Labor PainPhase 4NCT01651962
Intravenous Terbutaline to Facilitate Labor Epidural Catheter Placement
A Phase 4 study testing Terbutaline, Fentanyl and 0.9% NaCl in people with Labor Pain, run by Kai Schoenhage at 2 sites in United States.
Trial summary
Labor pain is a major factor in making the placement of an epidural catheter difficult. The epidural, once in place and dosed, eventually decreases the parturient's pain. To achieve this goal as fast and safely as possible it would be helpful to have a parturient who can tolerate and co-operate with the placement of… Read more about this study
- Who is it for?
- Ages 18 to 53 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Terbutaline, Fentanyl and 0.9% NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2012to Dec 2015
- Phase
- Phase 4
- 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 53 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- in labor
- labor pain >3 on visual analog scale (VAS)
Who cannot join
- cardiovascular disease
- preeclampsia
- diabetes mel-litus
- thyroid disease
- current (outpatient) opioid medication
- recent and / or current use of cocaine
Show all 11Show fewer
- seizure disorder
- psychiatric disease
- body mass index >35
- preterm labor (<37 weeks pregnant)
- known allergies to any of the three study substances
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Tucson Medical Center
Tucson, Arizona, 85712
Schoenhage Monique, M.D.
- Recruiting
University of Arizona Medical Center
Tucson, Arizona, 85724
Kai Schoenhage, M.D.
About this study
Official title: Intravenous Terbutaline to Facilitate Epidural Catheter Placement for Parturients With Labor Pain
Labor pain is a major factor in making the placement of an epidural catheter difficult. The epidural, once in place and dosed, eventually decreases the parturient's pain. To achieve this goal as fast and safely as possible it would be helpful to have a parturient who can tolerate and co-operate with the placement of the epidural catheter.
Briefly stopping contractions, the cause of labor pain, could be the key to achieve this goal.
This study will evaluate the safety, efficacy and duration of the drug terbutaline for this purpose.
- Conditions
- Labor Pain
- Being tested
- Terbutaline, Fentanyl, 0.9% NaCl
- Keywords
- Labor Pain, Analgesia, Epidural
- Medical subject headings
- Labor Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerbutalineDrug
FentanylDrug
0.9% NaClDrug
Also called normal saline
| Study group | Role | What they receive |
|---|---|---|
| Terbutaline | Experimental | Terbutaline 0.125mg i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN Receives: Drug: Terbutaline |
| Fentanyl | Active comparator | Fentanyl 100mcg i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN Receives: Drug: Fentanyl |
| Placebo | Placebo comparator | 0.9% NaCl i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN Receives: Drug: 0.9% NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of pain score on a visual analog scale (VAS) of 1-10
semi-quantitative assessment of decrease in the subject's pain score after administration of the study drug for the placement of an epidural catheter
Measured: 0-30 minutes
Secondary outcomes (2)
movement during epidural placement
semi-quantitative assessment of the subject's movement during placement of the epidural catheter: 0-1-2-3: none - extremities - trunk a bit - trunk a lot
Measured: 0-30 minutes
position during epidural placement
semi-quantitative assessment of the subject's position during the epidural catheter placement: 0-1-2: excellent - moderate - poor
Measured: 0-30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kai Schoenhage
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kai Schoenhage, University of Arizona
- Investigators
- Kai Schoenhage, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651962
- Sponsor's protocol ID
- 12-0412
- Status last verified
- Jan 2015
- First submitted
- 20 Jul 2012
- Last updated
- 19 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Terbutaline to Facilitate Epidural Catheter Placement for Parturients With Labor Pain
- ClinicalTrials.gov ID
- NCT01651962
- Acronym / sponsor ID
- 12-0412
- Conditions
- Labor Pain
- Keywords
- Labor Pain, Analgesia, Epidural
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Kai SchoenhageUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 27 Jul 2012 (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.
Labor pain is a major factor in making the placement of an epidural catheter difficult. The epidural, once in place and dosed, eventually decreases the parturient's pain. To achieve this goal as fast and safely as possible it would be helpful to have a parturient who can tolerate and co-operate with the placement of the epidural catheter.
Briefly stopping contractions, the cause of labor pain, could be the key to achieve this goal.
This study will evaluate the safety, efficacy and duration of the drug terbutaline for this purpose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Terbutaline | Experimental | Drug: TerbutalineTerbutaline 0.125mg i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN |
| Fentanyl | Active comparator | Drug: FentanylFentanyl 100mcg i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN |
| Placebo | Placebo comparator | Drug: 0.9% NaCl0.9% NaCl i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN |
Who may qualify
- Ages
- 18 to 53 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- in labor
- labor pain >3 on visual analog scale (VAS)
Key exclusion criteria (11 listed)
- cardiovascular disease
- preeclampsia
- diabetes mel-litus
- thyroid disease
- current (outpatient) opioid medication
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 |
|---|---|---|
| Terbutaline | Drug | Terbutaline |
| Fentanyl | Drug | Fentanyl |
| 0.9% NaClAlso: normal saline | Drug | Placebo |
Primary outcome
reduction of pain score on a visual analog scale (VAS) of 1-10
Time frame: 0-30 minutes
semi-quantitative assessment of decrease in the subject's pain score after administration of the study drug for the placement of an epidural catheter
2 secondary outcomes
movement during epidural placement
Time frame: 0-30 minutes
position during epidural placement
Time frame: 0-30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2015.
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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.
Kai Schoenhage, MD principal investigator
University of Arizona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Terbutaline, Fentanyl and 0.9% NaCl in people with Labor Pain, run by Kai Schoenhage at 2 sites 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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 19 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai Schoenhage, MD ((520) 626-7221, kschoenhage@anesth.arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of pain score on a visual analog scale (VAS) of 1-10 (time frame: 0-30 minutes). 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 19 Jan 2015.