Opioid UsePhase 4NCT07213635
Paracervical Injection and Opioid Use After Vaginal Hysterectomy for Prolapse
A Phase 4 study testing Bupivacaine-epinephrine and Normal saline in people with Opioid Use and Surgical Recovery, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The goal of the study to see if giving a numbing medicine around the cervix (called a paracervical block) during vaginal hysterectomy with prolapse repair helps people feel less pain and need fewer strong pain medicines afterward. 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
- Opioid Use, Surgical Recovery, Vaginal Hysterectomy
- What is being tested?
- Bupivacaine-epinephrine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2025to 24 Sep 2026
- 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
- Individuals undergoing vaginal hysterectomy with concomitant prolapse repair procedure
Who cannot join
- Non-English speaking
- Weight less than 50 kg
- Allergy to bupivacaine
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX
Raleigh, North Carolina, 27607
About this study
Official title: Effect of Paracervical Block on Postoperative Opioid Use in Vaginal Hysterectomy for Prolapse: a Randomized, Placebo-Controlled Trial
The goal of the study to see if giving a numbing medicine around the cervix (called a paracervical block) during vaginal hysterectomy with prolapse repair helps people feel less pain and need fewer strong pain medicines afterward.
The main question it aims to answer is:
Read more
- Does receiving a paracervical block at the time of vaginal hysterectomy with prolapse repair reduce postoperative opioid use?
Researchers will compare opioid use in participants who receive the an injected numbing medicine (bupivacaine with lidocaine) to those that receive a saltwater liquid placebo.
Participants will:
- Receive either an injection of the numbing medicine (bupivacaine with lidocaine) or saltwater liquid placebo after they are asleep but before any other parts of the surgery are done
- Record and report pain medications used for 7 days after surgery
- Report pain scores before discharge from the post anesthesia recovery area on day of surgery as well as 1 and 7 days after surgery
- Complete a surgical recovery questionnaire during 6 week postoperative visit
- Complete a one page multiple-choice test on pelvic organ prolapse
Read the detailed description
Secondary outcomes are to:
- Compare postoperative pain scores in patients undergoing vaginal hysterectomy for prolapse repair who receive an intraoperative paracervical block compared to placebo
- Compare surgical recovery times in patients undergoing vaginal hysterectomy for prolapse repair who receive an intraoperative paracervical block compared to placebo.
- Examine incidence of adverse events in patients undergoing vaginal hysterectomy for prolapse repair who receive intraoperative paracervical block compared to placebo
- Being tested
- Bupivacaine-epinephrine, Normal saline
- Keywords
- paracervical block, vaginal hysterectomy, prolapse repair, postoperative opioid use, postoperative pain scores, postoperative recovery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine-epinephrineDrug
Participants randomized to this experimental arm will receive a paracervical block with 10 mL 0.5% bupivacaine with epinephrine before their vaginal hysterectomy and prolapse repair
Normal salineDrug
Also called Placebo
Participants randomized to this experimental arm will receive a placebo paracervical injection with 10 mL 0.5% normal saline before their vaginal hysterectomy and prolapse repair
| Study group | Role | What they receive |
|---|---|---|
| Paracervical block | Experimental | Participants randomized to this experimental arm will receive a paracervical block with 0.5% bupivacaine with epinephrine at the time of vaginal hysterectomy with prolapse repair Receives: Drug: Bupivacaine-epinephrine |
| Placebo | Placebo comparator | Participants randomized to this experimental arm will receive a placebo paracervical injection with normal saline at the time of vaginal hysterectomy with prolapse repair Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid use
Mean postoperative opioid use converted to morphine milligram equivalents
Measured: Assessed verbally during a 5 minute phone call on day 1 and 7 following surgery
Secondary outcomes (4)
Pain score
Mean numeric visual analog pain score from 0-10 where 0 is "no pain" and 10 is "worst pain you can imagine"
Measured: Assessed verbally prior to discharge from post anesthesia recovery area, and during 5 minute phone call on day 1 and 7 following surgery
Global Surgical Recovery score
Mean Global Surgical Recovery score (from 0-100%) where 0% is not recovered at all and 100% is fully recovered.
Measured: Assessed verbally during 5 minute phone call on day 1 and 7 following surgery.
Postdischarge Surgical Recovery
Mean Postdischarge Surgical Recovery score (from 0-100) where higher scores denote better recovery.
Measured: Assessed during completion of 5 minute survey on week 6 postoperative visit.
Adverse events
Number of hospital admission (including on day of surgery) and emergency department presentations as well as additional calls or urgent clinic visits
Measured: From day of surgery until week 6 postoperative visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start20 Oct 2025
- Primary completion12 Aug 2026
- Study completion24 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertie Geng, MD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213635
- Sponsor's protocol ID
- 25-0619
- Status last verified
- Sep 2026
- First submitted
- 2 Oct 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Paracervical Block on Postoperative Opioid Use in Vaginal Hysterectomy for Prolapse: a Randomized, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07213635
- Acronym / sponsor ID
- 25-0619
- Keywords
- paracervical block, vaginal hysterectomy, prolapse repair, postoperative opioid use, postoperative pain scores, postoperative recovery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 12 Aug 2026 (actual)
- Study completion
- 24 Sep 2026 (actual)
- First posted
- 9 Oct 2025 (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 goal of the study to see if giving a numbing medicine around the cervix (called a paracervical block) during vaginal hysterectomy with prolapse repair helps people feel less pain and need fewer strong pain medicines afterward.
The main question it aims to answer is:
- Does receiving a paracervical block at the time of vaginal hysterectomy with prolapse repair reduce postoperative opioid use?
Researchers will compare opioid use in participants who receive the an injected numbing medicine (bupivacaine with lidocaine) to those that receive a saltwater liquid placebo.
Participants will:
- Receive either an injection of the numbing medicine (bupivacaine with lidocaine) or saltwater liquid placebo after they are asleep but before any other parts of the surgery are done
- Record and report pain medications used for 7 days after surgery
- Report pain scores before discharge from the post anesthesia recovery area on day of surgery as well as 1 and 7 days after surgery
- Complete a surgical recovery questionnaire during 6 week postoperative visit
- Complete a one page multiple-choice test on pelvic organ prolapse
Detailed description
Secondary outcomes are to:
- Compare postoperative pain scores in patients undergoing vaginal hysterectomy for prolapse repair who receive an intraoperative paracervical block compared to placebo
- Compare surgical recovery times in patients undergoing vaginal hysterectomy for prolapse repair who receive an intraoperative paracervical block compared to placebo.
- Examine incidence of adverse events in patients undergoing vaginal hysterectomy for prolapse repair who receive intraoperative paracervical block compared to placebo
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracervical block | Experimental | Drug: Bupivacaine-epinephrineParticipants randomized to this experimental arm will receive a paracervical block with 0.5% bupivacaine with epinephrine at the time of vaginal hysterectomy with prolapse repair |
| Placebo | Placebo comparator | Drug: Normal salineParticipants randomized to this experimental arm will receive a placebo paracervical injection with normal saline at the time of vaginal hysterectomy with prolapse repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals undergoing vaginal hysterectomy with concomitant prolapse repair procedure
Key exclusion criteria (4 listed)
- Non-English speaking
- Weight less than 50 kg
- Allergy to bupivacaine
- Pregnant
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 |
|---|---|---|
| Bupivacaine-epinephrineParticipants randomized to this experimental arm will receive a paracervical block with 10 mL 0.5% bupivacaine with epinephrine before their vaginal hysterectomy and prolapse repair | Drug | Paracervical block |
| Normal salineAlso: PlaceboParticipants randomized to this experimental arm will receive a placebo paracervical injection with 10 mL 0.5% normal saline before their vaginal hysterectomy and prolapse repair | Drug | Placebo |
Primary outcome
Postoperative opioid use
Time frame: Assessed verbally during a 5 minute phone call on day 1 and 7 following surgery
Mean postoperative opioid use converted to morphine milligram equivalents
4 secondary outcomes
Pain score
Time frame: Assessed verbally prior to discharge from post anesthesia recovery area, and during 5 minute phone call on day 1 and 7 following surgery
Global Surgical Recovery score
Time frame: Assessed verbally during 5 minute phone call on day 1 and 7 following surgery.
Postdischarge Surgical Recovery
Time frame: Assessed during completion of 5 minute survey on week 6 postoperative visit.
Adverse events
Time frame: From day of surgery until week 6 postoperative visit
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 2 Oct 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Bertie Geng, MD principal investigator
University of North Carolina
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 Bupivacaine-epinephrine and Normal saline in people with Opioid Use and Surgical Recovery, run by University of North Carolina, Chapel Hill 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 1 inclusion and 4 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 2 Oct 2026. 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?
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?
Postoperative opioid use (time frame: Assessed verbally during a 5 minute phone call on day 1 and 7 following surgery). 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 2 Oct 2026.