Pain, PostoperativeEarly Phase 1NCT04157075
Intra-operative Uterosacral Ligament Bupivacaine Injection During Minimally Invasive Hysterectomy
A Early Phase 1 study testing Bupivacaine in people with Pain, Postoperative and Opioid Use, run by Johns Hopkins University at 2 sites in United States.
Trial summary
This is proof of concept, phase I randomized controlled trial studying a short acting non-opioid anesthetic, bupivacaine to improve post-operative pain in gynecologic surgery patients. 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, Postoperative, Opioid Use
- What is being tested?
- Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Mar 2021to 15 Oct 2022
- Phase
- Early Phase 1
- 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
- Women over the age of 18 years old
- undergoing benign minimally invasive hysterectomy with minimally invasive GYN surgeon at Johns Hopkins Hospital
- Patients must be English speaking.
Who cannot join
- Pregnancy
- allergy, contraindication, or intolerance to bupivacaine, opioids, Tylenol, or NSAID drugs
- pre-operative daily opioid consumption
- peri-operative transverse abdominis plane block
- recent history of drug or alcohol abuse (in last year)
- severe cardiovascular, hepatic or renal disease.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Howard County General Hospital
Columbia, Maryland, 21044
About this study
Official title: The Effect of Intra-operative Uterosacral Bupivacaine Injection on Post-operative Pain in Patients Undergoing Minimally Invasive Hysterectomy
This is proof of concept, phase I randomized controlled trial studying a short acting non-opioid anesthetic, bupivacaine to improve post-operative pain in gynecologic surgery patients. Patients who are undergoing minimally invasive (laparoscopic or robotic) hysterectomy will be randomized to receive no uterosacral injection, normal saline uterosacral injection, or 0.25% bupivacaine uterosacral injection just prior to colpotomy (incision around the cervix and removal of uterus) during minimally invasive hysterectomy.
- Conditions
- Pain, Postoperative, Opioid Use
- Being tested
- Bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Bupivicaine injection into uterosacral ligaments prior to colpotomy
| Study group | Role | What they receive |
|---|---|---|
| No injection | Placebo comparator | No injection will be performed Receives: Drug: Bupivacaine |
| Normal Saline Injection | Sham comparator | Normal saline will be injected into the uterosacral ligaments prior to colpotomy Receives: Drug: Bupivacaine |
| Bupivacaine Injection | Active comparator | Bupivacaine will be injected into the uterosacral ligaments prior to colpotomy Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in post-operative opioid usage with the use of uterosacral ligament bupivacaine injection
Total morphine equivalents of opioids in the first 7 days after surgery will be assessed to look for a statistically significant difference
Measured: 7 days post-op
Secondary outcomes (2)
Difference in Visual analog scores (VAS) scores following uterosacral ligament bupivicaine injection
Patient will report VAS scores daily until post-op day 7 on a scale of 1-10 with higher scores indicating higher pain severity. The investigators will be looking for a statistically significant difference between the treatment and placebo vs. sham group.
Measured: 7 days post-op
Time to first bowel movement following uterosacral ligament bupivicaine injection
Patients will record when they resume normal bowel function on a pill diary post-operatively
Measured: 7 days post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start15 Mar 2021
- Primary completion15 Oct 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Wang, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157075
- Sponsor's protocol ID
- IRB00221267
- Status last verified
- Mar 2022
- First submitted
- 6 Nov 2019
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frost AS, Kohn JR, Le Neveu M, Brah T, Okonkwo O, Borahay MA, Wu H, Simpson K, Patzkowsky KE, Wang KC. Laparoscopic administration of bupivacaine at the uterosacral ligaments during benign laparoscopic and robotic hysterectomy: a randomized controlled trial. Am J Obstet Gynecol. 2023 Nov;229(5):526.e1-526.e14. doi: 10.1016/j.ajog.2023.07.047. Epub 2023 Jul 31.
PubMed 37531986
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intra-operative Uterosacral Bupivacaine Injection on Post-operative Pain in Patients Undergoing Minimally Invasive Hysterectomy
- ClinicalTrials.gov ID
- NCT04157075
- Acronym / sponsor ID
- IRB00221267
- Conditions
- Pain, Postoperative, Opioid Use
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 8 Nov 2019 (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.
This is proof of concept, phase I randomized controlled trial studying a short acting non-opioid anesthetic, bupivacaine to improve post-operative pain in gynecologic surgery patients. Patients who are undergoing minimally invasive (laparoscopic or robotic) hysterectomy will be randomized to receive no uterosacral injection, normal saline uterosacral injection, or 0.25% bupivacaine uterosacral injection just prior to colpotomy (incision around the cervix and removal of uterus) during minimally invasive hysterectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No injection | Placebo comparator | Drug: BupivacaineNo injection will be performed |
| Normal Saline Injection | Sham comparator | Drug: BupivacaineNormal saline will be injected into the uterosacral ligaments prior to colpotomy |
| Bupivacaine Injection | Active comparator | Drug: BupivacaineBupivacaine will be injected into the uterosacral ligaments prior to colpotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women over the age of 18 years old
- undergoing benign minimally invasive hysterectomy with minimally invasive GYN surgeon at Johns Hopkins Hospital
- Patients must be English speaking.
Key exclusion criteria (6 listed)
- Pregnancy
- allergy, contraindication, or intolerance to bupivacaine, opioids, Tylenol, or NSAID drugs
- pre-operative daily opioid consumption
- peri-operative transverse abdominis plane block
- recent history of drug or alcohol abuse (in last year)
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 |
|---|---|---|
| BupivacaineBupivicaine injection into uterosacral ligaments prior to colpotomy | Drug | Bupivacaine Injection, No injection, Normal Saline Injection |
Primary outcome
Difference in post-operative opioid usage with the use of uterosacral ligament bupivacaine injection
Time frame: 7 days post-op
Total morphine equivalents of opioids in the first 7 days after surgery will be assessed to look for a statistically significant difference
2 secondary outcomes
Difference in Visual analog scores (VAS) scores following uterosacral ligament bupivicaine injection
Time frame: 7 days post-op
Time to first bowel movement following uterosacral ligament bupivicaine injection
Time frame: 7 days post-op
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 9 Nov 2022.
- Derived from this study: PubMed 37531986Frost AS, Kohn JR, Le Neveu M, Brah T, Okonkwo O, Borahay MA, Wu H, Simpson K, Patzkowsky KE, Wang KC. Laparoscopic administration of bupivacaine at the uterosacral ligaments during benign laparoscopic and robotic hysterectomy: a randomized controlled trial. Am J Obstet Gynecol. 2023 Nov;229(5):526.e1-526.e14. doi: 10.1016/j.ajog.2023.07.047. Epub 2023 Jul 31.
- 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.
Karen Wang principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Bupivacaine in people with Pain, Postoperative and Opioid Use, run by Johns Hopkins University at 2 sites 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 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 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 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?
Difference in post-operative opioid usage with the use of uterosacral ligament bupivacaine injection (time frame: 7 days post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04157075, which also lists 1 linked publication.
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 9 Nov 2022.