Anesthesia, LocalNCT03779568
ED50 and ED95 of Isobaric Bupivacaine for Post-Partum Bilateral Tubal Ligation
A study testing Dose adjustment of bupivacaine in people with Anesthesia, Local, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Spinal anesthesia is one of the preferred anesthetic techniques for post-partum bilateral tubal ligation (PBTL). Bupivacaine is the most commonly used local anesthetic for neuraxial anesthesia for post-partum tubal ligation. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Dose adjustment of bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2019to 9 Apr 2020
- Phase
- Interventional
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and older
- Patients undergoing elective post-partum bilateral tubal ligation after vaginal delivery
- Patients receiving spinal epidural anesthesia with combination of bupivacaine and fentanyl
Who cannot join
- American Society of Anesthesiologists physical status score >3,
- Contraindications to neuraxial analgesia
- Patients in whom a combined spinal epidural cannot be performed
- Body mass index >40 kg/m2
- Allergy or hypersensitivity to local anesthetics and fentanyl
- Severe liver, kidney or respiratory disease.
- Inability to understand the study protocol
- Refusal to provide written consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of ED50 and ED95 of Isobaric Bupivacaine for Post-Partum Bilateral Tubal Ligation
Spinal anesthesia is one of the preferred anesthetic techniques for post-partum bilateral tubal ligation (PBTL). Bupivacaine is the most commonly used local anesthetic for neuraxial anesthesia for post-partum tubal ligation. Typically, hyperbaric bupivacaine would be injected into the spinal (intrathecal) space via a spinal needle; however, ongoing medication shortages have resulted in limited availability on a local and national level. One proposed alternative is isobaric bupivacaine; however, studies investigating its use for post-partum bilateral tubal ligation are limited.
The purpose of this prospective study is to determine the minimal effective dose (ED50 and ED95) of isobaric bupivacaine for adequate anesthesia during post-partum tubal ligation after vaginal delivery.
Read the detailed description
This prospective study proposes to enroll 40 post-partum women who are undergoing elective post-partum bilateral tubal ligation. The patient will be positioned sitting, and combined spinal anesthesia will be performed at L2-3 or L3-4 level. The presence of an epidural catheter enables the provider to supplement the spinal anesthetic if required. The starting dose of isobaric bupivacaine will be 10 mg based on prior similar studies1,4 and our institution's current practice. The dose of intrathecal isobaric bupivacaine was decided by using the up-down sequential method.
The motor block will be graded by a modified Bromage score: Score 1 = complete block, unable to move feet or knees; 2 = almost complete block, able to move feet only; 3 = partial block, just able to move knees; 4 = detectable weakness of hip flexion while supine, full flexion of knees; 5 = no detectable weakness of hip flexion while supine; and 6 = able to perform partial knee bend. The score of 1 or 2 within 10-15 minutes of injection will be evaluated as successful motor block.
The success of the sensory spinal block will be noted when bilateral T6 sensory level to pinprick is attained after 10 mins from the intrathecal drug administration, this is in accordance with previous studies1.
If spinal anesthesia is inadequate, the epidural catheter will be dosed up for supplementation. All observations, including block characteristics and the associated outcome (i.e., adequate or inadequate block), will be evaluated by a dedicated anesthesia provider.
Intraoperative adverse effects, such as hypotension, bradycardia, nausea, or vomiting, pruritus, or shivering were noted. Hypotension is defined as a decrease of more than 20% in basal systolic blood pressure within 30 minutes of intrathecal injection. The management of blood pressure including dose of pressor: phenylephrine and ephedrine will be at the discretion of the attending anesthesiologist. The use of pressor and anti-emetics will also be recorded.
The study will be take place in standard clinical context. The study does not deviate from our current practice, which includes the use of combined spinal anesthesia where the epidural catheter is available if supplemental local anesthetic is required.
- Conditions
- Anesthesia, Local
- Being tested
- Dose adjustment of bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose adjustment of bupivacaineOther
Also called Spinal bupivacaine dose adjustment
Spinal bupivacaine dose will be adjusted according to previous patient experience.
| Study group | Role | What they receive |
|---|---|---|
| Dose adjustment of bupivacaine | Experimental | Patient will receive isobaric bupivacaine based on previous patient experience. Receives: Other: Dose adjustment of bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success or failure of the intrathecal block
The score of 1 or 2 within 10-15 minutes of injection will be evaluated as successful motor block.
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start25 Feb 2019
- Primary completion17 Jun 2019
- Study completion9 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seema Dave, MPH, Study chair, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779568
- Sponsor's protocol ID
- STU 082018-026
- Status last verified
- May 2020
- First submitted
- 17 Dec 2018
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of ED50 and ED95 of Isobaric Bupivacaine for Post-Partum Bilateral Tubal Ligation
- ClinicalTrials.gov ID
- NCT03779568
- Acronym / sponsor ID
- STU 082018-026
- Conditions
- Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 17 Jun 2019 (actual)
- Study completion
- 9 Apr 2020 (actual)
- First posted
- 19 Dec 2018 (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.
Spinal anesthesia is one of the preferred anesthetic techniques for post-partum bilateral tubal ligation (PBTL). Bupivacaine is the most commonly used local anesthetic for neuraxial anesthesia for post-partum tubal ligation. Typically, hyperbaric bupivacaine would be injected into the spinal (intrathecal) space via a spinal needle; however, ongoing medication shortages have resulted in limited availability on a local and national level. One proposed alternative is isobaric bupivacaine; however, studies investigating its use for post-partum bilateral tubal ligation are limited.
The purpose of this prospective study is to determine the minimal effective dose (ED50 and ED95) of isobaric bupivacaine for adequate anesthesia during post-partum tubal ligation after vaginal delivery.
Detailed description
This prospective study proposes to enroll 40 post-partum women who are undergoing elective post-partum bilateral tubal ligation. The patient will be positioned sitting, and combined spinal anesthesia will be performed at L2-3 or L3-4 level. The presence of an epidural catheter enables the provider to supplement the spinal anesthetic if required. The starting dose of isobaric bupivacaine will be 10 mg based on prior similar studies1,4 and our institution's current practice. The dose of intrathecal isobaric bupivacaine was decided by using the up-down sequential method.
The motor block will be graded by a modified Bromage score: Score 1 = complete block, unable to move feet or knees; 2 = almost complete block, able to move feet only; 3 = partial block, just able to move knees; 4 = detectable weakness of hip flexion while supine, full flexion of knees; 5 = no detectable weakness of hip flexion while supine; and 6 = able to perform partial knee bend. The score of 1 or 2 within 10-15 minutes of injection will be evaluated as successful motor block.
The success of the sensory spinal block will be noted when bilateral T6 sensory level to pinprick is attained after 10 mins from the intrathecal drug administration, this is in accordance with previous studies1.
If spinal anesthesia is inadequate, the epidural catheter will be dosed up for supplementation. All observations, including block characteristics and the associated outcome (i.e., adequate or inadequate block), will be evaluated by a dedicated anesthesia provider.
Intraoperative adverse effects, such as hypotension, bradycardia, nausea, or vomiting, pruritus, or shivering were noted. Hypotension is defined as a decrease of more than 20% in basal systolic blood pressure within 30 minutes of intrathecal injection. The management of blood pressure including dose of pressor: phenylephrine and ephedrine will be at the discretion of the attending anesthesiologist. The use of pressor and anti-emetics will also be recorded.
The study will be take place in standard clinical context. The study does not deviate from our current practice, which includes the use of combined spinal anesthesia where the epidural catheter is available if supplemental local anesthetic is required.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose adjustment of bupivacaine | Experimental | Other: Dose adjustment of bupivacainePatient will receive isobaric bupivacaine based on previous patient experience. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and older
- Patients undergoing elective post-partum bilateral tubal ligation after vaginal delivery
- Patients receiving spinal epidural anesthesia with combination of bupivacaine and fentanyl
Key exclusion criteria (8 listed)
- American Society of Anesthesiologists physical status score >3,
- Contraindications to neuraxial analgesia
- Patients in whom a combined spinal epidural cannot be performed
- Body mass index >40 kg/m2
- Allergy or hypersensitivity to local anesthetics and fentanyl
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 |
|---|---|---|
| Dose adjustment of bupivacaineAlso: Spinal bupivacaine dose adjustmentSpinal bupivacaine dose will be adjusted according to previous patient experience. | Other | Dose adjustment of bupivacaine |
Primary outcome
Success or failure of the intrathecal block
Time frame: Perioperative
The score of 1 or 2 within 10-15 minutes of injection will be evaluated as successful motor block.
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 19 May 2020.
- 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.
Seema Dave, MPH study chair
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dose adjustment of bupivacaine in people with Anesthesia, Local, run by University of Texas Southwestern Medical Center 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 3 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 19 May 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.
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?
Success or failure of the intrathecal block (time frame: Perioperative). 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 May 2020.