Epidural Anesthesia in Labor and DeliveryNCT02912078
Pocket Warming of Epidural Medication
A study testing Pocket-warming in people with Epidural Anesthesia in Labor and Delivery, run by Ohio State University at 1 site in United States.
Trial summary
This study will examine recent claims regarding the beneficial effect of warming epidural medications in order to hasten the onset of labor analgesia. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Epidural Anesthesia in Labor and Delivery
- What is being tested?
- Pocket-warming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2024to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with a single vertex presentation fetus at term (38-42 weeks)
- Intact fetal membranes or membrane rupture <6 hours previously
- Request to have an epidural for labor analgesia
- Provide written consent for the study.
Who cannot join
- Patients being treated/managed for chronic pain
- Allergies or significant adverse reactions to local anesthetic or opioid medications
- Contraindication to labor epidural placement
- Patients with history of spine abnormalities or spine surgery
- Clinical signs or symptoms of infection
- Baseline temperature > 37.6 °C
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- Non-English speaking
- Prisoners
- Age less than 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: Pocket Warming of Epidural Medication to Shorten Onset of Labor Analgesia
This study will examine recent claims regarding the beneficial effect of warming epidural medications in order to hasten the onset of labor analgesia.
Read the detailed description
Studies have shown that warmed epidural medication resulted in a mean analgesic onset of 9.2 minutes as compared to a mean onset of 16 minutes for the same medication at room temperature. Onset time for pain medication during labor is important to a great many participants, thus techniques to shorten analgesic onset are relevant to daily clinical practice. Combined-spinal epidural (CSE) techniques have been used to improve the onset and reliability of labor analgesia compared to epidural techniques; however, CSEs have risks associated with their usage. Firstly, is not always possible to administer a spinal dose despite successful loss-of resistance with CSE techniques, providing less satisfactory labor analgesia, and secondly, the CSE technique has been associated with a greater incidence of non-reassuring fetal heart tones (FHT), uterine hyperactivity, maternal pruritis, and greater incidence of neurologic sequelae compared to epidural analgesia. Further, CSE labor analgesia is more likely to result in prolonged FHT decelerations if there is FHT abnormalities prior to the neuraxial procedure. Given these potential limitations of CSE techniques for labor analgesia, epidural medication warming may represent an effective alternative for safe and satisfactory labor analgesia.
Previous studies in obstetric and non-obstetric patients undergoing surgery have demonstrated a more rapid onset of sensory blockade in patients receiving body temperature (37 °C) epidural medication compared to room temperature medication, though other reports have found no significant difference in the onset of sensory blockade when comparing body temperature to room temperature epidural medications. To the knowledge of the investigators, there are few studies examining the effect of warmed epidural medications for patients receiving epidural labor analgesia.
In the experience of the investigators' colleagues, the close proximity to the body has a warming effect on the epidural medication and ultimately leads to quicker onset of pain relief once administered. Pocket warming does not warm the medications to the same extent as an incubator, but is certainly less expensive and is readily available to every obstetric anesthesia practice.
The investigators have previously measured the temperature of five 10mL syringes of normal saline at room temperature and at baseline the average was 21.7 °C (range 21.5-21.9 °C), and increased to an average of 29.7 °C (range 29.1 - 30.2 °C) after 1.5 hours of pocket warming. It has not been studied and is unknown if this degree of warming would be effective in enhancing the onset of labor analgesia, but such information is valuable given that an approximate 30 °C temperature may be accomplished by simple pocket warming and is within manufacturer recommended storage temperatures of 15-30 °C.
The investigators also assessed the potential for epidural medication cooling by measuring the temperature of one of the investigator's 10mL saline syringes for twenty minutes after removal from the warm pocket environment. The initial temperature of 30.0 °C had cooled to 27.0 °C by five minutes, 24.7 °C by ten minutes, 22.9 °C by fifteen minutes, and had returned to baseline room temperature by twenty minutes. The time between medication removal and dosing is important to consider given that significant cooling may occur and negate any potential benefits of warming the medication. This cooling effect makes use of a centralized warmer less promising, as it could take 10-20 minutes to position the patient and complete placement of the epidural catheter prior to dosing the medication. The use of a bedside incubator or a pocket warming technique would be useful in this regard, because the medication could be administered immediately after removal from the warm environment.
The investigators hypothesize that pocket warming in the front, upper pocket would be beneficial in enhancing onset of labor analgesia relative to room temperature medication.
- Being tested
- Pocket-warming, Standard of Care Labor Epidural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pocket-warmingOther
Pocket-warming of epidural medication
Standard of Care Labor EpiduralOther
Labor epidural medication administered per standard of care; no pocket warming.
| Study group | Role | What they receive |
|---|---|---|
| Pocket-warmed epidural medication | Experimental | 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. Receives: Other: Pocket-warming |
| Room-temperature epidural medication | Active comparator | 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. Receives: Other: Standard of Care Labor Epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until pain score less than or equal to 3
Assess pain level regularly during labor
Measured: duration of labor and delivery
Secondary outcomes (4)
Labor analgesia satisfaction
Patients will assess initiation of labor analgesia using a 1-100 point rating scale at their routine follow-up visit.
Measured: first hour of epidural administration
Vital Signs
oral temperature, fever (temperature greater than 38 °C), nausea, vomiting, shivering, and blood pressure will be measured during the first 60 minutes of labor analgesia. Fever at any time during labor will be recorded.
Measured: during labor and delivery
Breakthrough pain
number of required rescue epidural boluses, time until first manual epidural rescue bolus, and total number of manual anesthetic interventions to treat inadequate labor analgesia will be recorded during labor
Measured: during labor
Mode of delivery
Mode of delivery will be recorded (i.e. cesarean, spontaneous vaginal or instrumental vaginal delivery)
Measured: Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study start30 Sep 2024
- Primary completion31 Dec 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural Anesthesia in Labor and DeliveryStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- we propose to conduct a prospective, randomized controlled trial to compare the initiation of labor with room temperature epidural medication (pharmacy-prepared 0.125% Bupivacaine with Fentanyl 2mcg/ml - 10mL) to the same epidural medication that has been pocket warmed for a minimum of 1 hour
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling-Qun Hu, Ohio State University
- Investigators
- John Coffman, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912078
- Sponsor's protocol ID
- 2016H0153
- Status last verified
- Feb 2026
- First submitted
- 2 May 2016
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pocket Warming of Epidural Medication to Shorten Onset of Labor Analgesia
- ClinicalTrials.gov ID
- NCT02912078
- Acronym / sponsor ID
- 2016H0153
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 23 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine recent claims regarding the beneficial effect of warming epidural medications in order to hasten the onset of labor analgesia.
Detailed description
Studies have shown that warmed epidural medication resulted in a mean analgesic onset of 9.2 minutes as compared to a mean onset of 16 minutes for the same medication at room temperature. Onset time for pain medication during labor is important to a great many participants, thus techniques to shorten analgesic onset are relevant to daily clinical practice. Combined-spinal epidural (CSE) techniques have been used to improve the onset and reliability of labor analgesia compared to epidural techniques; however, CSEs have risks associated with their usage. Firstly, is not always possible to administer a spinal dose despite successful loss-of resistance with CSE techniques, providing less satisfactory labor analgesia, and secondly, the CSE technique has been associated with a greater incidence of non-reassuring fetal heart tones (FHT), uterine hyperactivity, maternal pruritis, and greater incidence of neurologic sequelae compared to epidural analgesia. Further, CSE labor analgesia is more likely to result in prolonged FHT decelerations if there is FHT abnormalities prior to the neuraxial procedure. Given these potential limitations of CSE techniques for labor analgesia, epidural medication warming may represent an effective alternative for safe and satisfactory labor analgesia.
Previous studies in obstetric and non-obstetric patients undergoing surgery have demonstrated a more rapid onset of sensory blockade in patients receiving body temperature (37 °C) epidural medication compared to room temperature medication, though other reports have found no significant difference in the onset of sensory blockade when comparing body temperature to room temperature epidural medications. To the knowledge of the investigators, there are few studies examining the effect of warmed epidural medications for patients receiving epidural labor analgesia.
In the experience of the investigators' colleagues, the close proximity to the body has a warming effect on the epidural medication and ultimately leads to quicker onset of pain relief once administered. Pocket warming does not warm the medications to the same extent as an incubator, but is certainly less expensive and is readily available to every obstetric anesthesia practice.
The investigators have previously measured the temperature of five 10mL syringes of normal saline at room temperature and at baseline the average was 21.7 °C (range 21.5-21.9 °C), and increased to an average of 29.7 °C (range 29.1 - 30.2 °C) after 1.5 hours of pocket warming. It has not been studied and is unknown if this degree of warming would be effective in enhancing the onset of labor analgesia, but such information is valuable given that an approximate 30 °C temperature may be accomplished by simple pocket warming and is within manufacturer recommended storage temperatures of 15-30 °C.
The investigators also assessed the potential for epidural medication cooling by measuring the temperature of one of the investigator's 10mL saline syringes for twenty minutes after removal from the warm pocket environment. The initial temperature of 30.0 °C had cooled to 27.0 °C by five minutes, 24.7 °C by ten minutes, 22.9 °C by fifteen minutes, and had returned to baseline room temperature by twenty minutes. The time between medication removal and dosing is important to consider given that significant cooling may occur and negate any potential benefits of warming the medication. This cooling effect makes use of a centralized warmer less promising, as it could take 10-20 minutes to position the patient and complete placement of the epidural catheter prior to dosing the medication. The use of a bedside incubator or a pocket warming technique would be useful in this regard, because the medication could be administered immediately after removal from the warm environment.
The investigators hypothesize that pocket warming in the front, upper pocket would be beneficial in enhancing onset of labor analgesia relative to room temperature medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- we propose to conduct a prospective, randomized controlled trial to compare the initiation of labor with room temperature epidural medication (pharmacy-prepared 0.125% Bupivacaine with Fentanyl 2mcg/ml - 10mL) to the same epidural medication that has been pocket warmed for a minimum of 1 hour
| Arm | Type | Receives |
|---|---|---|
| Pocket-warmed epidural medication | Experimental | Other: Pocket-warmingThis 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 | Active comparator | Other: Standard of Care Labor EpiduralThis 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women with a single vertex presentation fetus at term (38-42 weeks)
- Intact fetal membranes or membrane rupture <6 hours previously
- Request to have an epidural for labor analgesia
- Provide written consent for the study.
Key exclusion criteria (9 listed)
- Patients being treated/managed for chronic pain
- Allergies or significant adverse reactions to local anesthetic or opioid medications
- Contraindication to labor epidural placement
- Patients with history of spine abnormalities or spine surgery
- Clinical signs or symptoms of infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pocket-warmingPocket-warming of epidural medication | Other | Pocket-warmed epidural medication |
| Standard of Care Labor EpiduralLabor epidural medication administered per standard of care; no pocket warming. | Other | Room-temperature epidural medication |
Primary outcome
Time until pain score less than or equal to 3
Time frame: duration of labor and delivery
Assess pain level regularly during labor
4 secondary outcomes
Labor analgesia satisfaction
Time frame: first hour of epidural administration
Vital Signs
Time frame: during labor and delivery
Breakthrough pain
Time frame: during labor
Mode of delivery
Time frame: Delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Coffman, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pocket-warming in people with Epidural Anesthesia in Labor and Delivery, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time until pain score less than or equal to 3 (time frame: duration of labor and delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.