Spinal AnesthesiaPhase 3NCT03110003
Bupivacaine With Epidural Volume Extension
A Phase 3 study testing 10 mg Bupivacaine and 5 mg Bupivacaine in people with Spinal Anesthesia and Epidural; Anesthesia, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
In this study the investigator will address the efficacy of using low dose bupivacaine spinal anesthesia (SA) in combination with epidural volume extension (EVE) for patients undergoing short obstetric procedures. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Spinal Anesthesia, Epidural; Anesthesia
- What is being tested?
- 10 mg Bupivacaine and 5 mg Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2016to 30 Sep 2018
- 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients undergoing short obstetric procedure in the operating room requiring neuraxial anesthesia.
Who cannot join
- coagulopathy
- platelets <80,000
- allergy to local anesthetic or fentanyl
- previous spinal surgery
- spinal or intracranial mass
- history of lower extremity weakness
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 Low-dose Bupivacaine With Epidural Volume Extension to Standard Bupivacaine Dosing for Short Obstetric Procedures: A Prospective, Randomized Study
In this study the investigator will address the efficacy of using low dose bupivacaine spinal anesthesia (SA) in combination with epidural volume extension (EVE) for patients undergoing short obstetric procedures.
Read the detailed description
Due to risks to both the mother and fetus, neuraxial anesthesia - spinal, epidural, or combined spinal-epidural (CSE) - is preferred over general anesthesia for all obstetrical procedures. However, one downside to neuraxial anesthesia is the increased time patients have to stay in the post-anesthesia care unit (PACU) due to residual numbness from the neuraxial block. In this study, the investigators will address the efficacy of using low dose bupivacaine spinal anesthesia (SA) in combination with epidural volume extension (EVE) for patients undergoing short obstetric procedures. This will be accomplished by performing a CSE with: 1) injecting the local anesthesia in the spinal space; 2) injecting sterile saline into the epidural space to help increase the spread of the local anesthesia in the spinal space. The idea is that physicians will be able to use less local anesthetic due to getting a greater spread of medication. This lower amount of local anesthetic will lead to a decreased duration of the spinal block; therefore, it will significantly decrease PACU length of stay. This technique will be compared to our traditional dose of spinal anesthetic without EVE in the CSE. Both groups will have an epidural catheter in place to allow us to give any additional local anesthetic to keep the patient comfortable throughout the procedure if the spinal anesthesia begins to wear off. The aim of this study is to determine if low dose spinal bupivacaine in conjunction with EVE can decrease the PACU recovery time for short obstetric procedures while still providing an adequate surgical block.
- Conditions
- Spinal Anesthesia, Epidural; Anesthesia
- Being tested
- 10 mg Bupivacaine, 5 mg Bupivacaine
- Keywords
- Neuraxial epidural techniques, Combined spinal epidural, Epidural volume extension, Transient Neurologic Symptoms (TNS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 mg BupivacaineDrug
Also called Marcaine and Sensorcaine
10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space
5 mg BupivacaineDrug
Also called Marcaine and Sensorcaine
5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.
| Study group | Role | What they receive |
|---|---|---|
| 10 mg Bupivacaine | Active comparator | Subjects will receive 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl. Receives: Drug: 10 mg Bupivacaine |
| 5 mg Bupivacaine | Active comparator | Subjects will receive 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space. Receives: Drug: 5 mg Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Until PACU Discharge in Minutes
Time from entrance into the PACU until PACU discharge criteria met
Measured: Baseline up to 48 hrs postoperatively
Secondary outcomes (5)
Peak Block Height
Thoracic dermatome level as assessed by pinprick
Measured: Baseline up to 3 hours
Degree of Peak Motor Blockade by Modified Bromage Scale
Motor blockade will be determined by the patient's ability to lift her legs
This is simple scale used to assess motor function in the patients' legs. A numerical value from 0 to 4 is assigned to visual inspection of how well the patient can move her legs. 0=ability to maintain a leg lift for prolonged periods; 1=ability to lift legs briefly; 2=ability to bend knees; 3=ability to wiggle toes; 4=no movement in legs. A score of 0 means complete movement (no blockade) in the legs, whereas a score of 4 means no movement (complete blockade) in the legs.
Measured: Baseline up to 3 hours
Time Elapsed Until Motor Block Regresses to Modified Bromage Score = 0
Time until score of <2 reached on Modified Bromage scale
This is simple scale used to assess motor function in the patients' legs. A numerical value from 0 to 4 is assigned to visual inspection of how well the patient can move her legs. 0=ability to maintain a leg lift for prolonged periods; 1=ability to lift legs briefly; 2=ability to bend knees; 3=ability to wiggle toes; 4=no movement in legs. A score of 0 means complete movement (no blockade) in the legs, whereas a score of 4 means no movement (complete blockade) in the legs. Once the patient received as score of 0, the time ended. Again, 0=ability to maintain a leg lift for prolonged periods.
Measured: Baseline up to 6 hours
Quality of Block as Determined by Subjective Pain Assessment
Determined by any pain reported during surgery and/or the need to supplement through the epidural
Measured: Baseline up to 6 hours
Patient Satisfaction as Determined by a Likert-type Scale
Patient satisfaction of a scale of 1-10
This scale is grade from 1 to 10 with 1 being "highly dissatisfied" with the anesthetic technique and 10 being "highly satisfied." Each patient was asked to rate their experience with the anesthetic technique provide. They could choose any number between 1 and 10. Numbers close to 10 represented a higher satisfaction with the anesthetic technique.
Measured: At 6 hrs postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start27 Jun 2016
- Primary completion1 Dec 2017
- Study completion30 Sep 2018
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 Spinal AnesthesiaStudies 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
- None (open label)
- Enrolment
- 45 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 Powell, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110003
- Sponsor's protocol ID
- F1605020005
- Status last verified
- Nov 2018
- First submitted
- 30 Mar 2017
- Last updated
- 19 Dec 2018
- 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 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Low-dose Bupivacaine With Epidural Volume Extension to Standard Bupivacaine Dosing for Short Obstetric Procedures: A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT03110003
- Acronym / sponsor ID
- F1605020005
- Conditions
- Spinal Anesthesia, Epidural; Anesthesia
- Keywords
- Neuraxial epidural techniques, Combined spinal epidural, Epidural volume extension, Transient Neurologic Symptoms (TNS)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 27 Jun 2016 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Posted 13 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the investigator will address the efficacy of using low dose bupivacaine spinal anesthesia (SA) in combination with epidural volume extension (EVE) for patients undergoing short obstetric procedures.
Detailed description
Due to risks to both the mother and fetus, neuraxial anesthesia - spinal, epidural, or combined spinal-epidural (CSE) - is preferred over general anesthesia for all obstetrical procedures. However, one downside to neuraxial anesthesia is the increased time patients have to stay in the post-anesthesia care unit (PACU) due to residual numbness from the neuraxial block. In this study, the investigators will address the efficacy of using low dose bupivacaine spinal anesthesia (SA) in combination with epidural volume extension (EVE) for patients undergoing short obstetric procedures. This will be accomplished by performing a CSE with: 1) injecting the local anesthesia in the spinal space; 2) injecting sterile saline into the epidural space to help increase the spread of the local anesthesia in the spinal space. The idea is that physicians will be able to use less local anesthetic due to getting a greater spread of medication. This lower amount of local anesthetic will lead to a decreased duration of the spinal block; therefore, it will significantly decrease PACU length of stay. This technique will be compared to our traditional dose of spinal anesthetic without EVE in the CSE. Both groups will have an epidural catheter in place to allow us to give any additional local anesthetic to keep the patient comfortable throughout the procedure if the spinal anesthesia begins to wear off. The aim of this study is to determine if low dose spinal bupivacaine in conjunction with EVE can decrease the PACU recovery time for short obstetric procedures while still providing an adequate surgical block.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 mg Bupivacaine | Active comparator | Drug: 10 mg BupivacaineSubjects will receive 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl. |
| 5 mg Bupivacaine | Active comparator | Drug: 5 mg BupivacaineSubjects will receive 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients undergoing short obstetric procedure in the operating room requiring neuraxial anesthesia.
Key exclusion criteria (6 listed)
- coagulopathy
- platelets <80,000
- allergy to local anesthetic or fentanyl
- previous spinal surgery
- spinal or intracranial mass
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 |
|---|---|---|
| 10 mg BupivacaineAlso: Marcaine and Sensorcaine10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space | Drug | 10 mg Bupivacaine |
| 5 mg BupivacaineAlso: Marcaine and Sensorcaine5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space. | Drug | 5 mg Bupivacaine |
Primary outcome
Time Until PACU Discharge in Minutes
Time frame: Baseline up to 48 hrs postoperatively
Time from entrance into the PACU until PACU discharge criteria met
5 secondary outcomes
Peak Block Height
Time frame: Baseline up to 3 hours
Degree of Peak Motor Blockade by Modified Bromage Scale
Time frame: Baseline up to 3 hours
Time Elapsed Until Motor Block Regresses to Modified Bromage Score = 0
Time frame: Baseline up to 6 hours
Quality of Block as Determined by Subjective Pain Assessment
Time frame: Baseline up to 6 hours
Patient Satisfaction as Determined by a Likert-type Scale
Time frame: At 6 hrs postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Mark 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 10 mg Bupivacaine and 5 mg Bupivacaine in people with Spinal Anesthesia and Epidural; Anesthesia, 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 6 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 19 Dec 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. 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 13 Sep 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?
Time Until PACU Discharge in Minutes (time frame: Baseline up to 48 hrs postoperatively). 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 19 Dec 2018; AzTrials last refreshed its copy on 30 Oct 2026.