HysterectomyPhase 4NCT06719180
Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use
A Phase 4 study testing Bupivacain in people with Hysterectomy and Post Operative Analgesia, run by MediSys Health Network at 1 site in United States.
Trial summary
The purpose of this study is to determine whether an injection of a local anesthetic (Bupivacaine with epinephrine) in the vaginal cuff prior to closure would result in less immediate postoperative pain medication and increase patient comfort/satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hysterectomy, Post Operative Analgesia
- What is being tested?
- Bupivacain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 31 Oct 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years and older requiring total laparoscopic hysterectomy with or without bilateral salpingo-oophorectomy for benign conditions
- Presence of malignancy
Who cannot join
- Conversion to laparotomy
- Previous multiple abdominal and/or pelvic surgeries
- Significant medical comorbidities or cardiac history
- Poor initial Aldrete score4 (<10)
- Significant pre-op pain medication use
- Contraindication to any medication that would be used in the study (Bupivacaine, epinephrine, tramadol or oxycodone)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Flushing Hospital Medical Center
Flushing, New York, 11355
Hosam Hanna, MD, (718) 670-5571, hhanna@jhmc.org
About this study
Official title: A Prospective Randomized Controlled Trial of Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use
The purpose of this study is to determine whether an injection of a local anesthetic (Bupivacaine with epinephrine) in the vaginal cuff prior to closure would result in less immediate postoperative pain medication and increase patient comfort/satisfaction.
- Conditions
- Hysterectomy, Post Operative Analgesia
- Being tested
- Bupivacain, Saline (NaCl 0,9 %) (placebo)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
Injection into the vaginal cuff will occur before vaginal cuff closure with stratafix suture. There will be four points of injection 1cm from the edges of the vaginal cuff with a sterilized needle to a depth of 3-4cm. 5cc of bupivacaine with epinephrine or 5cc of normal saline will be injected into each area
Saline (NaCl 0,9 %) (placebo)Other
A saline placebo
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Cuff Anesthesia | Experimental | Not described Receives: Drug: Bupivacain |
| Vaginal Cuff Saline | Placebo comparator | Not described Receives: Other: Saline (NaCl 0,9 %) (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Milligrams of Morphine Equivalent Used
Measured: From enrollment to end of treatment at 4 hours.
Secondary outcomes (2)
Counts of Non-Opioid Analgesics Used
Measured: From enrollment to end of treatment at 4 hours.
Patient Change in Pain Score (0-10)
Change in value of pain score, measured on a 0-10 scale.
Measured: From Baseline to end of treatment at 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Dec 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MediSys Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719180
- Sponsor's protocol ID
- 2172359
- Status last verified
- Jan 2025
- First submitted
- 22 Nov 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of Vaginal Cuff Anesthesia and Post-Operative Pain Medication Use
- ClinicalTrials.gov ID
- NCT06719180
- Acronym / sponsor ID
- 2172359
- Conditions
- Hysterectomy, Post Operative Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- MediSys Health NetworkUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 5 Dec 2024 (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 whether an injection of a local anesthetic (Bupivacaine with epinephrine) in the vaginal cuff prior to closure would result in less immediate postoperative pain medication and increase patient comfort/satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal Cuff Anesthesia | Experimental | Drug: Bupivacain |
| Vaginal Cuff Saline | Placebo comparator | Other: Saline (NaCl 0,9 %) (placebo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years and older requiring total laparoscopic hysterectomy with or without bilateral salpingo-oophorectomy for benign conditions
- Presence of malignancy
Key exclusion criteria (6 listed)
- Conversion to laparotomy
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 |
|---|---|---|
| BupivacainInjection into the vaginal cuff will occur before vaginal cuff closure with stratafix suture. There will be four points of injection 1cm from the edges of the vaginal cuff with a sterilized needle to a depth of 3-4cm. 5cc of bupivacaine with epinephrine or 5cc of normal saline will be injected into each area | Drug | Vaginal Cuff Anesthesia |
| Saline (NaCl 0,9 %) (placebo)A saline placebo | Other | Vaginal Cuff Saline |
Primary outcome
Milligrams of Morphine Equivalent Used
Time frame: From enrollment to end of treatment at 4 hours.
2 secondary outcomes
Counts of Non-Opioid Analgesics Used
Time frame: From enrollment to end of treatment at 4 hours.
Patient Change in Pain Score (0-10)
Time frame: From Baseline to end of treatment at 4 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacain in people with Hysterectomy and Post Operative Analgesia, run by MediSys Health Network 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 2 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: looking for participants now, as of the sponsor's last update on 7 Jan 2025. 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. 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?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hosam Hanna, MD ((718) 670-5571, hhanna@jhmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Milligrams of Morphine Equivalent Used (time frame: From enrollment to end of treatment at 4 hours.). 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 7 Jan 2025.