Anesthetic, Sedative or Analgesic Complications in Labor or DeliveryPhase 3NCT02004899
Trial of Onset of Epidural Pain Relief With Low Dose Bupivacaine and Different Doses of Fentanyl in Laboring Women
A Phase 3 study testing Fentanyl in people with Anesthetic, Sedative or Analgesic Complications in Labor or Delivery, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Epidural analgesia is the most effective form of labor pain relief. Low doses of local anesthetic (freezing solutions) in combination with opioids (narcotics) are commonly used as epidural solutions to provide pain relief. 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
- Anesthetic, Sedative or Analgesic Complications in Labor or Delivery
- What is being tested?
- Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2013to May 2015
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status 1 or 2
- Pregnant women in early labor (cervical dilation <5cm)
- Singleton fetuses
- Gestational age more than 36 weeks
- Normal fetal heart rate tracing
Who cannot join
- Severe pre-ecclampsia
- Antepartum hemorrhage
- ASA >3
- Chronic pain
- Substance abuse
- Language barrier between patient and investigator
Show all 10Show fewer
- Contraindications to epidural analgesia
- Allergies to local anesthetics or fentanyl
- Morbid obesity
- Previous administration of opioid analgesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Onset of Labor Epidural Analgesia With Low Dose Bupivacaine and Different Doses of Fentanyl: a Randomized Double Blinded Clinical Trial.
Epidural analgesia is the most effective form of labor pain relief. Low doses of local anesthetic (freezing solutions) in combination with opioids (narcotics) are commonly used as epidural solutions to provide pain relief. Low dose local anesthetic solutions with opioids for labor have been shown to decrease motor block (leg weakness or temporary paralysis), without affecting labor pain relief. However, onset of pain relief can be delayed with these low dose solutions. The standard epidural solution used at Victoria Hospital is a low dose of local anesthetic called bupivacaine mixed with fentanyl, an opioid, for labor epidural pain relief.
There is some evidence that the addition of more fentanyl to the epidural bolus dose of bupivacaine at the start of labor epidural analgesia can speed onset of pain relief. Both medications are safe for you and your baby.
Read more
This study will investigate whether the addition of different doses of fentanyl (20 mcg, 50 mcg and 100 mcg) to the epidural bolus dose speeds onset of pain relief.
The study hypothesis is that the onset of epidural labor analgesia will be shortest with the larger fentanyl epidural bolus.
- Being tested
- Fentanyl
- Keywords
- Labor epidural analgesia, Fentanyl, Bupivacaine, Onset
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called Duragesic, Actiq
After obtaining informed consent, patients are randomized into one of two treatment groups or a control group by a computer generated random number table. After confirmation of epidural placement following test dose administration, a loading dose of 10 ml 0.08% Bupivacaine containing 20 mcg Fentanyl is administered after adding 1.6 ml 0.9% NaCl (Sodium Chloride) in the control group (F20).
| Study group | Role | What they receive |
|---|---|---|
| F20 | Active comparator | Patients randomized to this arm of the study receive 20 mcg fentanyl and 8 mg bupivacaine as their epidural loading dose Receives: Drug: Fentanyl |
| F50 | Experimental | Patients randomized to this arm of the study receive 50 mcg fentanyl with 8 mg bupivacaine as their epidural loading dose Receives: Drug: Fentanyl |
| F100 | Experimental | Patients randomized to this arm of the study receive 100 mcg fentanyl and 8 mg bupivacaine as their epidural loading dose Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time, in minutes, since completion of epidural bolus to the first painless contraction
A painless contraction = verbal Numeric Pain Rating Scale less than or equal to 3/10
Measured: Time since epidural bolus dose administration (At 1 and 5 minutes )
Secondary outcomes (15)
Sensory block height to ice
Measured: 30 minutes after epidural bolus dose
Pruritis
Pruritus will be measured using a 4-point scale, where 0 is none, 1 is mild, 2 is moderate, and 3 is severe.
Measured: 30 minutes after epidural bolus dose
Nausea
Nausea will be measured using a 4-point scale, where 0 is none, 1 is mild, 2 is moderate, and 3 is severe.
Measured: 30 minutes after epidural bolus dose
Maternal sedation
Maternal sedation will be measured using a 5-point scale where 0 is wide awake, 1 is mildly drowsy, 2 is very drowsy, 3 is asleep but rousable, and 4 is somnolent.
Measured: 30 minutes after epidural bolus dose
Hypotension
Hypotension is defined as a decrease in systolic blood pressure by 30% or more, or less than 90 mmHg. It is treated with intravenous ephedrine.
Measured: 30 minutes after epidural bolus dose
Motor block
Motor block will be assessed using a modified Bromage score (0 = ability to move hips, ankles, and knees, 1 = inability to raise extended leg, 2 = inability to flex knee, and 3 = inability to flex ankle, foot or knee).
Measured: 30 minutes after epidural bolus dose
Time, in minutes, from epidural bolus dose to use of patient controlled epidural demand dose
time after epidural loading dose at which patient uses Patient Controlled Epidural Analgesia administered bolus
Measured: Estimated time frame 1 hour
Patient satisfaction of analgesia
Patient satisfaction of analgesia will be measured using a 5-point scale where 0 is completely dissatisfied, 1 is somewhat dissatisfied, 2 is neutral, 3 is somewhat satisfied, and 4 is completely satisfied.
Measured: 30 minutes from epidural bolus dose
Incidence of failed analgesia
Patients who have a verbal Numeric Rating Scale score greater than 3/10 after 30 minutes of epidural bolus dose will be deemed a failure.
Measured: 30 minutes after epidural bolus dose
Incidence of fetal bradycardia
Measured: Estimated time frame 24 hours
Time, in minutes, from completion of epidural test dose to delivery
Measured: Estimated time frame 24 hours
Type of delivery
Measured: Estimated time frame 24 hours
Fetal birth weight
Measured: Estimated time frame 24 hours
Neonatal Apgar scores
Measured: At 1 and 5 minutes post-delivery
Breastfeeding
Has breastfeeding been established at 24 hours post-delivery?
Measured: 24 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionOct 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthetic, Sedative or Analgesic Complications in Labor or DeliveryStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Responsible party
- Principal investigator, Indu Singh, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Indu Singh, Principal investigator, Schulich School of Medicine and Dentistry/Anaesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004899
- Sponsor's protocol ID
- 104456
- Status last verified
- May 2016
- First submitted
- 26 Nov 2013
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: IPD will not be available
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onset of Labor Epidural Analgesia With Low Dose Bupivacaine and Different Doses of Fentanyl: a Randomized Double Blinded Clinical Trial.
- ClinicalTrials.gov ID
- NCT02004899
- Acronym / sponsor ID
- 104456
- Keywords
- Labor epidural analgesia, Fentanyl, Bupivacaine, Onset
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Study start
- Dec 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 9 Dec 2013 (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.
Epidural analgesia is the most effective form of labor pain relief. Low doses of local anesthetic (freezing solutions) in combination with opioids (narcotics) are commonly used as epidural solutions to provide pain relief. Low dose local anesthetic solutions with opioids for labor have been shown to decrease motor block (leg weakness or temporary paralysis), without affecting labor pain relief. However, onset of pain relief can be delayed with these low dose solutions. The standard epidural solution used at Victoria Hospital is a low dose of local anesthetic called bupivacaine mixed with fentanyl, an opioid, for labor epidural pain relief.
There is some evidence that the addition of more fentanyl to the epidural bolus dose of bupivacaine at the start of labor epidural analgesia can speed onset of pain relief. Both medications are safe for you and your baby.
This study will investigate whether the addition of different doses of fentanyl (20 mcg, 50 mcg and 100 mcg) to the epidural bolus dose speeds onset of pain relief.
The study hypothesis is that the onset of epidural labor analgesia will be shortest with the larger fentanyl epidural bolus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| F20 | Active comparator | Drug: FentanylPatients randomized to this arm of the study receive 20 mcg fentanyl and 8 mg bupivacaine as their epidural loading dose |
| F50 | Experimental | Drug: FentanylPatients randomized to this arm of the study receive 50 mcg fentanyl with 8 mg bupivacaine as their epidural loading dose |
| F100 | Experimental | Drug: FentanylPatients randomized to this arm of the study receive 100 mcg fentanyl and 8 mg bupivacaine as their epidural loading dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- American Society of Anesthesiologists (ASA) physical status 1 or 2
- Pregnant women in early labor (cervical dilation <5cm)
- Singleton fetuses
- Gestational age more than 36 weeks
- Normal fetal heart rate tracing
Key exclusion criteria (10 listed)
- Severe pre-ecclampsia
- Antepartum hemorrhage
- ASA >3
- Chronic pain
- Substance abuse
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 |
|---|---|---|
| FentanylAlso: Duragesic, ActiqAfter obtaining informed consent, patients are randomized into one of two treatment groups or a control group by a computer generated random number table. After confirmation of epidural placement following test dose administration, a loading dose of 10 ml 0.08% Bupivacaine containing 20 mcg Fentanyl is administered after adding 1.6 ml 0.9% NaCl (Sodium Chloride) in the control group (F20). | Drug | F100, F20, F50 |
Primary outcome
The time, in minutes, since completion of epidural bolus to the first painless contraction
Time frame: Time since epidural bolus dose administration (At 1 and 5 minutes )
A painless contraction = verbal Numeric Pain Rating Scale less than or equal to 3/10
15 secondary outcomes
Sensory block height to ice
Time frame: 30 minutes after epidural bolus dose
Pruritis
Time frame: 30 minutes after epidural bolus dose
Nausea
Time frame: 30 minutes after epidural bolus dose
Maternal sedation
Time frame: 30 minutes after epidural bolus dose
Hypotension
Time frame: 30 minutes after epidural bolus dose
Motor block
Time frame: 30 minutes after epidural bolus dose
Time, in minutes, from epidural bolus dose to use of patient controlled epidural demand dose
Time frame: Estimated time frame 1 hour
Patient satisfaction of analgesia
Time frame: 30 minutes from epidural bolus dose
Incidence of failed analgesia
Time frame: 30 minutes after epidural bolus dose
Incidence of fetal bradycardia
Time frame: Estimated time frame 24 hours
Time, in minutes, from completion of epidural test dose to delivery
Time frame: Estimated time frame 24 hours
Type of delivery
Time frame: Estimated time frame 24 hours
Fetal birth weight
Time frame: Estimated time frame 24 hours
Neonatal Apgar scores
Time frame: At 1 and 5 minutes post-delivery
Breastfeeding
Time frame: 24 hours after delivery
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 12 May 2016.
- Individual participant dataSharing planned: No. IPD will not be available
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.
Indu Singh principal investigator
Schulich School of Medicine and Dentistry/Anaesthesia
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 Fentanyl in people with Anesthetic, Sedative or Analgesic Complications in Labor or Delivery, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 10 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 12 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 Canada. 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 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 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?
The time, in minutes, since completion of epidural bolus to the first painless contraction (time frame: Time since epidural bolus dose administration (At 1 and 5 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 12 May 2016.