ParturientsPhase 3NCT01119079
Study to Determine Whether the Instillation of 10ml Normal Saline Improves Epidural Analgesia During Labor
A Phase 3 study testing Normal Saline and Administration of epidural anesthesia for labor in people with Parturients, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial summary
In current obstetric anesthesia practice, epidural analgesia is the most effective technique to control labor pain for those women who request pain-free delivery. Epidural analgesia not only allows us to obtain greater pain relief and increased satisfaction of mothers, but also permits us to convert it to regional… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Parturients
- What is being tested?
- Normal Saline and Administration of epidural anesthesia for labor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Sep 2012
- Phase
- Phase 3
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists class I-II term parturients with singleton vertex presentation in active labor
- Patients who have cervical dilatation between 3 and 7 centimeters
Who cannot join
- • Patients with contraindications to epidural analgesia,
- severe medical or obstetric complications,
- morbid obesity (body mass index >40 kg/m2),
- history of drug or alcohol abuse,
- abnormal hepatic (AST/ALT), renal (creatinine levels), or hematological (PTT levels) test results.
- presence of blood on the second insertion into the intervertebral space
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- presence of cerebral spinal fluid upon insertion into the intervertebral space
- subjects who deliver (either vaginally or via cesarean section) within 2 hours of the epidural insertion
- subjects less than 36 weeks gestation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Prospective Study to Establish Whether the Instillation of 10ml of Epidural Normal Saline Improves the Quality Of Epidural Analgesia During Labor
In current obstetric anesthesia practice, epidural analgesia is the most effective technique to control labor pain for those women who request pain-free delivery. Epidural analgesia not only allows us to obtain greater pain relief and increased satisfaction of mothers, but also permits us to convert it to regional anesthesia in case of operative delivery, avoiding general anesthesia.
One of the major concerns with epidural anesthesia in labor setting is the inability to produce an intensive analgesia or adequate level to proceed with cesarean section. This study is designed to examine the hypothesis that 10ml epidural normal saline to reduce rate of one-side block, low segmental block, and patch block, and improve quality of labor epidural analgesia/ anesthesia in obstetric population.
Read the detailed description
One of the major concerns with epidural anesthesia in labor setting is the inability to produce an intensive analgesia or adequate level to proceed with cesarean section. The incidence of this event is rather various among reports, reflecting variability in definitions, authors' clinical judgment and perception, practice parameters, hospital settings. In most of related studies, the term of incomplete block was used and defined as (1) unilateral block; (2) unblocked sacral segments; (3) low level; (4) unblocked segments or a patchy block. 1Reported incidence of inadequate analgesia/anesthesia was 18% to 31.8%. In addition, the reported incidence of intraoperative discomfort/visceral pain was from 10% to 56%.1
If the anesthesia/analgesia is not adequate, other treatment modalities have to be provided to improve pain relief, these include intravenous narcotics or ketamine, replacements of epidural catheter, or general anesthesia, the risks of complications may be increased by those managements.
The etiology and mechanisms of failed or dysfunctional epidural analgesia or anesthesia in obstetrics are complex, multifactorial, and not entirely understood. Depending on the situation, the causes might be evident or puzzling and difficult to explain.
Injection of fluid is frequently used for identification of the epidural space by the loss-of-resistance (LOR) technique. It has been shown that different volumes of saline may affect the subsequent epidural analgesia. Iwama showed that using 10 mL of saline as compared to two mL in patients undergoing elective surgery during lumbar epidural anesthesia with 2% mepivacaine resulted in a greater extent of anesthesia.2 Also, Okutomi et al examined the effect of saline volume on anesthetic levels and quality of thoracic epidural block in patients undergoing upper abdominal surgery. They demonstrated that the block level for cold after mepivacaine 1.5% was proportional to the saline volume injected, whereas the block level for pain was independent of the saline solution.3 Identifying the epidural space by a lost of resistance to air method is thought to increase the incidence of inadequate anesthesia. A randomized study, comparing air versus saline to identify the epidural space in parturients, found a higher incidence of inadequate analgesia in the air group (36% versus 19%).4
In parturients requesting epidural analgesia, a few studies showed that 2- 10ml normal saline giving to epidural space after LOR was obtained reduced the rate of venous puncture and unblock segments to cold and pin prick, but did not improve the visual analog pain scale or reduced the need for supplemental.3,5,6 No study on improvement of unilateral block, patch block and patients' satisfaction in obstetric setting has been found.
We design this study to examine the hypothesis that 10ml epidural normal saline to reduce rate of one-side block, low segmental block, and patch block, and improve quality of labor epidural analgesia/ anesthesia in obstetric population.
- Conditions
- Parturients
- Being tested
- Normal Saline, Administration of epidural anesthesia for labor
- Keywords
- labor pain, epidural
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal SalineOther
10ml Normal Saline instilled in the epidural space
Administration of epidural anesthesia for laborProcedure or surgery
Standard procedure
| Study group | Role | What they receive |
|---|---|---|
| Standard labor epidural protocol | Placebo comparator | Standard labor epidural protocol Receives: Procedure: Administration of epidural anesthesia for labor |
| 10ml Normal Saline prior to lidocaine | Experimental | Not described Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
improve quality of labor epidural analgesia/ anesthesia in obstetric population.
Measured: Administration of epidural anesthesia + 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2012 (estimated)
- Study completionSep 2012 (estimated)
Why it stopped: PI unable to recruit appropriate patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParturientsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dongchen Li, MD, PhD, Principal investigator, UMDNJ-NJMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119079
- Sponsor's protocol ID
- 0120090228
- Status last verified
- Apr 2015
- First submitted
- 6 May 2010
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective Study to Establish Whether the Instillation of 10ml of Epidural Normal Saline Improves the Quality Of Epidural Analgesia During Labor
- ClinicalTrials.gov ID
- NCT01119079
- Acronym / sponsor ID
- 0120090228
- Conditions
- Parturients
- Keywords
- labor pain, epidural
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI unable to recruit appropriate patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 7 May 2010 (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.
In current obstetric anesthesia practice, epidural analgesia is the most effective technique to control labor pain for those women who request pain-free delivery. Epidural analgesia not only allows us to obtain greater pain relief and increased satisfaction of mothers, but also permits us to convert it to regional anesthesia in case of operative delivery, avoiding general anesthesia.
One of the major concerns with epidural anesthesia in labor setting is the inability to produce an intensive analgesia or adequate level to proceed with cesarean section. This study is designed to examine the hypothesis that 10ml epidural normal saline to reduce rate of one-side block, low segmental block, and patch block, and improve quality of labor epidural analgesia/ anesthesia in obstetric population.
Detailed description
One of the major concerns with epidural anesthesia in labor setting is the inability to produce an intensive analgesia or adequate level to proceed with cesarean section. The incidence of this event is rather various among reports, reflecting variability in definitions, authors' clinical judgment and perception, practice parameters, hospital settings. In most of related studies, the term of incomplete block was used and defined as (1) unilateral block; (2) unblocked sacral segments; (3) low level; (4) unblocked segments or a patchy block. 1Reported incidence of inadequate analgesia/anesthesia was 18% to 31.8%. In addition, the reported incidence of intraoperative discomfort/visceral pain was from 10% to 56%.1
If the anesthesia/analgesia is not adequate, other treatment modalities have to be provided to improve pain relief, these include intravenous narcotics or ketamine, replacements of epidural catheter, or general anesthesia, the risks of complications may be increased by those managements.
The etiology and mechanisms of failed or dysfunctional epidural analgesia or anesthesia in obstetrics are complex, multifactorial, and not entirely understood. Depending on the situation, the causes might be evident or puzzling and difficult to explain.
Injection of fluid is frequently used for identification of the epidural space by the loss-of-resistance (LOR) technique. It has been shown that different volumes of saline may affect the subsequent epidural analgesia. Iwama showed that using 10 mL of saline as compared to two mL in patients undergoing elective surgery during lumbar epidural anesthesia with 2% mepivacaine resulted in a greater extent of anesthesia.2 Also, Okutomi et al examined the effect of saline volume on anesthetic levels and quality of thoracic epidural block in patients undergoing upper abdominal surgery. They demonstrated that the block level for cold after mepivacaine 1.5% was proportional to the saline volume injected, whereas the block level for pain was independent of the saline solution.3 Identifying the epidural space by a lost of resistance to air method is thought to increase the incidence of inadequate anesthesia. A randomized study, comparing air versus saline to identify the epidural space in parturients, found a higher incidence of inadequate analgesia in the air group (36% versus 19%).4
In parturients requesting epidural analgesia, a few studies showed that 2- 10ml normal saline giving to epidural space after LOR was obtained reduced the rate of venous puncture and unblock segments to cold and pin prick, but did not improve the visual analog pain scale or reduced the need for supplemental.3,5,6 No study on improvement of unilateral block, patch block and patients' satisfaction in obstetric setting has been found.
We design this study to examine the hypothesis that 10ml epidural normal saline to reduce rate of one-side block, low segmental block, and patch block, and improve quality of labor epidural analgesia/ anesthesia in obstetric population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard labor epidural protocol | Placebo comparator | Procedure: Administration of epidural anesthesia for laborStandard labor epidural protocol |
| 10ml Normal Saline prior to lidocaine | Experimental | Other: Normal Saline |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists class I-II term parturients with singleton vertex presentation in active labor
- Patients who have cervical dilatation between 3 and 7 centimeters
Key exclusion criteria (9 listed)
- • Patients with contraindications to epidural analgesia,
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 |
|---|---|---|
| Normal Saline10ml Normal Saline instilled in the epidural space | Other | 10ml Normal Saline prior to lidocaine |
| Administration of epidural anesthesia for laborStandard procedure | Procedure or surgery | Standard labor epidural protocol |
Primary outcome
improve quality of labor epidural analgesia/ anesthesia in obstetric population.
Time frame: Administration of epidural anesthesia + 2 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
Related trials for Parturients
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Parturients, Accidental Puncture of Dura During Anaesthesia
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Esketamine Combined With Transcutaneous Electrical Acupoint Stimulation on Postoperative Recovery Quality After Elective Cesarean Section
Cesarean Section (MeSH: D002585), Postoperative Pain After Cesarean Section
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Effect of Stress Ball Use on Perioperative Anxiety and Postoperative Pain in Parturients Undergoing Cesarean Section
Postoperative Pain
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Wearable Ultrasound Patch in Parturients
Pregnancy - Labor Monitoring, Labor and Childbirth
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Routine Antiemetic Prophylaxis for Nonfasted Parturients Undergoing Cesarean Sections Under Spinal Anesthesia
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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.
Dongchen Li, MD, PhD principal investigator
UMDNJ-NJMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Normal Saline and Administration of epidural anesthesia for labor in people with Parturients, run by University of Medicine and Dentistry of New Jersey 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 9 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: withdrawn, as of the sponsor's last update on 24 Apr 2015. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
improve quality of labor epidural analgesia/ anesthesia in obstetric population. (time frame: Administration of epidural anesthesia + 2 hours). 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 24 Apr 2015.