Labor PainPhase 4NCT01005459
Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE
A Phase 4 study testing Tetracaine and Bupivacaine in people with Labor Pain, run by Wake Forest University at 1 site in United States.
Trial summary
The investigators hypothesis is that spinal tetracaine with fentanyl and epinephrine used for CSE labor analgesia volume will last a significantly longer period of time that that of spinal bupivacaine with fentanyl. Read more about this study
- Who is it for?
- Ages 12 years and older, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Tetracaine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to 12 Dec 2011
- Phase
- Phase 4
- 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 12 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- early labor (>=2cm but =<6cm cervical dilation)
- at least 12 years of age
- have an assigned ASA physical status 1 or 2
- singleton pregnancy
Who cannot join
- contraindications to neuraxial anesthesia
- with allergies to drugs used in the study
- have an assigned ASA status 3 or 4
- advanced labor (> 6cm cervical dilation)
- less than 12 years of age
- Patients with the potential for distorted epidural anatomy, such as Harrington rods or prior back surgery, will also be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Forsyth Medical Center- OB Anesthesia dept
Winston-Salem, North Carolina, 27103
About this study
Official title: Comparison of Spinal Tetracaine With Fentanyl and Epinephrine Versus Bupivacaine With Fentanyl and Epinephrine for Combined Spinal Epidural Labor Analgesia
The investigators hypothesis is that spinal tetracaine with fentanyl and epinephrine used for CSE labor analgesia volume will last a significantly longer period of time that that of spinal bupivacaine with fentanyl. After informed consent is obtained for the study, subjects meeting criteria when analgesia is requested will be randomized to receive a combined spinal-epidural containing either tetracaine 2 mg with fentanyl and epinephrine or bupivacaine 2 mg with fentanyl and epinephrine.
- Conditions
- Labor Pain
- Being tested
- Tetracaine, Bupivacaine
- Keywords
- labor pain, combined spinal epidural labor analgesia, CSE analgesia, labor analgesia
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetracaineDrug
Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.
BupivacaineDrug
Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.
| Study group | Role | What they receive |
|---|---|---|
| tetracaine 2mg | Active comparator | Not described Receives: Drug: Tetracaine |
| Bupivacaine 2 mg | Active comparator | Not described Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal Analgesic Duration
duration of time in minutes from the time the combined spinal epidural is placed until the participant requests additional analgesia; at that time the epidural was dosed and study participation was complete
Measured: 1-2 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startAug 2009
- Primary completion12 Dec 2011
- Study completion12 Dec 2011
Why it stopped: feasibility /drug availability issues - No study drug sources available
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 Labor PainStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter H. Pan, MD, Principal investigator, WFUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005459
- Sponsor's protocol ID
- IRB 9824
- Status last verified
- Jun 2017
- First submitted
- 30 Oct 2009
- Last updated
- 8 Nov 2017
- 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 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Spinal Tetracaine With Fentanyl and Epinephrine Versus Bupivacaine With Fentanyl and Epinephrine for Combined Spinal Epidural Labor Analgesia
- ClinicalTrials.gov ID
- NCT01005459
- Acronym / sponsor ID
- IRB 9824
- Conditions
- Labor Pain
- Keywords
- labor pain, combined spinal epidural labor analgesia, CSE analgesia, labor analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: feasibility /drug availability issues - No study drug sources available
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- 12 Dec 2011 (actual)
- Study completion
- 12 Dec 2011 (actual)
- First posted
- 2 Nov 2009 (estimated)
- Results
- Posted 13 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesis is that spinal tetracaine with fentanyl and epinephrine used for CSE labor analgesia volume will last a significantly longer period of time that that of spinal bupivacaine with fentanyl. After informed consent is obtained for the study, subjects meeting criteria when analgesia is requested will be randomized to receive a combined spinal-epidural containing either tetracaine 2 mg with fentanyl and epinephrine or bupivacaine 2 mg with fentanyl and epinephrine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tetracaine 2mg | Active comparator | Drug: Tetracaine |
| Bupivacaine 2 mg | Active comparator | Drug: Bupivacaine |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- early labor (>=2cm but =<6cm cervical dilation)
- at least 12 years of age
- have an assigned ASA physical status 1 or 2
- singleton pregnancy
Key exclusion criteria (6 listed)
- contraindications to neuraxial anesthesia
- with allergies to drugs used in the study
- have an assigned ASA status 3 or 4
- advanced labor (> 6cm cervical dilation)
- less than 12 years of age
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 |
|---|---|---|
| TetracaineTetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain. | Drug | tetracaine 2mg |
| BupivacaineBupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain. | Drug | Bupivacaine 2 mg |
Primary outcome
Spinal Analgesic Duration
Time frame: 1-2 hrs
duration of time in minutes from the time the combined spinal epidural is placed until the participant requests additional analgesia; at that time the epidural was dosed and study participation was complete
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
- 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.
Peter H. Pan, MD principal investigator
WFUHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tetracaine and Bupivacaine in people with Labor Pain, run by Wake Forest 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 6 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: stopped early, as of the sponsor's last update on 8 Nov 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 13 Jul 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?
Spinal Analgesic Duration (time frame: 1-2 hrs). 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 8 Nov 2017.