Clinical trial NCT02912078: Pocket Warming of Epidural Medication
Official title: Pocket Warming of Epidural Medication to Shorten Onset of Labor Analgesia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Epidural Anesthesia in Labor and Delivery
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Women with a single vertex presentation fetus at term (38-42 weeks)
2. Intact fetal membranes or membrane rupture \<6 hours previously
3. Request to have an epidural for labor analgesia
4. Provide written consent for the study.

Exclusion Criteria:

1. Patients being treated/managed for chronic pain
2. Allergies or significant adverse reactions to local anesthetic or opioid medications
3. Contraindication to labor epidural placement
4. Patients with history of spine abnormalities or spine surgery
5. Clinical signs or symptoms of infection
6. Baseline temperature \> 37.6 °C
7. Non-English speaking
8. Prisoners
9. Age less than 18 years old

Primary outcomes:
measure: Time until pain score less than or equal to 3
timeFrame: duration of labor and delivery
Secondary outcomes:
measure: Labor analgesia satisfaction
timeFrame: first hour of epidural administration
measure: Vital Signs
timeFrame: during labor and delivery
measure: Breakthrough pain
timeFrame: during labor
measure: Mode of delivery
timeFrame: Delivery
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: John Coffman, MD
role: PRINCIPAL_INVESTIGATOR
References: