PainEpiduralNCT00810914
Patient Controlled Epidural Analgesia Versus Continuous Epidural Infusion: Obstetrical and Neonatal Outcomes
A study testing bupivicaine epidural, bupivicaine epidural infusion patient epidural and bupivicaine in people with Pain, run by MemorialCare at 1 site in United States.
Trial summary
The investigators intend to perform a large randomized trial using standardized obstetrical and anesthetic practice at a single institution to determine the effects of patient controlled epidural analgesia on obstetrical and neonatal outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- bupivicaine epidural, bupivicaine epidural infusion patient epidural and bupivicaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Dec 2010
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Early labor
- Nulliparous
Who cannot join
- Inductions
- Breech
- Contraindications to regional anesthesia
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Long Beach Memorial Medical Center
Long Beach, California, 90806
Christine Preslicka, RN, 562-933-2750, cpreslicka@memorialcare.org
Michael Haydon, MD
About this study
Official title: Patient Controlled Epidural Infusion Vs. Continuous Epidural Infusion: Obstetrical and Neonatal Outcomes
The investigators intend to perform a large randomized trial using standardized obstetrical and anesthetic practice at a single institution to determine the effects of patient controlled epidural analgesia on obstetrical and neonatal outcomes.
Read the detailed description
Women in their first pregnancy in spontaneous labor desiring epidural anesthesia will be randomized to one of three groups. Each group will initially be given intrathecal bolus. Before and 30 minutes after the initial bolus, the patient's verbal pain score will be recorded. The continuous epidural infusion group (Group I) will be started immediately on a continuous pump infusion.They will also have the opportunity to give a PCA bolus Finally, the patient controlled epidural group (Group III) will be able to give a bolus every 20 minutes with no continuous infusion. Each group will also be allowed 2 boluses,by the anesthesia staff in the event that their pain is not controlled by the indicated study medication. An hourly evaluation of verbal pain score and maternal mobility will be recorded. After delivery, obstetrical outcomes, neonatal outcomes, anesthesia interventions, and patient satisfaction questionnaires will then be collected.
- Conditions
- Pain
- Being tested
- bupivicaine epidural, bupivicaine epidural infusion patient epidural, bupivicaine
- Keywords
- Patient controlled epidural anesthesia, Pain control in labor
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivicaine epiduralDrug
Also called Marcaine
bupivicaine continuous epidural infusion
bupivicaine epidural infusion patient epiduralDrug
Also called marcaine
bupivicaine
bupivicaineDrug
Also called marcaine
patient controlled anesthesia only
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Continuous epidural infusion of medication for method of pain relief Receives: Drug: bupivicaine epidural |
| 2 | Experimental | continuous epidural infusion in conjuction with patient controlled anesthesia (PCA) Receives: Drug: bupivicaine epidural infusion patient epidural |
| 3 | Experimental | patient controlled anesthesia only this arm has pt controlled medication delivery. (PCA) Receives: Drug: bupivicaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total bupivicaine used
Measured: End of labor
Secondary outcomes (1)
maternal satisfaction
Measured: End of labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startMar 2006
- Primary completionJun 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MemorialCare
- Sponsor type
- University, hospital or other
- Investigators
- Michael Haydon, MD, Principal investigator, Memorial care Health Sytem Physcian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810914
- Sponsor's protocol ID
- 333-06
- Other IDs
- MHS 801001-R433306
- Acronym
- Epidural
- Status last verified
- Sep 2009
- First submitted
- 19 Feb 2008
- Last updated
- 18 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Controlled Epidural Infusion Vs. Continuous Epidural Infusion: Obstetrical and Neonatal Outcomes
- ClinicalTrials.gov ID
- NCT00810914
- Acronym / sponsor ID
- Epidural / 333-06
- Conditions
- Pain
- Keywords
- Patient controlled epidural anesthesia, Pain control in labor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- MemorialCareUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 18 Dec 2008 (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.
The investigators intend to perform a large randomized trial using standardized obstetrical and anesthetic practice at a single institution to determine the effects of patient controlled epidural analgesia on obstetrical and neonatal outcomes.
Detailed description
Women in their first pregnancy in spontaneous labor desiring epidural anesthesia will be randomized to one of three groups. Each group will initially be given intrathecal bolus. Before and 30 minutes after the initial bolus, the patient's verbal pain score will be recorded. The continuous epidural infusion group (Group I) will be started immediately on a continuous pump infusion.They will also have the opportunity to give a PCA bolus Finally, the patient controlled epidural group (Group III) will be able to give a bolus every 20 minutes with no continuous infusion. Each group will also be allowed 2 boluses,by the anesthesia staff in the event that their pain is not controlled by the indicated study medication. An hourly evaluation of verbal pain score and maternal mobility will be recorded. After delivery, obstetrical outcomes, neonatal outcomes, anesthesia interventions, and patient satisfaction questionnaires will then be collected.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: bupivicaine epiduralContinuous epidural infusion of medication for method of pain relief |
| 2 | Experimental | Drug: bupivicaine epidural infusion patient epiduralcontinuous epidural infusion in conjuction with patient controlled anesthesia (PCA) |
| 3 | Experimental | Drug: bupivicainepatient controlled anesthesia only this arm has pt controlled medication delivery. (PCA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Early labor
- Nulliparous
Key exclusion criteria (3 listed)
- Inductions
- Breech
- Contraindications to regional anesthesia
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 |
|---|---|---|
| bupivicaine epiduralAlso: Marcainebupivicaine continuous epidural infusion | Drug | 1 |
| bupivicaine epidural infusion patient epiduralAlso: marcainebupivicaine | Drug | 2 |
| bupivicaineAlso: marcainepatient controlled anesthesia only | Drug | 3 |
Primary outcome
Total bupivicaine used
Time frame: End of labor
1 secondary outcome
maternal satisfaction
Time frame: End of labor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2009.
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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.
Michael Haydon, MD principal investigator
Memorial care Health Sytem Physcian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bupivicaine epidural, bupivicaine epidural infusion patient epidural and bupivicaine in people with Pain, run by MemorialCare 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 2 inclusion and 3 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 18 Sep 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine Preslicka, RN (562-933-2755, cpreslicka@memorialcare.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total bupivicaine used (time frame: End of labor). 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 18 Sep 2009.