Postoperative Pain ManagementmarcaineNCT07426666
Vaginal Cuff Bupivacaine Injection for Postoperative Pain
A study testing Bupivacaine %0.25 (isobaric) in people with Postoperative Pain Management, run by Havva Betül Bacak at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study evaluates whether injecting bupivacaine into the vaginal cuff during vaginal hysterectomy reduces postoperative pain. Vaginal hysterectomy is commonly performed for benign gynecologic conditions. Read more about this study
- Who is it for?
- Ages 35 to 75 years, women only
- Conditions the study is for
- Postoperative Pain Management
- What is being tested?
- Bupivacaine %0.25 (isobaric)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Aug 2025to 24 Oct 2025
- 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 35 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 35 to 75 years
- Scheduled for elective vaginal hysterectomy for benign gynecologic indications (e.g., uterine fibroids, adenomyosis, abnormal uterine bleeding, pelvic organ prolapse)
- Able to provide written informed consent
Who cannot join
- Known or suspected gynecologic malignancy (endometrial, cervical, or uterine)
- Allergy or hypersensitivity to local anesthetics, especially bupivacaine
- Prior pelvic radiotherapy or major pelvic surgery resulting in altered anatomy
- Conditions preventing vaginal cuff injection (e.g., extensive scarring, active infection)
- Inability to reliably assess pain (e.g., impaired consciousness, dementia, severe psychiatric disorder)
- Refusal to sign informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBÜ Gaziosmanpaşa Training and Research Hospital
Istanbul, Outside of the US, 33400
About this study
Official title: The Effect of Vaginal Cuff Bupivacaine Injection on Postoperative Pain After Vaginal Hysterectomy
This randomized controlled study evaluates whether injecting bupivacaine into the vaginal cuff during vaginal hysterectomy reduces postoperative pain. Vaginal hysterectomy is commonly performed for benign gynecologic conditions. Although it is associated with less pain compared to abdominal surgery, postoperative discomfort may still affect recovery and patient satisfaction.
In this study, 48 women undergoing elective vaginal hysterectomy were randomly assigned to two groups. In the intervention group, 0.25% bupivacaine was injected bilaterally into the vaginal cuff after closure. In the control group, no local anesthetic injection was administered. All patients received the same standard postoperative pain management protocol.
Pain levels were measured using the Visual Analog Scale (VAS) at 1, 3, 6, 12, and 24 hours after surgery. Additional analgesic consumption and possible complications were also recorded. The study aims to determine whether vaginal cuff bupivacaine infiltration improves early postoperative pain control.
Read the detailed description
This prospective, single-center, randomized controlled trial was conducted to evaluate the effect of bilateral vaginal cuff infiltration with 0.25% bupivacaine on postoperative pain following vaginal hysterectomy performed for benign gynecologic indications.
Vaginal hysterectomy, although minimally invasive, may still be associated with significant postoperative discomfort. The uterus and surrounding structures receive innervation from the uterosacral plexus (Lee-Frankenhauser plexus), which plays a role in postoperative pain transmission. Local anesthetic infiltration targeting this anatomical region may reduce nociceptive signaling and improve early postoperative pain control.
A total of 48 women aged 35-75 years scheduled for elective vaginal hysterectomy were randomized using a sealed-envelope method into two parallel groups:
Intervention group (n=24): Bilateral infiltration of 10 mL 0.25% bupivacaine into the lateral aspects of the vaginal cuff following cuff closure.
Control group (n=24): Standard surgical procedure without local anesthetic infiltration.
All procedures were performed under general anesthesia. Postoperative analgesia was administered according to institutional standard protocol. Pain intensity was assessed using the Visual Analog Scale (VAS) at postoperative 1, 3, 6, 12, and 24 hours.
The primary outcome was postoperative pain intensity measured by VAS scores. Secondary outcomes included total analgesic consumption within the first 24 hours, intraoperative and postoperative complications, and length of hospital stay.
The study was completed after enrollment of 40 participants, and outcomes were analyzed to determine the efficacy and safety of vaginal cuff bupivacaine infiltration in reducing early postoperative pain following vaginal hysterectomy.
- Conditions
- Postoperative Pain Management
- Being tested
- Bupivacaine %0.25 (isobaric)
- Keywords
- Vaginal Hysterectomy, Bupivacaine, Analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine %0.25 (isobaric)Drug
0.25% bupivacaine (10 mL) was bilaterally infiltrated into the lateral aspects of the vaginal cuff following cuff closure during vaginal hysterectomy.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine Injection Group | Experimental | Participants in this group underwent standard vaginal hysterectomy. After vaginal cuff closure, bilateral infiltration of 10 mL 0.25% bupivacaine was administered to the lateral aspects of the vaginal cuff. All patients received the standard postoperative analgesia protocol. Receives: Drug: Bupivacaine %0.25 (isobaric) |
| Control Group | No intervention | Participants in this group underwent standard vaginal hysterectomy without local anesthetic infiltration of the vaginal cuff. All patients received the same standard postoperative analgesia protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)
Pain intensity was assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores were recorded at predefined postoperative time points to evaluate the effectiveness of vaginal cuff bupivacaine infiltration
Measured: 1, 3, 6, 12, and 24 hours postoperatively
Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)
Pain intensity was assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores were recorded at predefined postoperative time points to evaluate the effectiveness of vaginal cuff bupivacaine infiltration.
Measured: 1, 3, 6, 12, and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start5 Aug 2025
- Primary completion24 Oct 2025
- Study completion24 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain ManagementStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two parallel groups using a sealed-envelope method. The intervention group received bilateral vaginal cuff infiltration with 10 mL of 0.25% bupivacaine after cuff closure, while the control group underwent the same surgical procedure without local anesthetic infiltration. The study was conducted as a single-center, open-label randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Havva Betül Bacak
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Havva Betül Bacak, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426666
- Sponsor's protocol ID
- gopvahmarcaine
- Acronym
- marcaine
- Status last verified
- Feb 2026
- First submitted
- 15 Feb 2026
- Last updated
- 23 Feb 2026
- 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 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vaginal Cuff Bupivacaine Injection on Postoperative Pain After Vaginal Hysterectomy
- ClinicalTrials.gov ID
- NCT07426666
- Acronym / sponsor ID
- marcaine / gopvahmarcaine
- Conditions
- Postoperative Pain Management
- Keywords
- Vaginal Hysterectomy, Bupivacaine, Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Havva Betül BacakOther government
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 24 Oct 2025 (actual)
- Study completion
- 24 Oct 2025 (actual)
- First posted
- 23 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 controlled study evaluates whether injecting bupivacaine into the vaginal cuff during vaginal hysterectomy reduces postoperative pain. Vaginal hysterectomy is commonly performed for benign gynecologic conditions. Although it is associated with less pain compared to abdominal surgery, postoperative discomfort may still affect recovery and patient satisfaction.
In this study, 48 women undergoing elective vaginal hysterectomy were randomly assigned to two groups. In the intervention group, 0.25% bupivacaine was injected bilaterally into the vaginal cuff after closure. In the control group, no local anesthetic injection was administered. All patients received the same standard postoperative pain management protocol.
Pain levels were measured using the Visual Analog Scale (VAS) at 1, 3, 6, 12, and 24 hours after surgery. Additional analgesic consumption and possible complications were also recorded. The study aims to determine whether vaginal cuff bupivacaine infiltration improves early postoperative pain control.
Detailed description
This prospective, single-center, randomized controlled trial was conducted to evaluate the effect of bilateral vaginal cuff infiltration with 0.25% bupivacaine on postoperative pain following vaginal hysterectomy performed for benign gynecologic indications.
Vaginal hysterectomy, although minimally invasive, may still be associated with significant postoperative discomfort. The uterus and surrounding structures receive innervation from the uterosacral plexus (Lee-Frankenhauser plexus), which plays a role in postoperative pain transmission. Local anesthetic infiltration targeting this anatomical region may reduce nociceptive signaling and improve early postoperative pain control.
A total of 48 women aged 35-75 years scheduled for elective vaginal hysterectomy were randomized using a sealed-envelope method into two parallel groups:
Intervention group (n=24): Bilateral infiltration of 10 mL 0.25% bupivacaine into the lateral aspects of the vaginal cuff following cuff closure.
Control group (n=24): Standard surgical procedure without local anesthetic infiltration.
All procedures were performed under general anesthesia. Postoperative analgesia was administered according to institutional standard protocol. Pain intensity was assessed using the Visual Analog Scale (VAS) at postoperative 1, 3, 6, 12, and 24 hours.
The primary outcome was postoperative pain intensity measured by VAS scores. Secondary outcomes included total analgesic consumption within the first 24 hours, intraoperative and postoperative complications, and length of hospital stay.
The study was completed after enrollment of 40 participants, and outcomes were analyzed to determine the efficacy and safety of vaginal cuff bupivacaine infiltration in reducing early postoperative pain following vaginal hysterectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two parallel groups using a sealed-envelope method. The intervention group received bilateral vaginal cuff infiltration with 10 mL of 0.25% bupivacaine after cuff closure, while the control group underwent the same surgical procedure without local anesthetic infiltration. The study was conducted as a single-center, open-label randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine Injection Group | Experimental | Drug: Bupivacaine %0.25 (isobaric)Participants in this group underwent standard vaginal hysterectomy. After vaginal cuff closure, bilateral infiltration of 10 mL 0.25% bupivacaine was administered to the lateral aspects of the vaginal cuff. All patients received the standard postoperative analgesia protocol. |
| Control Group | No intervention | –Participants in this group underwent standard vaginal hysterectomy without local anesthetic infiltration of the vaginal cuff. All patients received the same standard postoperative analgesia protocol. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women aged 35 to 75 years
- Scheduled for elective vaginal hysterectomy for benign gynecologic indications (e.g., uterine fibroids, adenomyosis, abnormal uterine bleeding, pelvic organ prolapse)
- Able to provide written informed consent
Key exclusion criteria (6 listed)
- Known or suspected gynecologic malignancy (endometrial, cervical, or uterine)
- Allergy or hypersensitivity to local anesthetics, especially bupivacaine
- Prior pelvic radiotherapy or major pelvic surgery resulting in altered anatomy
- Conditions preventing vaginal cuff injection (e.g., extensive scarring, active infection)
- Inability to reliably assess pain (e.g., impaired consciousness, dementia, severe psychiatric disorder)
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 %0.25 (isobaric)0.25% bupivacaine (10 mL) was bilaterally infiltrated into the lateral aspects of the vaginal cuff following cuff closure during vaginal hysterectomy. | Drug | Bupivacaine Injection Group |
Primary outcome
Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)
Time frame: 1, 3, 6, 12, and 24 hours postoperatively
Pain intensity was assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores were recorded at predefined postoperative time points to evaluate the effectiveness of vaginal cuff bupivacaine infiltration
Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)
Time frame: 1, 3, 6, 12, and 24 hours postoperatively
Pain intensity was assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores were recorded at predefined postoperative time points to evaluate the effectiveness of vaginal cuff bupivacaine infiltration.
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 23 Feb 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine %0.25 (isobaric) in people with Postoperative Pain Management, run by Havva Betül Bacak at 1 site in Turkey (Türkiye).
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 23 Feb 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 Turkey (Türkiye). 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?
Postoperative Pain Intensity Measured by Visual Analog Scale (VAS) (time frame: 1, 3, 6, 12, and 24 hours postoperatively). The study lists 2 primary outcomes in all. 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 Feb 2026.