Pocket-warming for Epidural Anesthesia in Labor and Delivery

Phase-Based Estimates
1
Effectiveness
1
Safety
The Ohio State University Wexner Medical Center, Columbus, OH
Pocket-warming - Other
Eligibility
18+
Female
Eligible conditions
Epidural Anesthesia in Labor and Delivery

Study Summary

This study is evaluating whether warming epidural medications may help reduce the length of labor.

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether Pocket-warming will improve 1 primary outcome and 4 secondary outcomes in patients with Epidural Anesthesia in Labor and Delivery. Measurement will happen over the course of duration of labor and delivery.

Delivery
Mode of delivery
duration of labor and delivery
Time until pain score less than or equal to 3
during labor
Breakthrough pain
during labor and delivery
Vital Signs
first hour of epidural administration
Labor analgesia satisfaction

Trial Safety

Trial Design

2 Treatment Groups

Room-temperature epidural medication
Pocket-warmed epidural medication

This trial requires 150 total participants across 2 different treatment groups

This trial involves 2 different treatments. Pocket-warming is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Pocket-warmed epidural medication
Other
This arm will consist of pocket-warmed epidural medications to be administered per standard protocol to patients randomized to this group; this group is the pocket-warming group.
Room-temperature epidural medication
Other
This arm will consist of room-temperature epidural medications to be administered per standard protocol to patients randomized to this group. This group has no experimental intervention; standard of care labor epidural.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: first hour of epidural administration
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly first hour of epidural administration for reporting.

Who is running the study

Principal Investigator
L. H.
Prof. Ling-Qun Hu, Professor-Clinical, Anesthesiology
Ohio State University

Closest Location

The Ohio State University Wexner Medical Center - Columbus, OH

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
do not need to undergo cesarean section Cesarean section is not necessary for women with a single vertex presentation fetus at term. show original
are predictors of spontaneous passage show original
I would like to have an epidural for labor analgesia, please. show original
I give my consent to participate in this study. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of epidural anesthesia in labor and delivery?

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The epidural placement in labor is associated with a reduction of opioid requirement and incidence of episiotomy. But there is a need to have a large cohort study to confirm these findings.

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What are common treatments for epidural anesthesia in labor and delivery?

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The current study shows no important adverse effects of epidural anesthesia except for the high incidence of hypotension during the first and a few minutes after the epidural injection.

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What is epidural anesthesia in labor and delivery?

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The use of epidural anesthesia for labor, in selected women, may improve postpartum analgesia and increase the patient's comfort compared with spinal anesthesia. Because of conflicting results from several trials, conclusions regarding the relative effectiveness of epidural versus spinal anesthesia could not be definitely made. Epidural anesthesia in labor is still a controversial topic, particularly when it comes to the risks of the procedure.

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What causes epidural anesthesia in labor and delivery?

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There is a marked increase in the incidence of epidural anesthesia with a gradual decrease in the overall anesthetic use in the period of 2000-2004 when compared to the period of 1990-1999. Some risk factors like anesthetic status, previous cesarean section, epidural gel misuse, anesthesia training, and duration of delivery are not associated with epidural anesthesia.

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Can epidural anesthesia in labor and delivery be cured?

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Epidural anesthesia in labor and delivery can not be cured, because of the pain relief it brings. It is also unnecessary, and it causes significant adverse risks and cost.

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How many people get epidural anesthesia in labor and delivery a year in the United States?

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There were roughly 605,000 epidural procedures performed during labor and delivery in the United States in 2003. Over 5 years a total of 705,000 labors and 589,000 deliveries were accompanied by epidural anesthesia in America. Of all epidural procedures performed, only 6% were indicated and 93% were for labor management and delivery. There were approximately 16,000 unplanned epidural anesthesia requirements. All of these data are in accordance with current medical knowledge.

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What is pocket-warming?

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The pocket-warming intervention had little impact on the delivery mode. Pouch and perineum temperature, both measured pre-intervention and post-intervention, was similar between the intervention and control group.

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Have there been other clinical trials involving pocket-warming?

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The majority of doctors consider using a pocket-warming wrap in parturients undergoing regional analgesia for labor pain, but they seldom use it in clinical practice. The use of a pocket-warming wrap is supported by the majority of labor practitioners; however, the use is not supported by all labor practitioners. While the authors would urge caution in recommending blanket use of a pocket-warming wrap, they recommend the use of a pocket-warming wrap in parturients undergoing regional labor analgesia for labor pain.

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Does epidural anesthesia in labor and delivery run in families?

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Epidural anesthesia is more frequently initiated in cases requiring epidural analgesia, regardless of race or socioeconomic background. As a result, it could be speculated that racial and socioeconomic differences in epidural use in labor and delivery operate independently of family history.

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What is the primary cause of epidural anesthesia in labor and delivery?

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The use of local anesthetics for epidural analgesia during labor may lead to clinically important epidural block in approximately 30-50% of cases. It is also difficult to predict the likelihood of epidural block occurring. Thus, patient education and discussion about this risk should be part of the routine education given to couples planning to give birth in an inpatient setting.

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How serious can epidural anesthesia in labor and delivery be?

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Epidural, with both peripheral anesthesia and general anesthesia used, is safer than epidural under spinal anesthesia in labor and delivery. The risk of life-threatening complications was significantly lower when epidural anesthesia was used without general anesthesia.

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What does pocket-warming usually treat?

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There is wide variation in the definition of what pocket warming does. It has been used traditionally by obstetricians as well as anaesthesiologists to lower the temperatures around the maternal skin during labour to help decrease shivering. It has also been shown to decrease postdelivery shivering by up to 50%. Pocket-warming, however, is not recommended for the purpose of preventing or reducing shivering in the mother after delivery, because it only causes slight increases and is not considered cost-effective or useful. It might be useful as part of a multi-modal regimen, such as warming the mother in more conventional ways.

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