Labor PainPhase 3NCT03103100
Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation
A Phase 3 study testing 1% Lidocaine, 0.25% Bupivacaine and Bupivacaine plus Lidocaine in people with Labor Pain, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study will compare and determine the most ideal local anesthetic (LA) solution to activate a labor epidural: lidocaine, bupivacaine, or a combination of bupivacaine plus lidocaine. Read more about this study
- Who is it for?
- Ages 19 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- 1% Lidocaine, 0.25% Bupivacaine and Bupivacaine plus Lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2015to 9 Sep 2019
- Phase
- Phase 3
- 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 19 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant patients over the age of 19 who are scheduled for an induction of labor and request an epidural are eligible for the study
Who cannot join
- age <19
- allergy to the drug or drug class
- preexisting neuropathy
- history of back pain prior to pregnancy or history of back surgery
- history of chronic opioid use
- history of hypertension or hypertensive disorders of pregnancy
- congenital or acquired cardiac disease
- contraindication to epidural placement (patient refusal, severe coagulopathy, infection at site of epidural needle insertion, severe hypovolemia)
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Department of Anesthesiology and Perioperative Medicine
Birmingham, Alabama, 35249
About this study
Official title: Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation: A Prospective, Randomized, Double-Blind Study
This study will compare and determine the most ideal local anesthetic (LA) solution to activate a labor epidural: lidocaine, bupivacaine, or a combination of bupivacaine plus lidocaine.
Read the detailed description
The most common and effective method for controlling labor pains is a local anesthetic (LA) infusion through a lumbar epidural. To achieve adequate pain control during the first stage of labor - onset of contractions to complete cervical dilation - nerve fibers up to the T10 dermatome must be anesthetized. When a patient is in active labor and an epidural catheter is placed, the anesthesiologist must activate the epidural by administering LA through the epidural to promote spread of the LA in the epidural space to anesthetize the nerve fibers involved in the conduction of labor pains. The ideal LA to achieve this goal is one that would allow for the fastest onset to achieve quick pain relief with the fewest side effects.
Two commonly used LA to provide labor analgesia are bupivacaine and lidocaine. When low concentrations - 0.25% bupivacaine and 1% lidocaine - are used for labor analgesia, both of these LA can be administered safely with very little concern of major adverse effects associated with LA toxicity. Given that there is limited and conflicting evidence for the usefulness of the bupivacaine and lidocaine mixture especially as it relates to labor epidural activation, we hope to readdress these questions in an effort to determine whether or not the LA combination offers any distinct advantage over the individual LA. The investigators intend to determine the time it takes to achieve an adequate level (T10) for labor analgesia, the total spread of local anesthetic, and the degree of motor block as these factors will be important in determining the most optimal LA solution to activate a labor epidural. With the results from this study, the investigators hope to recommend a LA solution that will allow for the fastest pain relief in the laboring mother with the fewest side effects.
- Conditions
- Labor Pain
- Being tested
- 1% Lidocaine, 0.25% Bupivacaine, Bupivacaine plus Lidocaine
- Keywords
- Local anesthetic, Labor 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.
1% LidocaineDrug
Also called Lidoderm, Xylocaine, Recticare, Anecream,, Solarcaine, Anestacon, Cutiecaine, Lidocoll,
10 mL of 1% lidocaine
0.25% BupivacaineDrug
Also called Marcaine and Sensorcaine
10 mL of 0.25% bupivacaine
Bupivacaine plus LidocaineDrug
Also called Lidoderm, Xylocaine, Recticare, Anecream, Lmx4, Akten,, Marcaine and Sensorcaine
5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| 1% Lidocaine | Active comparator | Patients randomized into the lidocaine group will receive 10 mL of 1% lidocaine Receives: Drug: 1% Lidocaine |
| 0.25% Bupivacaine | Active comparator | Patients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine Receives: Drug: 0.25% Bupivacaine |
| Bupivacaine plus Lidocaine | Active comparator | Patients randomized into the bupivacaine group will receive 5 mL of 0.25% bupivacaine and 5 mL of 1% lidocaine. Receives: Drug: Bupivacaine plus Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Achieve an Adequate Epidural Level for Labor Analgesia
time it takes to achieve a T10 dermatome level by pinprick. A T10 dermatome level is what is needed to control labor pain.
Measured: Baseline to 1 hour
Secondary outcomes (3)
Number of Patients Who Achieve Adequate Analgesia
The number of patients who received an adequate epidural level of T10 or higher
Measured: Baseline to 1 hour
Degree of Motor Block
degree of motor block which means the amount of weakness in the legs experienced by the participants. this was determined by using the Bromage scale where 4 = greatest amount of motor block or muscle weakness and 0 = the least amount of motor block.
Measured: Baseline to 1 hour
Number of Patients Who Experienced of Maternal Hypotension
Number of patients who experienced maternal hypotension defined as a blood pressure (BP) >20% decline from baseline and need for vasopressor therapy
Measured: Baseline to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start8 Oct 2015
- Primary completion1 Jul 2019
- Study completion9 Sep 2019
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.
- More trials run by University of Alabama at BirminghamThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Powell, University of Alabama at Birmingham
- Investigators
- Mark F Powell, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103100
- Sponsor's protocol ID
- F140903008
- Status last verified
- Aug 2020
- First submitted
- 31 Mar 2017
- Last updated
- 31 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation: A Prospective, Randomized, Double-Blind Study
- ClinicalTrials.gov ID
- NCT03103100
- Acronym / sponsor ID
- F140903008
- Conditions
- Labor Pain
- Keywords
- Local anesthetic, Labor epidural
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 8 Oct 2015 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 6 Apr 2017 (actual)
- Results
- Posted 31 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare and determine the most ideal local anesthetic (LA) solution to activate a labor epidural: lidocaine, bupivacaine, or a combination of bupivacaine plus lidocaine.
Detailed description
The most common and effective method for controlling labor pains is a local anesthetic (LA) infusion through a lumbar epidural. To achieve adequate pain control during the first stage of labor - onset of contractions to complete cervical dilation - nerve fibers up to the T10 dermatome must be anesthetized. When a patient is in active labor and an epidural catheter is placed, the anesthesiologist must activate the epidural by administering LA through the epidural to promote spread of the LA in the epidural space to anesthetize the nerve fibers involved in the conduction of labor pains. The ideal LA to achieve this goal is one that would allow for the fastest onset to achieve quick pain relief with the fewest side effects.
Two commonly used LA to provide labor analgesia are bupivacaine and lidocaine. When low concentrations - 0.25% bupivacaine and 1% lidocaine - are used for labor analgesia, both of these LA can be administered safely with very little concern of major adverse effects associated with LA toxicity. Given that there is limited and conflicting evidence for the usefulness of the bupivacaine and lidocaine mixture especially as it relates to labor epidural activation, we hope to readdress these questions in an effort to determine whether or not the LA combination offers any distinct advantage over the individual LA. The investigators intend to determine the time it takes to achieve an adequate level (T10) for labor analgesia, the total spread of local anesthetic, and the degree of motor block as these factors will be important in determining the most optimal LA solution to activate a labor epidural. With the results from this study, the investigators hope to recommend a LA solution that will allow for the fastest pain relief in the laboring mother with the fewest side effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1% Lidocaine | Active comparator | Drug: 1% LidocainePatients randomized into the lidocaine group will receive 10 mL of 1% lidocaine |
| 0.25% Bupivacaine | Active comparator | Drug: 0.25% BupivacainePatients randomized into the bupivacaine group will receive 10 mL of 0.25% bupivacaine |
| Bupivacaine plus Lidocaine | Active comparator | Drug: Bupivacaine plus LidocainePatients randomized into the bupivacaine group will receive 5 mL of 0.25% bupivacaine and 5 mL of 1% lidocaine. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant patients over the age of 19 who are scheduled for an induction of labor and request an epidural are eligible for the study
Key exclusion criteria (8 listed)
- age <19
- allergy to the drug or drug class
- preexisting neuropathy
- history of back pain prior to pregnancy or history of back surgery
- history of chronic opioid use
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 |
|---|---|---|
| 1% LidocaineAlso: Lidoderm, Xylocaine, Recticare, Anecream,, Solarcaine, Anestacon, Cutiecaine, Lidocoll,10 mL of 1% lidocaine | Drug | 1% Lidocaine |
| 0.25% BupivacaineAlso: Marcaine and Sensorcaine10 mL of 0.25% bupivacaine | Drug | 0.25% Bupivacaine |
| Bupivacaine plus LidocaineAlso: Lidoderm, Xylocaine, Recticare, Anecream, Lmx4, Akten,, Marcaine and Sensorcaine5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine | Drug | Bupivacaine plus Lidocaine |
Primary outcome
Time to Achieve an Adequate Epidural Level for Labor Analgesia
Time frame: Baseline to 1 hour
time it takes to achieve a T10 dermatome level by pinprick. A T10 dermatome level is what is needed to control labor pain.
3 secondary outcomes
Number of Patients Who Achieve Adequate Analgesia
Time frame: Baseline to 1 hour
Degree of Motor Block
Time frame: Baseline to 1 hour
Number of Patients Who Experienced of Maternal Hypotension
Time frame: Baseline to 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Mark F Powell, MD principal investigator
University of Alabama at Birmingham
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 1% Lidocaine, 0.25% Bupivacaine and Bupivacaine plus Lidocaine in people with Labor Pain, run by University of Alabama at Birmingham 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 1 inclusion and 8 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 31 Aug 2020. 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 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?
Yes. Results are posted in the registry (first posted 31 Aug 2020). 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?
Time to Achieve an Adequate Epidural Level for Labor Analgesia (time frame: Baseline to 1 hour). 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 31 Aug 2020.