Labor PainNCT02510287
A Comparison of Epidural Analgesia: Continuous Infusion Versus Programmed Intermittent Boluses
A study testing Bupivacaine and Fentanyl Initial Dose, Bupivacaine and Fentanyl: Continuous Epidural Infusion and Bupivacaine and Fentanyl: Programmed Intermittent Epidural Bolus in people with Labor Pain, run by Fundación Santa Fe de Bogota at 1 site in Colombia.
Trial summary
The analgesic approach in labor can be done in different ways, among which the neuraxial approach has shown the best analgesic results and fetal outcomes. Currently, programmed epidural intermittent bolus has been included in the neuraxial approach for a better distribution of the solution into the epidural space as… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Bupivacaine and Fentanyl Initial Dose, Bupivacaine and Fentanyl: Continuous Epidural Infusion and Bupivacaine and Fentanyl: Programmed Intermittent Epidural Bolus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteColombia
- Study dates
- Jul 2015to May 2016
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- At term pregnancy
- Laboring patients requiring epidural analgesia
Who cannot join
- American Society of Anesthesiologists physical status > or equal than 3
- allergy to local anesthesics
- Neuraxial contraindications
- Hemodynamic instability
- Systemic disease such as diabetes mellitus or hypertension
- Chronic usage of analgesics
- Disease associated to pregnancy such as gestational diabetes, preeclampsia, fetal malformations among others
Trial locations and contacts
1 site in 1 country.
About this study
The analgesic approach in labor can be done in different ways, among which the neuraxial approach has shown the best analgesic results and fetal outcomes. Currently, programmed epidural intermittent bolus has been included in the neuraxial approach for a better distribution of the solution into the epidural space as compared with the continuous infusion strategy. In this study, the investigators seek to compare both strategies in 132 laboring women.
- Conditions
- Labor Pain
- Being tested
- Bupivacaine and Fentanyl Initial Dose, Bupivacaine and Fentanyl: Continuous Epidural Infusion, Bupivacaine and Fentanyl: Programmed Intermittent Epidural Bolus, Rescue Bolus, Lidocaine
- Keywords
- analgesia, epidural, labor pain, patient satisfaction
- Medical subject headings
- Labor Pain, Agnosia, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine and Fentanyl Initial DoseDrug
10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution)
Bupivacaine and Fentanyl: Continuous Epidural InfusionDrug
0.1% bupivacaine and fentanyl 2 mcg / ml (8-12 ml / hour)
Bupivacaine and Fentanyl: Programmed Intermittent Epidural BolusDrug
A 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12ml) bolus will be administered each hour at a rate of 500ml/hour
Rescue BolusDrug
Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered.
LidocaineDrug
If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Epidural Infusion | Active comparator | 1. An initial dose of 10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution) will be given.
2. A continuous infusion of 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12 ml / hour) will then be administered.
3. Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered.
4. If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered. Receives: Drug: Bupivacaine and Fentanyl Initial Dose; Drug: Bupivacaine and Fentanyl: Continuous Epidural Infusion; Drug: Rescue Bolus; Drug: Lidocaine |
| Programmed Intermittent Epidural Bolus | Experimental | 1. An initial dose of 10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution) will be given.
2. A 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12ml) bolus will be administered each hour at a rate of 500ml/hour.
3. Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered.
4. If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered . Receives: Drug: Bupivacaine and Fentanyl Initial Dose; Drug: Bupivacaine and Fentanyl: Programmed Intermittent Epidural Bolus; Drug: Rescue Bolus; Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level in laboring women measured by the Numeric Analog Scale
to compare pain level in each arm once epidural analgesia is applied until birth
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionMay 2016
- Study completionMay 2016
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Santa Fe de Bogota
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leopoldo Ferrer, Fundación Santa Fe de Bogota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510287
- Sponsor's protocol ID
- CCEI-3413-2015
- Status last verified
- May 2016
- First submitted
- 22 Jul 2015
- Last updated
- 20 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Epidural Analgesia: Continuous Infusion Versus Programmed Intermittent Boluses
- ClinicalTrials.gov ID
- NCT02510287
- Acronym / sponsor ID
- CCEI-3413-2015
- Conditions
- Labor Pain
- Keywords
- analgesia, epidural, labor pain, patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Fundación Santa Fe de BogotaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 29 Jul 2015 (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 analgesic approach in labor can be done in different ways, among which the neuraxial approach has shown the best analgesic results and fetal outcomes. Currently, programmed epidural intermittent bolus has been included in the neuraxial approach for a better distribution of the solution into the epidural space as compared with the continuous infusion strategy. In this study, the investigators seek to compare both strategies in 132 laboring women.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Epidural Infusion | Active comparator | Drug: Bupivacaine and Fentanyl Initial Dose, Drug: Bupivacaine and Fentanyl: Continuous Epidural Infusion, Drug: Rescue Bolus, Drug: Lidocaine1. An initial dose of 10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution) will be given. 2. A continuous infusion of 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12 ml / hour) will then be administered. 3. Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered. 4. If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered. |
| Programmed Intermittent Epidural Bolus | Experimental | Drug: Bupivacaine and Fentanyl Initial Dose, Drug: Bupivacaine and Fentanyl: Programmed Intermittent Epidural Bolus, Drug: Rescue Bolus, Drug: Lidocaine1. An initial dose of 10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution) will be given. 2. A 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12ml) bolus will be administered each hour at a rate of 500ml/hour. 3. Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered. 4. If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered . |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- At term pregnancy
- Laboring patients requiring epidural analgesia
Key exclusion criteria (7 listed)
- American Society of Anesthesiologists physical status > or equal than 3
- allergy to local anesthesics
- Neuraxial contraindications
- Hemodynamic instability
- Systemic disease such as diabetes mellitus or hypertension
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 |
|---|---|---|
| Bupivacaine and Fentanyl Initial Dose10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution) | Drug | Continuous Epidural Infusion, Programmed Intermittent Epidural Bolus |
| Bupivacaine and Fentanyl: Continuous Epidural Infusion0.1% bupivacaine and fentanyl 2 mcg / ml (8-12 ml / hour) | Drug | Continuous Epidural Infusion |
| Bupivacaine and Fentanyl: Programmed Intermittent Epidural BolusA 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12ml) bolus will be administered each hour at a rate of 500ml/hour | Drug | Programmed Intermittent Epidural Bolus |
| Rescue BolusUpon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered. | Drug | Continuous Epidural Infusion, Programmed Intermittent Epidural Bolus |
| LidocaineIf needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered. | Drug | Continuous Epidural Infusion, Programmed Intermittent Epidural Bolus |
Primary outcome
Pain level in laboring women measured by the Numeric Analog Scale
Time frame: one year
to compare pain level in each arm once epidural analgesia is applied until birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
Related trials for Labor Pain
Recruiting
The Effect Of Partner-Assısted Rebozo Technıque On Labor Paın And Satısfactıon In Prımary Pregnant Women
Labor Pains
RecruitingPhase 4
Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
Labor Pain
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety
Recruiting
Pain Neuroscience-Based Education for Labor Pain in Pregnant Women
Labor Pain and Anxiety
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine and Fentanyl Initial Dose, Bupivacaine and Fentanyl: Continuous Epidural Infusion and Bupivacaine and Fentanyl: Programmed Intermittent Epidural Bolus in people with Labor Pain, run by Fundación Santa Fe de Bogota at 1 site in Colombia.
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 7 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 20 May 2016. 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 Colombia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain level in laboring women measured by the Numeric Analog Scale (time frame: one year). 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 20 May 2016.