Labor PainPhase 1NCT00779467
Epidural Neostigmine for Labor Pain
A Phase 1 study testing Neostigmine, Bupivacaine and fentanyl in people with Labor Pain, run by Wake Forest University at 1 site in United States.
Trial summary
The purpose of this study is to see which dose of epidural neostigmine is the best additive to use with the numbing medication used in an epidural during labor. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Neostigmine, Bupivacaine and fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Nov 2013
- Phase
- Phase 1
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy pregnancy
- Term pregnancy ( > 37 weeks)
- Primiparous or multiparous
- Induction or spontaneous labor greater or = 18 years of age
- Cervical exam on entry </=5 cm
Who cannot join
- Weight > 115 kg
- Non-English speaking
- IV analgesics within 60 minutes prior to epidural being administered
- Allergy to local anesthetics or neostigmine
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: Epidural Neostigmine Dose Response for the Treatment of Labor Pain
The purpose of this study is to see which dose of epidural neostigmine is the best additive to use with the numbing medication used in an epidural during labor.
Read the detailed description
This study is examining the use of the non-narcotic medication, neostigmine, in combination with the local anesthetic bupivacaine when compared with the commonly used narcotic fentanyl in providing pain relief with the fewest side effects in labor analgesia.
- Conditions
- Labor Pain
- Being tested
- Neostigmine, Bupivacaine, fentanyl
- Keywords
- non narcotic, epidural, labor pain, Non narcotic treatment of labor pain
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeostigmineDrug
utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
BupivacaineDrug
fentanylDrug
fentanyl 2 mcg/ml
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine with Neostimgine 8 mcg/ml | Experimental | STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML Receives: Drug: Neostigmine; Drug: Bupivacaine |
| Bupivacaine and Neostigmine 4 mcg/ml | Experimental | STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML Receives: Drug: Neostigmine; Drug: Bupivacaine |
| Bupivacaine with Neostigmine 2 mcg/ml | Experimental | STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML Receives: Drug: Neostigmine; Drug: Bupivacaine |
| BUPIVACAINE WITH FENTANYL 2 MCG/ML | Active comparator | Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION Receives: Drug: Bupivacaine; Drug: fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Drug Consumed Per Hour in Each Group(Arm)
Median hourly total bupivacaine consumption. Drug amount consumed per hour of each group (arm)
Measured: until delivery
Secondary outcomes (7)
Nausea
average maximum nausea score in each group--maternal nausea scored on a 0-no nausea at all up to maximum of 10-worst nausea imaginable
Measured: until delivery
Sedation
average maternal sedation score measured on a 0-not sleepy at all up to a maximum of 10-extremely sleepy
Measured: until delivery
Shivering
maternal occurrence of shivering--Shivering scored on a 0-no shivering at all up to maximum of 10-shivering uncontrollably
Measured: until delivery
Pruritus
the occurrence of pruritis (itching) throughout the labor analgesia infusion--the presence of itching rated on a scale of 0-no itching at all up to a maximum of 10- severe itching.
Measured: until delivery
Bromage Score
the incidence of decreased motor block (Bromage score) documented until delivery. Bromage is defined as 0-freely able to move extremities (no motor block) up to 3-unable to move legs or feet (complete motor block)
Measured: until delivery
Patient Satisfaction Scores
maternal reported satisfaction scores of labor analgesia on a scale of 1-5, with 1-not satisfied at all up to 5 -completely satisfied with labor analgesia
Measured: within 24 hours post delivery
Cesarean Delivery
percentage of subjects in each group requiring a ceserean delivery
Measured: occurence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionNov 2013
- Study completionNov 2013
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 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, Wake Forest University Health Sciences OB Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779467
- Sponsor's protocol ID
- IRB00005917
- Status last verified
- Aug 2018
- First submitted
- 22 Oct 2008
- Last updated
- 11 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 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Neostigmine Dose Response for the Treatment of Labor Pain
- ClinicalTrials.gov ID
- NCT00779467
- Acronym / sponsor ID
- IRB00005917
- Conditions
- Labor Pain
- Keywords
- non narcotic, epidural, labor pain, Non narcotic treatment of labor pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 24 Oct 2008 (estimated)
- Results
- Posted 10 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see which dose of epidural neostigmine is the best additive to use with the numbing medication used in an epidural during labor.
Detailed description
This study is examining the use of the non-narcotic medication, neostigmine, in combination with the local anesthetic bupivacaine when compared with the commonly used narcotic fentanyl in providing pain relief with the fewest side effects in labor analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine with Neostimgine 8 mcg/ml | Experimental | Drug: Neostigmine, Drug: BupivacaineSTUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML |
| Bupivacaine and Neostigmine 4 mcg/ml | Experimental | Drug: Neostigmine, Drug: BupivacaineSTUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML |
| Bupivacaine with Neostigmine 2 mcg/ml | Experimental | Drug: Neostigmine, Drug: BupivacaineSTUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML |
| BUPIVACAINE WITH FENTANYL 2 MCG/ML | Active comparator | Drug: Bupivacaine, Drug: fentanylBupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy pregnancy
- Term pregnancy ( > 37 weeks)
- Primiparous or multiparous
- Induction or spontaneous labor greater or = 18 years of age
- Cervical exam on entry </=5 cm
Key exclusion criteria (4 listed)
- Weight > 115 kg
- Non-English speaking
- IV analgesics within 60 minutes prior to epidural being administered
- Allergy to local anesthetics or neostigmine
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 |
|---|---|---|
| Neostigmineutilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. | Drug | Bupivacaine and Neostigmine 4 mcg/ml, Bupivacaine with Neostigmine 2 mcg/ml, Bupivacaine with Neostimgine 8 mcg/ml |
| Bupivacaine | Drug | BUPIVACAINE WITH FENTANYL 2 MCG/ML, Bupivacaine and Neostigmine 4 mcg/ml, Bupivacaine with Neostigmine 2 mcg/ml, Bupivacaine with Neostimgine 8 mcg/ml |
| fentanylfentanyl 2 mcg/ml | Drug | BUPIVACAINE WITH FENTANYL 2 MCG/ML |
Primary outcome
Amount of Drug Consumed Per Hour in Each Group(Arm)
Time frame: until delivery
Median hourly total bupivacaine consumption. Drug amount consumed per hour of each group (arm)
7 secondary outcomes
Nausea
Time frame: until delivery
Sedation
Time frame: until delivery
Shivering
Time frame: until delivery
Pruritus
Time frame: until delivery
Bromage Score
Time frame: until delivery
Patient Satisfaction Scores
Time frame: within 24 hours post delivery
Cesarean Delivery
Time frame: occurence
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 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.
Peter H Pan, MD principal investigator
Wake Forest University Health Sciences OB Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neostigmine, Bupivacaine and fentanyl 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 5 inclusion and 4 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 11 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 10 Apr 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?
Amount of Drug Consumed Per Hour in Each Group(Arm) (time frame: until delivery). 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 11 Sep 2018.