Labor PainPhase 2NCT01062893
Combined Spinal/Epidural (CSE) Saline Duration/Spread
A Phase 2 study testing Sterile normal saline 0 mls and 15 mls sterile normal saline in people with Labor Pain, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
An attempt is being made to see if by injecting a set volume of sterile saline into the epidural space during the treatment of labor pain with a combined spinal/epidural (CSE) increases the amount of pain relief obtained and makes the labor analgesia lasts longer. 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?
- Sterile normal saline 0 mls and 15 mls sterile normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Sep 2012
- 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 12 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age greater than 12 years of age
- ASA status 1 or 2
- cervical dilation < 6cm
Who cannot join
- ASA assigned 3 or 4
- advanced labor (> 6cm cervical dilated)
- distorted epidural anatomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Forsyth Medical Center-Sara Lee Center for Women's Health
Winston-Salem, North Carolina, 27103
About this study
Official title: Effect of Epidural Saline on Duration and Spread of Subsequent Spinal Analgesia/Anesthesia Using a CSE Technique
An attempt is being made to see if by injecting a set volume of sterile saline into the epidural space during the treatment of labor pain with a combined spinal/epidural (CSE) increases the amount of pain relief obtained and makes the labor analgesia lasts longer. Subjects are in the study from the time their CSE is placed until they request additional pain medication from the spinal dose of numbing medicine wearing off.
- Conditions
- Labor Pain
- Being tested
- Sterile normal saline 0 mls, 15 mls sterile normal saline
- Keywords
- labor pain treatment, duration analgesia, Analgesic duration with normal saline injection., Analgesic duration without normal saline injection
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterile normal saline 0 mlsOther
at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor.
15 mls sterile normal salineOther
After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications.
| Study group | Role | What they receive |
|---|---|---|
| 0 mls saline injected | Placebo comparator | NO SALINE INJECTED Receives: Other: Sterile normal saline 0 mls |
| 15 mls saline | Active comparator | 15ML SALINE ADMINISTERED EPIDURALLY Receives: Other: 15 mls sterile normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Highest Sensory Blockade Level to Pinprick and to Cold
Onset of analgesia to recession of analgesia. Highest spread of analgesia (highest sensory level) to cold temp and pinprick, with level defined from T1 to L5, where T1 is highest =level 17 and L5 is lowest =Level 1)
Measured: up to 20 minutes
Secondary outcomes (10)
Duration of Analgesia (Time to Request Additional Analgesia)
time of CSE to time request of additional supplement analgesia in minutes
Measured: up 120 minutes
Onset of Analgesia
time to VAS</=3 on a 0-10 scale with 0=no pain up to 10= worst pain imaginable
Measured: up to 20 minutes
Time to Highest Sensory Block
Measured: up to 20 minutes
Number of Participants Who Had Occurrence of Fetal Bradycardia
occurrence of common side effects of spinal/epidural administration
Measured: length of labor, up to 24 hours
Number of Participants Who Had Occurrence of Maternal Hypotension
Measured: length of labor, up to 24 hours
Occurrence of Use of Vasopressors
Measured: length of labor, up to 24 hours
Number of Participants Who Had Occurrence of Itching
Measured: length of labor, up to 24 hours
Number of Participants Who Had Occurrence of Post Dural Puncture Headache
Measured: length of labor, up to 24 hours
Time for 2 Dermatome Level Regression of Sensory Block
Measured: up to 20 minutes
Time for Regression of Motor Blockade
Measured: up to 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startAug 2009
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: lack of subjects and manpower issues
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter H Pan, MD, MSEE, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062893
- Sponsor's protocol ID
- IRB00009631
- Status last verified
- Oct 2018
- First submitted
- 1 Feb 2010
- Last updated
- 16 Oct 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 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Epidural Saline on Duration and Spread of Subsequent Spinal Analgesia/Anesthesia Using a CSE Technique
- ClinicalTrials.gov ID
- NCT01062893
- Acronym / sponsor ID
- IRB00009631
- Conditions
- Labor Pain
- Keywords
- labor pain treatment, duration analgesia, Analgesic duration with normal saline injection., Analgesic duration without normal saline injection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of subjects and manpower issues
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 4 Feb 2010 (estimated)
- Results
- Posted 16 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An attempt is being made to see if by injecting a set volume of sterile saline into the epidural space during the treatment of labor pain with a combined spinal/epidural (CSE) increases the amount of pain relief obtained and makes the labor analgesia lasts longer. Subjects are in the study from the time their CSE is placed until they request additional pain medication from the spinal dose of numbing medicine wearing off.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0 mls saline injected | Placebo comparator | Other: Sterile normal saline 0 mlsNO SALINE INJECTED |
| 15 mls saline | Active comparator | Other: 15 mls sterile normal saline15ML SALINE ADMINISTERED EPIDURALLY |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- age greater than 12 years of age
- ASA status 1 or 2
- cervical dilation < 6cm
Key exclusion criteria (3 listed)
- ASA assigned 3 or 4
- advanced labor (> 6cm cervical dilated)
- distorted epidural anatomy
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 |
|---|---|---|
| Sterile normal saline 0 mlsat time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor. | Other | 0 mls saline injected |
| 15 mls sterile normal salineAfter the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications. | Other | 15 mls saline |
Primary outcome
Highest Sensory Blockade Level to Pinprick and to Cold
Time frame: up to 20 minutes
Onset of analgesia to recession of analgesia. Highest spread of analgesia (highest sensory level) to cold temp and pinprick, with level defined from T1 to L5, where T1 is highest =level 17 and L5 is lowest =Level 1)
10 secondary outcomes
Duration of Analgesia (Time to Request Additional Analgesia)
Time frame: up 120 minutes
Onset of Analgesia
Time frame: up to 20 minutes
Time to Highest Sensory Block
Time frame: up to 20 minutes
Number of Participants Who Had Occurrence of Fetal Bradycardia
Time frame: length of labor, up to 24 hours
Number of Participants Who Had Occurrence of Maternal Hypotension
Time frame: length of labor, up to 24 hours
Occurrence of Use of Vasopressors
Time frame: length of labor, up to 24 hours
Number of Participants Who Had Occurrence of Itching
Time frame: length of labor, up to 24 hours
Number of Participants Who Had Occurrence of Post Dural Puncture Headache
Time frame: length of labor, up to 24 hours
Time for 2 Dermatome Level Regression of Sensory Block
Time frame: up to 20 minutes
Time for Regression of Motor Blockade
Time frame: up to 20 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 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, MSEE 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 Sterile normal saline 0 mls and 15 mls sterile normal saline in people with Labor 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 3 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: stopped early, as of the sponsor's last update on 16 Oct 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. 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 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 16 Oct 2018). 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?
Highest Sensory Blockade Level to Pinprick and to Cold (time frame: up to 20 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 16 Oct 2018.