Pelvic Organ Prolapse (POP)vNOTES-PBNCT07440576
Effect of Paracervical Block on Postoperative Pain After vNOTES Uterosacral Ligament Suspension
A study testing Bupivacaine and Normal Saline in people with Pelvic Organ Prolapse (POP) and Postoperative Pain, run by Erkan Gol at 1 site in Turkey (Türkiye).
Trial summary
This study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of paracervical block on early postoperative pain after vaginal natural orifice transluminal endoscopic surgery (vNOTES) uterosacral ligament suspension. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse (POP), Postoperative Pain
- What is being tested?
- Bupivacaine and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Mar 2026to Feb 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
- Female patients aged 18 years or older
- Symptomatic pelvic organ prolapse requiring uterosacral ligament suspension (USLS)
- Planned hysterectomy (vaginal hysterectomy or vNOTES hysterectomy) with concomitant BS or BSO, followed by vNOTES uterosacral ligament suspension
- ASA physical status I-III
- Ability to provide written informed consent
Who cannot join
- Known allergy or hypersensitivity to bupivacaine or local anesthetic agents
- Chronic opioid use or chronic pain disorders
- Previous pelvic radiation therapy
- Severe hepatic or renal impairment
- Coagulopathy or anticoagulant therapy contraindicating injection
- Active pelvic infection
- Pregnancy
- Inability to understand the pain scoring system
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bakirkoy Dr. Sadi Konuk Training and Research Hospital
Istanbul, Istanbul, 34147
Erkan Göl, MD, +905398517917, drerkangol@gmail.com
Keziban Doğan, Professor, +905356336207, drkzbn70@gmail.com
About this study
Official title: A Prospective Randomized Double-Blind Placebo-Controlled Trial Evaluating the Effect of Paracervical Block on Postoperative Pain After vNOTES Uterosacral Ligament Suspension
This study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of paracervical block on early postoperative pain after vaginal natural orifice transluminal endoscopic surgery (vNOTES) uterosacral ligament suspension.
Eligible patients undergoing vNOTES uterosacral ligament suspension for benign gynecologic indications will be randomly assigned in a 1:1 ratio to receive either 10 mL of 0.5% bupivacaine or 10 mL of normal saline as a paracervical injection during surgery.
Read more
The primary outcome is postoperative pain assessed using the Visual Analog Scale (VAS) at 6 hours after surgery. Secondary outcomes include pain scores at multiple time points within 24 hours, total analgesic consumption, length of hospital stay, and patient satisfaction.
The study aims to determine whether paracervical block provides clinically meaningful pain reduction in the early postoperative period following vNOTES procedures.
Read the detailed description
Postoperative pain management remains an important component of enhanced recovery protocols in minimally invasive gynecologic surgery. Although vNOTES uterosacral ligament suspension is associated with reduced abdominal wall trauma, patients may still experience significant early postoperative pelvic pain. Paracervical block with local anesthetic agents has been proposed as a potential strategy to reduce early postoperative pain; however, high-quality randomized evidence in the context of vNOTES procedures is limited.
This single-center, prospective, randomized, double-blind, placebo-controlled trial will enroll 58 patients undergoing vNOTES uterosacral ligament suspension. Participants will be randomized using computer-generated permuted block randomization with allocation concealment ensured through sequentially numbered, opaque, sealed envelopes. During surgery, a blinded syringe containing either 0.5% bupivacaine or normal saline will be prepared by independent personnel and administered as a paracervical injection.
Postoperative pain will be evaluated using the Visual Analog Scale (VAS) at predefined time points (0, 1, 2, 4, 6, 12, and 24 hours). The primary endpoint is VAS score at 6 hours postoperatively. Secondary endpoints include total analgesic consumption within 24 hours, patient satisfaction, and perioperative recovery parameters. Statistical analyses will be conducted according to the intention-to-treat principle.
- Conditions
- Pelvic Organ Prolapse (POP), Postoperative Pain
- Being tested
- Bupivacaine, Normal Saline
- Keywords
- vnotes, uterosacral ligament suspension, paracervical block, bupivacaine, minimally invasive surgery, enhanced recovery
- Medical subject headings
- Pelvic Organ Prolapse, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
A total of 10 mL of 0.5% bupivacaine will be administered as a paraservical injection during vNOTES uterosacral ligament suspension. The solution will be prepared in identical syringes by independent personnel to maintain blinding.
Normal SalineDrug
Also called 0.9% Sodium Chloride
A total of 10 mL of 0.9% normal saline will be administered as a paraservical injection during vNOTES uterosacral ligament suspension. The solution will be prepared in identical syringes to ensure blinding.
| Study group | Role | What they receive |
|---|---|---|
| Paracervical Block (Bupivacaine) | Experimental | Participants will receive 10 mL of 0.5% bupivacaine administered as a paraservical injection during vNOTES uterosacral ligament suspension. Receives: Drug: Bupivacaine |
| Placebo (Normal Saline) | Placebo comparator | Participants will receive 10 mL of 0.9% normal saline administered as a paraservical injection during vNOTES uterosacral ligament suspension. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score at 6 Hours
Postoperative pain intensity assessed using a 10-cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores represent greater pain intensity.
Measured: 6 hours after completion of surgery (assessed once at postoperative hour 6)
Secondary outcomes (4)
Postoperative Pain Scores Within 24 Hours
Postoperative pain intensity assessed using a 10-cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores will be recorded at postoperative hours 0 (upon arrival in recovery room), 1, 2, 4, 12, and 24.
Measured: From completion of surgery through postoperative hour 24 (assessed at 0, 1, 2, 4, 12, and 24 hours)
Total Analgesic Consumption
Total cumulative dose of rescue analgesic medication administered postoperatively, recorded in milligrams (mg) and converted to morphine-equivalent dose when applicable. Higher values indicate greater analgesic requirement.
Measured: From completion of surgery through postoperative hour 24 (cumulative dose assessed up to 24 hours)
Patient Satisfaction
Patient-reported satisfaction with postoperative pain control assessed using a 10-point Numeric Rating Scale (0 = not satisfied at all; 10 = completely satisfied). Higher scores represent greater satisfaction.
Measured: 24 hours after completion of surgery (assessed once at postoperative hour 24)
Length of Hospital Stay
Duration of hospitalization measured in days from the date of surgery until discharge.
Measured: From the date of surgery until hospital discharge, assessed up to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start9 Mar 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ Prolapse (POP)Studies 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 will be randomized in a 1:1 ratio to receive either paracervical block with 0.5% bupivacaine or a placebo (normal saline) during vNOTES uterosacral ligament suspension.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erkan Gol
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Erkan Gol, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- Erkan Göl, MD, Principal investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440576
- Sponsor's protocol ID
- 2026-04-05
- Acronym
- vNOTES-PB
- Status last verified
- Mar 2026
- First submitted
- 12 Feb 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Double-Blind Placebo-Controlled Trial Evaluating the Effect of Paracervical Block on Postoperative Pain After vNOTES Uterosacral Ligament Suspension
- ClinicalTrials.gov ID
- NCT07440576
- Acronym / sponsor ID
- vNOTES-PB / 2026-04-05
- Conditions
- Pelvic Organ Prolapse (POP), Postoperative Pain
- Keywords
- vnotes, uterosacral ligament suspension, paracervical block, bupivacaine, minimally invasive surgery, enhanced recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Erkan GolOther government
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 27 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 study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of paracervical block on early postoperative pain after vaginal natural orifice transluminal endoscopic surgery (vNOTES) uterosacral ligament suspension.
Eligible patients undergoing vNOTES uterosacral ligament suspension for benign gynecologic indications will be randomly assigned in a 1:1 ratio to receive either 10 mL of 0.5% bupivacaine or 10 mL of normal saline as a paracervical injection during surgery.
The primary outcome is postoperative pain assessed using the Visual Analog Scale (VAS) at 6 hours after surgery. Secondary outcomes include pain scores at multiple time points within 24 hours, total analgesic consumption, length of hospital stay, and patient satisfaction.
The study aims to determine whether paracervical block provides clinically meaningful pain reduction in the early postoperative period following vNOTES procedures.
Detailed description
Postoperative pain management remains an important component of enhanced recovery protocols in minimally invasive gynecologic surgery. Although vNOTES uterosacral ligament suspension is associated with reduced abdominal wall trauma, patients may still experience significant early postoperative pelvic pain. Paracervical block with local anesthetic agents has been proposed as a potential strategy to reduce early postoperative pain; however, high-quality randomized evidence in the context of vNOTES procedures is limited.
This single-center, prospective, randomized, double-blind, placebo-controlled trial will enroll 58 patients undergoing vNOTES uterosacral ligament suspension. Participants will be randomized using computer-generated permuted block randomization with allocation concealment ensured through sequentially numbered, opaque, sealed envelopes. During surgery, a blinded syringe containing either 0.5% bupivacaine or normal saline will be prepared by independent personnel and administered as a paracervical injection.
Postoperative pain will be evaluated using the Visual Analog Scale (VAS) at predefined time points (0, 1, 2, 4, 6, 12, and 24 hours). The primary endpoint is VAS score at 6 hours postoperatively. Secondary endpoints include total analgesic consumption within 24 hours, patient satisfaction, and perioperative recovery parameters. Statistical analyses will be conducted according to the intention-to-treat principle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive either paracervical block with 0.5% bupivacaine or a placebo (normal saline) during vNOTES uterosacral ligament suspension.
| Arm | Type | Receives |
|---|---|---|
| Paracervical Block (Bupivacaine) | Experimental | Drug: BupivacaineParticipants will receive 10 mL of 0.5% bupivacaine administered as a paraservical injection during vNOTES uterosacral ligament suspension. |
| Placebo (Normal Saline) | Placebo comparator | Drug: Normal SalineParticipants will receive 10 mL of 0.9% normal saline administered as a paraservical injection during vNOTES uterosacral ligament suspension. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female patients aged 18 years or older
- Symptomatic pelvic organ prolapse requiring uterosacral ligament suspension (USLS)
- Planned hysterectomy (vaginal hysterectomy or vNOTES hysterectomy) with concomitant BS or BSO, followed by vNOTES uterosacral ligament suspension
- ASA physical status I-III
- Ability to provide written informed consent
Key exclusion criteria (8 listed)
- Known allergy or hypersensitivity to bupivacaine or local anesthetic agents
- Chronic opioid use or chronic pain disorders
- Previous pelvic radiation therapy
- Severe hepatic or renal impairment
- Coagulopathy or anticoagulant therapy contraindicating injection
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 |
|---|---|---|
| BupivacaineA total of 10 mL of 0.5% bupivacaine will be administered as a paraservical injection during vNOTES uterosacral ligament suspension. The solution will be prepared in identical syringes by independent personnel to maintain blinding. | Drug | Paracervical Block (Bupivacaine) |
| Normal SalineAlso: 0.9% Sodium ChlorideA total of 10 mL of 0.9% normal saline will be administered as a paraservical injection during vNOTES uterosacral ligament suspension. The solution will be prepared in identical syringes to ensure blinding. | Drug | Placebo (Normal Saline) |
Primary outcome
Postoperative Pain Score at 6 Hours
Time frame: 6 hours after completion of surgery (assessed once at postoperative hour 6)
Postoperative pain intensity assessed using a 10-cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores represent greater pain intensity.
4 secondary outcomes
Postoperative Pain Scores Within 24 Hours
Time frame: From completion of surgery through postoperative hour 24 (assessed at 0, 1, 2, 4, 12, and 24 hours)
Total Analgesic Consumption
Time frame: From completion of surgery through postoperative hour 24 (cumulative dose assessed up to 24 hours)
Patient Satisfaction
Time frame: 24 hours after completion of surgery (assessed once at postoperative hour 24)
Length of Hospital Stay
Time frame: From the date of surgery until hospital discharge, assessed up to 30 days postoperatively
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 11 Mar 2026.
- 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.
Erkan Göl, MD principal investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
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 and Normal Saline in people with Pelvic Organ Prolapse (POP) and Postoperative Pain, run by Erkan Gol 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 5 inclusion and 8 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 11 Mar 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. 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 Erkan Göl, MD (+905398517917, drerkangol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Score at 6 Hours (time frame: 6 hours after completion of surgery (assessed once at postoperative hour 6)). 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 11 Mar 2026.