Pain After SurgeryPAIN-TVTNCT07429019
Intraoperative Bupivacaine Injection to Reduce Acute and Chronic Pain After TVT/TVT-O Surgery. Randomized Double-Blind Trial
A study testing Bupivacain (Postoperative) in people with Pain After Surgery and PSP, run by Hadassah Medical Organization.
Trial summary
This randomized, double-blind controlled trial will evaluate whether intraoperative injection of bupivacaine at the sling insertion site reduces postoperative pelvic and thigh pain in women undergoing TVT or TVT-O surgery for stress urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain After Surgery, PSP, Chronic Pain Syndrome
- What is being tested?
- Bupivacain (Postoperative)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Oct 2027
- Phase
- Interventional
- 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
- Women aged 18 years or older
- Scheduled to undergo vaginal surgery including TVT or TVT-O procedure for stress urinary incontinence
- Able and willing to provide written informed consent
- Willing to complete postoperative follow-up assessments for at least 6 months
Who cannot join
- Planned concomitant abdominal, laparoscopic, or robotic surgery
- Pre-existing chronic pelvic pain
- Diagnosis of fibromyalgia
- Diagnosis of endometriosis
- Inability to complete follow-up assessments
- Inability to provide informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Reduction of Post-surgery Pelvic Pain by Bupivacaine Injection During TVT/ TVT-O Procedure
This randomized, double-blind controlled trial will evaluate whether intraoperative injection of bupivacaine at the sling insertion site reduces postoperative pelvic and thigh pain in women undergoing TVT or TVT-O surgery for stress urinary incontinence. Women aged 18 years and older scheduled for vaginal surgery including a mid-urethral sling procedure will be randomly assigned to receive either 0.5% bupivacaine or saline injection at the surgical site at the end of the procedure.
Postoperative pain will be assessed using the Numerical Rating Scale (NRS) within 24 hours after surgery, at one month, and at least six months postoperatively. The study will also evaluate opioid consumption and examine the relationship between early postoperative pain and the development of chronic postsurgical pain. The results may help determine whether local anesthetic injection during sling surgery can improve short- and long-term pain outcomes.
- Being tested
- Bupivacain (Postoperative), Placebo
- Keywords
- TVT, TVTO, Mid Urethral Sling, pain, chronic pain syndrom
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacain (Postoperative)Drug
A 5 mL injection of 0.5% bupivacaine will be administered into the trans-obturator/levator ani sling insertion site at the end of the TVT or TVT-O procedure, prior to wound closure.
PlaceboOther
Participants will receive a 5 mL injection of sterile 0.9% normal saline into the trans-obturator/levator ani sling insertion site at the end of the TVT or TVT-O procedure, prior to wound closure.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine surgical site injection | Active comparator | Participants undergoing TVT or TVT-O surgery for stress urinary incontinence will receive a 5 mL injection of 0.5% bupivacaine into the trans-obturator/levator ani muscle sling insertion site at the end of the procedure. All participants will receive standard postoperative care, including systemic analgesics as needed. Receives: Drug: Bupivacain (Postoperative) |
| Placebo: Saline Injection | Placebo comparator | Participants undergoing TVT or TVT-O surgery for stress urinary incontinence will receive a 5 mL injection of normal saline into the same surgical site at the end of the procedure. All participants will receive standard postoperative care, including systemic analgesics as needed. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity assessed using the Numerical Rating Scale (NRS, 0-10 scale)
Pain intensity will be evaluated using the 11-point Numerical Rating Scale (NRS), where 0 represents no pain and 10 represents the worst pain imaginable. Assessments will be performed during hospital recovery (within 12-24 hours after surgery), at 1 month, and at 6 months postoperatively to evaluate both acute and chronic postsurgical pain.
Measured: Within 24 hours after surgery, at 1 month, and at 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain After SurgeryStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429019
- Sponsor's protocol ID
- HMO-0550-25
- Acronym
- PAIN-TVT
- Status last verified
- Jun 2026
- First submitted
- 15 Feb 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Post-surgery Pelvic Pain by Bupivacaine Injection During TVT/ TVT-O Procedure
- ClinicalTrials.gov ID
- NCT07429019
- Acronym / sponsor ID
- PAIN-TVT / HMO-0550-25
- Keywords
- TVT, TVTO, Mid Urethral Sling, pain, chronic pain syndrom
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 24 Feb 2026 (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 randomized, double-blind controlled trial will evaluate whether intraoperative injection of bupivacaine at the sling insertion site reduces postoperative pelvic and thigh pain in women undergoing TVT or TVT-O surgery for stress urinary incontinence. Women aged 18 years and older scheduled for vaginal surgery including a mid-urethral sling procedure will be randomly assigned to receive either 0.5% bupivacaine or saline injection at the surgical site at the end of the procedure.
Postoperative pain will be assessed using the Numerical Rating Scale (NRS) within 24 hours after surgery, at one month, and at least six months postoperatively. The study will also evaluate opioid consumption and examine the relationship between early postoperative pain and the development of chronic postsurgical pain. The results may help determine whether local anesthetic injection during sling surgery can improve short- and long-term pain outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine surgical site injection | Active comparator | Drug: Bupivacain (Postoperative)Participants undergoing TVT or TVT-O surgery for stress urinary incontinence will receive a 5 mL injection of 0.5% bupivacaine into the trans-obturator/levator ani muscle sling insertion site at the end of the procedure. All participants will receive standard postoperative care, including systemic analgesics as needed. |
| Placebo: Saline Injection | Placebo comparator | Other: PlaceboParticipants undergoing TVT or TVT-O surgery for stress urinary incontinence will receive a 5 mL injection of normal saline into the same surgical site at the end of the procedure. All participants will receive standard postoperative care, including systemic analgesics as needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women aged 18 years or older
- Scheduled to undergo vaginal surgery including TVT or TVT-O procedure for stress urinary incontinence
- Able and willing to provide written informed consent
- Willing to complete postoperative follow-up assessments for at least 6 months
Key exclusion criteria (6 listed)
- Planned concomitant abdominal, laparoscopic, or robotic surgery
- Pre-existing chronic pelvic pain
- Diagnosis of fibromyalgia
- Diagnosis of endometriosis
- Inability to complete follow-up assessments
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 |
|---|---|---|
| Bupivacain (Postoperative)A 5 mL injection of 0.5% bupivacaine will be administered into the trans-obturator/levator ani sling insertion site at the end of the TVT or TVT-O procedure, prior to wound closure. | Drug | Bupivacaine surgical site injection |
| PlaceboParticipants will receive a 5 mL injection of sterile 0.9% normal saline into the trans-obturator/levator ani sling insertion site at the end of the TVT or TVT-O procedure, prior to wound closure. | Other | Placebo: Saline Injection |
Primary outcome
Postoperative pain intensity assessed using the Numerical Rating Scale (NRS, 0-10 scale)
Time frame: Within 24 hours after surgery, at 1 month, and at 6 months postoperatively
Pain intensity will be evaluated using the 11-point Numerical Rating Scale (NRS), where 0 represents no pain and 10 represents the worst pain imaginable. Assessments will be performed during hospital recovery (within 12-24 hours after surgery), at 1 month, and at 6 months postoperatively to evaluate both acute and chronic postsurgical pain.
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 23 Jun 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacain (Postoperative) in people with Pain After Surgery and PSP, run by Hadassah Medical Organization.
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 4 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: opening soon, as of the sponsor's last update on 23 Jun 2026. 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. 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.
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 Nir Cohen, MD-MPh (00972506716211, nirco@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity assessed using the Numerical Rating Scale (NRS, 0-10 scale) (time frame: Within 24 hours after surgery, at 1 month, and at 6 months postoperatively). 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 23 Jun 2026.