PainPhase 2NCT02020304
Combined Spinal-Epidural Temperature and Duration of Action
A Phase 2 study testing combined spinal epidural in people with Pain, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The hypothesis is that a combined spinal-epidural drug at refrigerated temperature will have a shorter period of pain relief than that maintained at room temperature. The temperature of the dose of medication will be measure with an infrared thermometer immediately prior (within 5 minutes) to administration. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- combined spinal epidural
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2013to 4 May 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- >/= 18 years of age not allergic to medications used to treat labor pain </= 6cm cervical dilation visual pain score >/=3
Who cannot join
- <18 years of age > 6 cm cervical dilation non-English speaking subjects
Trial locations and contacts
1 site in 1 country.
United States1 site
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
About this study
Official title: Effect of Temperature of Combined Spinal Epidural Dosing on Duration
The hypothesis is that a combined spinal-epidural drug at refrigerated temperature will have a shorter period of pain relief than that maintained at room temperature. The temperature of the dose of medication will be measure with an infrared thermometer immediately prior (within 5 minutes) to administration.
Read the detailed description
Subjects will receive a combined spinal epidural medication as per standard of care to treat their labor pain; however, they will be randomized to receive either a dose maintained at room temperature (60-75 degrees F) or one maintained in a refrigerator (~<43 degrees F). Duration of action will be done by assessments of pain, vital signs, nausea, itching, bromage and fetal heart rate every 15 minutes until the subject requests additional pain medication to treat their labor pain.
- Conditions
- Pain
- Being tested
- combined spinal epidural
- Keywords
- Combined spinal epidural duration, labor pain
- Medical subject headings
- Pain, Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined spinal epiduralDrug
Combined Spinal Epidural
| Study group | Role | What they receive |
|---|---|---|
| Room temperature | Experimental | room temperature combined spinal epidural dose (60-75 degrees F) Receives: Drug: combined spinal epidural |
| refrigerated temperature | Active comparator | refrigerated temperature combined spinal epidural dose (~<43 degrees F) Receives: Drug: combined spinal epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time
length of time in minutes the combined spinal epidural dose duration is calculated from the time of administration until the request is made for additional analgesia (~1.5-3 hours) post dose. The subjects epidural is then dosed as per standard of care.
Measured: up to 3 hours
Secondary outcomes (4)
Analgesia Onset-5 Minutes Post Injection
Measured: from time of CSE administration
Analgesia Onset-10 Minutes Post Injection
Measured: up to 3 hours
Analgesia Onset-15 Minutes Post Injection
Measured: up to 3 hours
Pruritus
patients reporting pruritis at 30 minutes after CSE injection, self reported and measured on a scale of 0 (no itching at all) up to 10 (itching as bad as can be imagined)
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study start29 Aug 2013
- Primary completion4 May 2014
- Study completion4 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vernon Ross, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020304
- Sponsor's protocol ID
- IRB 23933
- Status last verified
- Sep 2018
- First submitted
- 21 Nov 2013
- Last updated
- 10 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Temperature of Combined Spinal Epidural Dosing on Duration
- ClinicalTrials.gov ID
- NCT02020304
- Acronym / sponsor ID
- IRB 23933
- Conditions
- Pain
- Keywords
- Combined spinal epidural duration, labor pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 29 Aug 2013 (actual)
- Primary completion
- 4 May 2014 (actual)
- Study completion
- 4 May 2014 (actual)
- First posted
- 24 Dec 2013 (estimated)
- Results
- Posted 24 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis is that a combined spinal-epidural drug at refrigerated temperature will have a shorter period of pain relief than that maintained at room temperature. The temperature of the dose of medication will be measure with an infrared thermometer immediately prior (within 5 minutes) to administration.
Detailed description
Subjects will receive a combined spinal epidural medication as per standard of care to treat their labor pain; however, they will be randomized to receive either a dose maintained at room temperature (60-75 degrees F) or one maintained in a refrigerator (~<43 degrees F). Duration of action will be done by assessments of pain, vital signs, nausea, itching, bromage and fetal heart rate every 15 minutes until the subject requests additional pain medication to treat their labor pain.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Room temperature | Experimental | Drug: combined spinal epiduralroom temperature combined spinal epidural dose (60-75 degrees F) |
| refrigerated temperature | Active comparator | Drug: combined spinal epiduralrefrigerated temperature combined spinal epidural dose (~<43 degrees F) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- >/= 18 years of age not allergic to medications used to treat labor pain </= 6cm cervical dilation visual pain score >/=3
Key exclusion criteria (1 listed)
- <18 years of age > 6 cm cervical dilation non-English speaking subjects
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 |
|---|---|---|
| combined spinal epiduralCombined Spinal Epidural | Drug | Room temperature, refrigerated temperature |
Primary outcome
Time
Time frame: up to 3 hours
length of time in minutes the combined spinal epidural dose duration is calculated from the time of administration until the request is made for additional analgesia (~1.5-3 hours) post dose. The subjects epidural is then dosed as per standard of care.
4 secondary outcomes
Analgesia Onset-5 Minutes Post Injection
Time frame: from time of CSE administration
Analgesia Onset-10 Minutes Post Injection
Time frame: up to 3 hours
Analgesia Onset-15 Minutes Post Injection
Time frame: up to 3 hours
Pruritus
Time frame: 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Vernon Ross, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing combined spinal epidural in people with Pain, run by Wake Forest University Health Sciences 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 1 inclusion and 1 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 10 Sep 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: up to 3 hours). 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 10 Sep 2018.