Spinal-Epidural Analgesia for Labor Pain

Recruiting in Palo Alto (17 mi)

Overseen by Mrinalini Balki, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

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

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

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.

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}

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.

Trial 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 (Procedure)

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 Canada for the following indications:

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+

Dr. Anne-Claude Gingras

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Chief Executive Officer

PhD in Functional Proteomics, Canada Research Chair

Dr. Susanna Mak

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Chief Medical Officer since 2004

MD, University of Toronto

Findings from Research

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]

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]

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]