PainPhase 4NCT05017584
ED90 of 0.75% Bupivacaine for Bilateral Tubal Ligation (BTL)
A Phase 4 study testing Hyperbaric bupivacaine in people with Pain, run by Duke University.
Trial summary
The purpose of this study is to determine the dose of bupivacaine that provides effective pain management in 90% (ED90) of patients undergoing bilateral tubal ligation. This will guide anesthesiologists on the most effective dose to minimize intraoperative pain during this procedure. 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
- Pain
- What is being tested?
- Hyperbaric bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to 1 Jan 2024
- Phase
- Phase 4
- 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
- ≥ 18 years of age
- American Society of Anesthesiology class II or III
- bilateral tubal ligation
Who cannot join
- patient refusal
- BMI ≥ 50 kg/m2
- American Society of Anesthesiology class IV or above
- contraindication to neuraxial anesthesia
- allergy to bupivacaine
About this study
Official title: Determining the ED90 for Intrathecal 0.75% Hyperbaric Bupivacaine for Bilateral Tubal Ligation
The purpose of this study is to determine the dose of bupivacaine that provides effective pain management in 90% (ED90) of patients undergoing bilateral tubal ligation. This will guide anesthesiologists on the most effective dose to minimize intraoperative pain during this procedure. The goal is to make women as comfortable as possible when they undergo this procedure while also minimizing the amount of time they are required to remain in the hospital afterwards for monitoring.
- Conditions
- Pain
- Being tested
- Hyperbaric bupivacaine
- Keywords
- Tubal ligation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric bupivacaineDrug
The dose for the first subject (A#X) will be 12 mg 0.75% hyperbaric bupivacaine. Two possible outcomes will be recorded: satisfactory or unsatisfactory anesthesia which is determined by occurrence of intraoperative pain and the need for intraoperative analgesia supplementation. Satisfactory analgesia will be defined as a sensory block to the T8 dermatome and the patient shall require no further supplementation for discomfort during her procedure. Unsatisfactory analgesia will be defined as a block not achieving a T8 dermatomal level or when a patient requests additional medication for discomfort at any time during her procedure.
The dose for the next (A#X+1) will be adjusted based on the outcome from previous subjects respectively using up-down sequential allocation method with a biased-coin design. This process will continue in similar fashion with dose adjustments for next subjects to be based on outcome from subjects immediately prior.
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric bupivacaine 10.5mg | Experimental | Not described Receives: Drug: Hyperbaric bupivacaine |
| Hyperbaric bupivacaine 12mg | Experimental | Not described Receives: Drug: Hyperbaric bupivacaine |
| Hyperbaric bupivacaine 13.5mg | Experimental | Not described Receives: Drug: Hyperbaric bupivacaine |
| Hyperbaric bupivacaine 15mg | Experimental | Not described Receives: Drug: Hyperbaric bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose (in mg) of intrathecal 0.75% hyperbaric bupivacaine that provides effective analgesia in 90% of patients undergoing bilateral tubal ligation as measured by patient reported effectiveness.
Measured: End of study, up to 2 years
Secondary outcomes (7)
Numerical Pain Rating Scale (NPRS) during surgery
Pain rating 0-10 as outlined by the NPRS by patient during procedure, in the post-anesthesia care unit, and overall at discharge
Measured: End of study, up to 2 years
Side effects
Incidence of side effects intra-operatively
Measured: End of study, up to 2 years
Nausea
Presence of absence of nausea
Measured: End of study, up to 2 years
Vomiting
Presence of absence of vomiting
Measured: End of study, up to 2 years
Itching
Presence of absence of itching
Measured: End of study, up to 2 years
Vasopressor use
Number of participants requiring the of vasopressors (phenylephrine and ephedrine). Indicated for blood pressure drops greater than 15% below baseline or < 100mm Hg systolic.
Measured: End of study, up to 2 years
Patient satisfaction
Overall patient satisfaction at discharge as measured by patient report. This will be obtained using a scale of 1-5 where 1 = very unsatisfied, 2 = unsatisfied, 3 = neither unsatisfied or satisfied, 4 = satisfied, and 5 = very satisfied
Measured: End of study, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study startJan 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Why it stopped: Study halted prematurely, prior to enrollment of first participant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cameron Taylor, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017584
- Sponsor's protocol ID
- Pro00109119
- Status last verified
- May 2022
- First submitted
- 3 Aug 2021
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the ED90 for Intrathecal 0.75% Hyperbaric Bupivacaine for Bilateral Tubal Ligation
- ClinicalTrials.gov ID
- NCT05017584
- Acronym / sponsor ID
- Pro00109119
- Conditions
- Pain
- Keywords
- Tubal ligation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study halted prematurely, prior to enrollment of first participant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 24 Aug 2021 (actual)
- 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 purpose of this study is to determine the dose of bupivacaine that provides effective pain management in 90% (ED90) of patients undergoing bilateral tubal ligation. This will guide anesthesiologists on the most effective dose to minimize intraoperative pain during this procedure. The goal is to make women as comfortable as possible when they undergo this procedure while also minimizing the amount of time they are required to remain in the hospital afterwards for monitoring.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric bupivacaine 10.5mg | Experimental | Drug: Hyperbaric bupivacaine |
| Hyperbaric bupivacaine 12mg | Experimental | Drug: Hyperbaric bupivacaine |
| Hyperbaric bupivacaine 13.5mg | Experimental | Drug: Hyperbaric bupivacaine |
| Hyperbaric bupivacaine 15mg | Experimental | Drug: Hyperbaric bupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years of age
- American Society of Anesthesiology class II or III
- bilateral tubal ligation
Key exclusion criteria (5 listed)
- patient refusal
- BMI ≥ 50 kg/m2
- American Society of Anesthesiology class IV or above
- contraindication to neuraxial anesthesia
- allergy to bupivacaine
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 |
|---|---|---|
| Hyperbaric bupivacaineThe dose for the first subject (A#X) will be 12 mg 0.75% hyperbaric bupivacaine. Two possible outcomes will be recorded: satisfactory or unsatisfactory anesthesia which is determined by occurrence of intraoperative pain and the need for intraoperative analgesia supplementation. Satisfactory analgesia will be defined as a sensory block to the T8 dermatome and the patient shall require no further supplementation for discomfort during her procedure. Unsatisfactory analgesia will be defined as a block not achieving a T8 dermatomal level or when a patient requests additional medication for discomfort at any time during her procedure. The dose for the next (A#X+1) will be adjusted based on the outcome from previous subjects respectively using up-down sequential allocation method with a biased-coin design. This process will continue in similar fashion with dose adjustments for next subjects to be based on outcome from subjects immediately prior. | Drug | Hyperbaric bupivacaine 10.5mg, Hyperbaric bupivacaine 12mg, Hyperbaric bupivacaine 13.5mg, Hyperbaric bupivacaine 15mg |
Primary outcome
Dose (in mg) of intrathecal 0.75% hyperbaric bupivacaine that provides effective analgesia in 90% of patients undergoing bilateral tubal ligation as measured by patient reported effectiveness.
Time frame: End of study, up to 2 years
7 secondary outcomes
Numerical Pain Rating Scale (NPRS) during surgery
Time frame: End of study, up to 2 years
Side effects
Time frame: End of study, up to 2 years
Nausea
Time frame: End of study, up to 2 years
Vomiting
Time frame: End of study, up to 2 years
Itching
Time frame: End of study, up to 2 years
Vasopressor use
Time frame: End of study, up to 2 years
Patient satisfaction
Time frame: End of study, up to 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- 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.
Cameron Taylor, MD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyperbaric bupivacaine in people with Pain, run by Duke University.
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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Dose (in mg) of intrathecal 0.75% hyperbaric bupivacaine that provides effective analgesia in 90% of patients undergoing bilateral tubal ligation as measured by patient reported effectiveness. (time frame: End of study, up to 2 years). 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 27 May 2022.