Pregnancy RelatedPhase 2NCT03993314
Optimizing Anesthesia for Post Partum Tubal Ligations
A Phase 2 study testing Chloroprocaine and Bupivacaine in people with Pregnancy Related, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
In this study, the investigators will compare CLOROTEKAL® (1% spinal chloroprocaine) to low-dose isobaric bupivacaine using the epidural volume extension (EVE) technique in patients undergoing post-partum tubal ligation (PPBTL). This will be a randomized, double-blinded study. 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
- Pregnancy Related
- What is being tested?
- Chloroprocaine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2019to 3 Dec 2020
- Phase
- Phase 2
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any patient scheduled for a postpartum tubal ligation at the Women and Infants Center will be eligible for the study
Who cannot join
- age less than 18 years old
- allergy to either local anesthetic class (amide or ester)
- contraindication to spinal anesthesia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35223
About this study
Official title: Comparing 1% Spinal Chloroprocaine to Low-dose Bupivacaine Using the Epidural Volume Extension Technique for Post-Partum Tubal Ligation
In this study, the investigators will compare CLOROTEKAL® (1% spinal chloroprocaine) to low-dose isobaric bupivacaine using the epidural volume extension (EVE) technique in patients undergoing post-partum tubal ligation (PPBTL). This will be a randomized, double-blinded study. Patients scheduled for PPBTL at the Women and Infants Center (WIC) will be eligible for enrollment in this study. Outcomes measured will include: ability to achieve an adequate level required for surgery (T6), rate of epidural activation, and duration of the block. The investigators hope to determine the usefulness of each drug using the EVE technique in the setting of PPBTL.
- Conditions
- Pregnancy Related
- Being tested
- Chloroprocaine, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChloroprocaineDrug
Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural
BupivacaineDrug
1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Active comparator | 1 ml 0.5% isobaric bupivacaine (5 mg) + 15 mcg fentanyl intrathecal plus epidural volume extension (EVE) Receives: Drug: Bupivacaine |
| Chloroprocaine | Experimental | 5 ml 1% spinal chloroprocaine (50 mg) intrathecal plus epidural volume extension (EVE) Receives: Drug: Chloroprocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Achieve a Level of Numbness of T6 or Higher
Degree of analgesia is determined by the level of the block. Block level may be T1 (highest level of numbness), T2, T3, T4, T5, T6, T7,T8, T9 , T10, T11, T12, L1, L2, L3, or L4 (lowest level or numbness).
A level of numbness of T6 or higher is required for an adequate surgical block. Participants are classified as having either an adequate level of numbness (T1, T2, T3, T4, T5, or T6) or an inadequate level (T7,T8, T9 , T10, T11, T12, L1, L2, L3, or L4).
Measured: 10 minutes after spinal injection
Level of Numbness
The degree to which participants experience analgesia. Degree of analgesia is determined by the level of the block. Block level may be T1 (highest level of numbness), T2, T3, T4, T5, T6, T7,T8, T9 , T10, T11, T12, L1, L2, L3, or L4 (lowest level or numbness).
Participants are assigned a numerical score according to level of the block. Numerical scores were assigned so that a higher score indicates better outcome (i.e., greater level of numbness):
T1 = 16 points; T2 = 15 points; T3 = 14 points; T4 = 13 points; T5 = 12 points; T6 = 11 points; T7 = 10 points; T8 = 9 points; T9 = 8 points; T10 = 7 points; T11 = 6 points; T12 = 5 points; L1 = 4 points; L2 = 3 points; L3 = 2 points; L4 = 1 point
Measured: 10 minutes after spinal injection
Secondary outcomes (5)
Epidural Activation
Number of patients who required epidural activation
Measured: Day of surgery
Supplemental Intravenous Sedation or General Anesthesia
Number of patients who required supplemental intravenous sedation or general anesthesia
Measured: Day of surgery
Modified Bromage Score at 10 Minutes Post-injection
The modified Bromage score is an ordinal scale ranging from 0 to 4 with higher values indicating greater levels of numbness.
0 = ability to maintain leg lift for prolonged period; 1 = ability to lift legs briefly; 2 = ability to bend knees; 3 = ability to wiggle toes; 4 = no movement of lower extremities
Measured: 10 minutes after spinal injection
Modified Bromage Score 60 Minutes After Intrathecal Injection
The modified Bromage score is an ordinal scale ranging from 0 to 4 with higher values indicating greater levels of numbness.
0 = ability to maintain leg lift for prolonged period; 1 = ability to lift legs briefly; 2 = ability to bend knees; 3 = ability to wiggle toes; 4 = no movement of lower extremities
Measured: 60 minutes after spinal injection
Time to PACU Discharge
Time required for readiness for discharge from Post Anesthesia Care Unit (PACU)
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start13 Aug 2019
- Primary completion3 Dec 2020
- Study completion3 Dec 2020
Why it stopped: Lack of recruitment due to COVID-19 pandemic; chloroprocaine shortage
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 Pregnancy RelatedStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 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
- NCT03993314
- Sponsor's protocol ID
- IRB-300003361
- Status last verified
- Dec 2021
- First submitted
- 17 Jun 2019
- Last updated
- 17 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing 1% Spinal Chloroprocaine to Low-dose Bupivacaine Using the Epidural Volume Extension Technique for Post-Partum Tubal Ligation
- ClinicalTrials.gov ID
- NCT03993314
- Acronym / sponsor ID
- IRB-300003361
- Conditions
- Pregnancy Related
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment due to COVID-19 pandemic; chloroprocaine shortage
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 3 Dec 2020 (actual)
- Study completion
- 3 Dec 2020 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Posted 17 Dec 2021
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 investigators will compare CLOROTEKAL® (1% spinal chloroprocaine) to low-dose isobaric bupivacaine using the epidural volume extension (EVE) technique in patients undergoing post-partum tubal ligation (PPBTL). This will be a randomized, double-blinded study. Patients scheduled for PPBTL at the Women and Infants Center (WIC) will be eligible for enrollment in this study. Outcomes measured will include: ability to achieve an adequate level required for surgery (T6), rate of epidural activation, and duration of the block. The investigators hope to determine the usefulness of each drug using the EVE technique in the setting of PPBTL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Active comparator | Drug: Bupivacaine1 ml 0.5% isobaric bupivacaine (5 mg) + 15 mcg fentanyl intrathecal plus epidural volume extension (EVE) |
| Chloroprocaine | Experimental | Drug: Chloroprocaine5 ml 1% spinal chloroprocaine (50 mg) intrathecal plus epidural volume extension (EVE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient scheduled for a postpartum tubal ligation at the Women and Infants Center will be eligible for the study
Key exclusion criteria (3 listed)
- age less than 18 years old
- allergy to either local anesthetic class (amide or ester)
- contraindication to spinal anesthesia
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 |
|---|---|---|
| ChloroprocaineAdding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural | Drug | Chloroprocaine |
| Bupivacaine1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural | Drug | Bupivacaine |
Primary outcome
Number of Patients Who Achieve a Level of Numbness of T6 or Higher
Time frame: 10 minutes after spinal injection
Degree of analgesia is determined by the level of the block. Block level may be T1 (highest level of numbness), T2, T3, T4, T5, T6, T7,T8, T9 , T10, T11, T12, L1, L2, L3, or L4 (lowest level or numbness). A level of numbness of T6 or higher is required for an adequate surgical block. Participants are classified as having either an adequate level of numbness (T1, T2, T3, T4, T5, or T6) or an inadequate level (T7,T8, T9 , T10, T11, T12, L1, L2, L3, or L4).
Level of Numbness
Time frame: 10 minutes after spinal injection
The degree to which participants experience analgesia. Degree of analgesia is determined by the level of the block. Block level may be T1 (highest level of numbness), T2, T3, T4, T5, T6, T7,T8, T9 , T10, T11, T12, L1, L2, L3, or L4 (lowest level or numbness). Participants are assigned a numerical score according to level of the block. Numerical scores were assigned so that a higher score indicates better outcome (i.e., greater level of numbness): T1 = 16 points; T2 = 15 points; T3 = 14 points; T4 = 13 points; T5 = 12 points; T6 = 11 points; T7 = 10 points; T8 = 9 points; T9 = 8 points; T10 = 7 points; T11 = 6 points; T12 = 5 points; L1 = 4 points; L2 = 3 points; L3 = 2 points; L4 = 1 point
5 secondary outcomes
Epidural Activation
Time frame: Day of surgery
Supplemental Intravenous Sedation or General Anesthesia
Time frame: Day of surgery
Modified Bromage Score at 10 Minutes Post-injection
Time frame: 10 minutes after spinal injection
Modified Bromage Score 60 Minutes After Intrathecal Injection
Time frame: 60 minutes after spinal injection
Time to PACU Discharge
Time frame: Day of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- 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 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 2 study testing Chloroprocaine and Bupivacaine in people with Pregnancy Related, 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 3 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: stopped early, as of the sponsor's last update on 17 Dec 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 17 Dec 2021). 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?
Number of Patients Who Achieve a Level of Numbness of T6 or Higher (time frame: 10 minutes after spinal injection). The study lists 2 primary outcomes in all. 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 17 Dec 2021.