for managing labor pain, as it provides rapid and reliable pain relief. Studies have compared CSE to traditional epidural and found it to be a popular and effective alternative, with no major safety concerns reported. ^{1 2 5 6 7}

How does the treatment Combined Spinal-Epidural Analgesia (CSE) differ from other treatments for labor pain?

Combined Spinal-Epidural Analgesia (CSE) is unique because it combines the rapid onset and reliable pain relief of spinal anesthesia with the ability to adjust and prolong pain relief through continuous epidural anesthesia. This approach allows for fast pain relief and the option for the mother to walk during labor, known as a 'walking epidural', which is not typically possible with traditional epidural alone. ^{1 2 4 8 9}

What is the purpose of this trial?

Combined spinal-epidural (CSE) for labor analgesia has been used for many years and is practiced commonly at our institution, especially when the patient requests immediate pain relief. CSE is not only beneficial for its faster onset of analgesia, but also it is favorable in relation to the need for rescue analgesia, urinary retention, and rate of instrumental delivery compared to the traditional epidural. Despite its beneficial effects, there is a risk of about 15-30% of developing abnormal fetal heart rate following CSE. This is self-resolving with minimal or no intervention. Although the cause of fetal bradycardia is not fully elucidated, variations in uterine artery blood flow after epidural analgesia are thought to be due to the interaction of numerous events related to blockade of sympathetic innervations, fluid administration, maternal hypotension, uterine vascular effects of sympathetic block, fluctuations in circulating catecholamines, and possibly the effect of opioids. Similar mechanism is thought to be a cause of fetal bradycardia after the CSE with its faster onset and superior block. Maternal or fetal circulation during labor can be assessed using continuous-wave Doppler ultrasound to monitor maternal uterine artery (UtA) and fetal umbilical artery (UmA) velocity waveforms to detect changes in blood flow. The velocimetry indices mentioned above have been often used to assess the changes in the blood flow before and after the induction of epidural analgesia during labor in several studies. Although there are some studies regarding the effect of labor epidural analgesia using velocimetry indices, but there is currently no published study evaluating velocimetry indices of uterine and umbilical arteries before and after the induction of CSE. Thus, the aim of this study is to investigate the impact of CSE to maternal and fetal blood flow to evaluate the relationships. The investigators hypothesize that both uterine artery and umbilical artery blood flow are reduced after the induction of CSE, which may be responsible for the occurrence of fetal bradycardia.

Research Team

Mrinalini Balki, MD

Principal Investigator

MOUNT SINAI HOSPITAL

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

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]

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 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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

[Combined spinal-epidural analgesia in labour: its effects on delivery outcome]. [2016]

2. Brazil pubmed.ncbi.nlm.nih.gov

Combined spinal-epidural analgesia in labour: its effects on delivery outcome. [2022]

3. India pubmed.ncbi.nlm.nih.gov

Progress of labor and obstetric outcome in parturients with combined spinal-epidural analgesia for labor: A comparative study. [2022]

4. Brazil pubmed.ncbi.nlm.nih.gov

Effects on mother and fetus of epidural and combined spinal-epidural techniques for labor analgesia. [2019]

5. Australia 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. [2020]

6. Belgium 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? [2016]

7. United States 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. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

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

9. Germany pubmed.ncbi.nlm.nih.gov

Combined spinal-epidural analgesia for labor pain: best timing of epidural infusion following spinal dose. [2018]