Fibroid UterusWINPLEXNCT06429163
Pre-incisional Wound INfiltration and Hypogastric PLEXus Block Using Ropivacaine in Laparoscopic Myomectomy
A study testing Troacar site infiltration and Superior hypogastric plexus block in people with Fibroid Uterus and Pain, Postoperative, run by Saint Petersburg State University, Russia at 1 site in Russia.
Trial summary
The purpose of this study is to assess an impact of laparoscopic superior hypogastric plexus (SHP) block combined with preemptive troacar site infiltration on postoperative pain intensity following laparoscopic myomectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibroid Uterus, Pain, Postoperative
- What is being tested?
- Troacar site infiltration and Superior hypogastric plexus block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 1 siteRussia
- Study dates
- 14 May 2024to 26 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
- Indication for laparoscopic myomectomy due to ≥6 cm fibroid(s) or multiple fibroids.
- Ability to provide informed consent.
Who cannot join
- FIGO type 7 subserosal pedunculated myoma.
- Conversion to laparotomy.
- Severe presacral adhesions preventing safe SHPB.
- Concomitant pelvic or abdominal surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Pre-incisional Wound Infiltration and Hypogastric Plexus Block Using Ropivacaine on Postoperative Pain Following Laparoscopic Myomectomy: A Single-Center, Prospective, Randomized, Placebo-Controlled, Double-Blind Study
The purpose of this study is to assess an impact of laparoscopic superior hypogastric plexus (SHP) block combined with preemptive troacar site infiltration on postoperative pain intensity following laparoscopic myomectomy.
Read the detailed description
Patients randomized into 3 groups with a target ratio of 1:1:1 were included in the study: group 1 received standard systemic analgesia combined with troacar site infiltration and laparoscopic SHP block; group 2 received troacar site infiltration without SHP block; control group (group 3) received standard systemic analgesia alone. The primary endpoint was presented by assessing pain intensity using the numeric rating scale (NRS) at 4 hours postoperatively. Secondary endpoints included NRS dynamics at 2, 6, 8, 12, and 24 hours postoperatively, time to first mobilization, opioid use, and pain quality assessment.
- Conditions
- Fibroid Uterus, Pain, Postoperative
- Being tested
- Troacar site infiltration, Superior hypogastric plexus block
- Keywords
- Uterine fibroid, Laparoscopic myomectomy, Postoperative pain, Pre-incisional infiltration, Hypogastric plexus block, EQ-5D questionnaire, Picker questionnaire, The Central Sensitization Inventory (CSI-R)
- Medical subject headings
- Leiomyoma, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Troacar site infiltrationProcedure or surgery
Infiltration of the anterior abdominal wall is performed with placebo or 0.2% ropivacaine diluted with physiological saline on a syringe in the volume of 20 ml - 5 ml for each incision. The drug is injected with a 22-gauge needle at a 90-degree angle.
Superior hypogastric plexus blockProcedure or surgery
At the beginning of the operation the camera is used to visualise the area of the promontorium. Next, a 1 mm laparoscopic puncture needle is inserted through a trocar in the suprapubic region and plunged into the upper part of the formed dome to a depth of no more than 1 cm. After positioning the needle retroperitoneally, an aspiration test is performed to prevent intravascular injection. Then, 20 ml of placebo or 0.2% ropivacaine diluted with physiological saline is slowly injected. At the end of the procedure, the retroperitoneal space swollen by the local anaesthetic is visualised in the promontorium.
| Study group | Role | What they receive |
|---|---|---|
| Standart analgesia | Placebo comparator | Standard postoperative analgesia (systemic non-steroidal anti-inflammatory drugs, paracetamol, opioid analgetics). Receives: Procedure: Troacar site infiltration; Procedure: Superior hypogastric plexus block |
| Troacar site infiltration | Active comparator | Troacar site infiltration without SHP block Receives: Procedure: Troacar site infiltration; Procedure: Superior hypogastric plexus block |
| SHP block | Experimental | Standard systemic analgesia combined with troacar site infiltration and laparoscopic SHP block Receives: Procedure: Troacar site infiltration; Procedure: Superior hypogastric plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Pain syndrome intensity 4 hours after laparoscopic myomectomy. The NRS (Numeric Rating Scale) score from 0-10 is a tool for self-reporting pain intensity, where 0 equals no pain and 10 equals the worst pain imaginable.
Measured: 4 hours postoperatively
Secondary outcomes (4)
Pain Score Dynamics
The NRS (Numeric Rating Scale) score from 0-10 is a tool for self-reporting pain intensity, where 0 equals no pain and 10 equals the worst pain imaginable.
Measured: 2, 6, 8, 12, and 24 hours postoperatively
Mobilization
Timing of post-surgery mobilization (hours after surgery)
Measured: Early postoperative period
Opioid Use
Number of opioid administrations
Measured: Postoperative period, up to 48 hours
Pain Localisation (Superficial/Deep)
Patients were asked to characterize the predominant type of postoperative pain using a standardized questionnaire. Superficial pain was defined as somatic pain (localized, similar to muscle soreness), while deep pain was defined as visceral (diffuse, dull, similar to menstrual pain). Responses were used to evaluate the visceral pain component after surgery. Participants were allowed to report more than one type of postoperative pain.
Measured: Within 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start14 May 2024
- Primary completion26 Jan 2025
- Study completion26 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fibroid UterusStudies 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
- A single-centre prospective randomized placebo-controlled double-blind pilot study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Petersburg State University, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikita Kharlov, Saint Petersburg State University, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429163
- Sponsor's protocol ID
- WINPLEX
- Acronym
- WINPLEX
- Status last verified
- Dec 2025
- First submitted
- 14 May 2024
- Last updated
- 6 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pre-incisional Wound Infiltration and Hypogastric Plexus Block Using Ropivacaine on Postoperative Pain Following Laparoscopic Myomectomy: A Single-Center, Prospective, Randomized, Placebo-Controlled, Double-Blind Study
- ClinicalTrials.gov ID
- NCT06429163
- Acronym / sponsor ID
- WINPLEX / WINPLEX
- Conditions
- Fibroid Uterus, Pain, Postoperative
- Keywords
- Uterine fibroid, Laparoscopic myomectomy, Postoperative pain, Pre-incisional infiltration, Hypogastric plexus block, EQ-5D questionnaire, Picker questionnaire, The Central Sensitization Inventory (CSI-R)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Saint Petersburg State University, RussiaUniversity, hospital or other
- Study start
- 14 May 2024 (actual)
- Primary completion
- 26 Jan 2025 (actual)
- Study completion
- 26 Jan 2025 (actual)
- First posted
- 24 May 2024 (actual)
- Results
- Posted 6 Jan 2026
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 assess an impact of laparoscopic superior hypogastric plexus (SHP) block combined with preemptive troacar site infiltration on postoperative pain intensity following laparoscopic myomectomy.
Detailed description
Patients randomized into 3 groups with a target ratio of 1:1:1 were included in the study: group 1 received standard systemic analgesia combined with troacar site infiltration and laparoscopic SHP block; group 2 received troacar site infiltration without SHP block; control group (group 3) received standard systemic analgesia alone. The primary endpoint was presented by assessing pain intensity using the numeric rating scale (NRS) at 4 hours postoperatively. Secondary endpoints included NRS dynamics at 2, 6, 8, 12, and 24 hours postoperatively, time to first mobilization, opioid use, and pain quality assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- A single-centre prospective randomized placebo-controlled double-blind pilot study
| Arm | Type | Receives |
|---|---|---|
| Standart analgesia | Placebo comparator | Procedure: Troacar site infiltration, Procedure: Superior hypogastric plexus blockStandard postoperative analgesia (systemic non-steroidal anti-inflammatory drugs, paracetamol, opioid analgetics). |
| Troacar site infiltration | Active comparator | Procedure: Troacar site infiltration, Procedure: Superior hypogastric plexus blockTroacar site infiltration without SHP block |
| SHP block | Experimental | Procedure: Troacar site infiltration, Procedure: Superior hypogastric plexus blockStandard systemic analgesia combined with troacar site infiltration and laparoscopic SHP block |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women aged ≥18 years.
- Indication for laparoscopic myomectomy due to ≥6 cm fibroid(s) or multiple fibroids.
- Ability to provide informed consent.
Key exclusion criteria (4 listed)
- FIGO type 7 subserosal pedunculated myoma.
- Conversion to laparotomy.
- Severe presacral adhesions preventing safe SHPB.
- Concomitant pelvic or abdominal surgery.
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 |
|---|---|---|
| Troacar site infiltrationInfiltration of the anterior abdominal wall is performed with placebo or 0.2% ropivacaine diluted with physiological saline on a syringe in the volume of 20 ml - 5 ml for each incision. The drug is injected with a 22-gauge needle at a 90-degree angle. | Procedure or surgery | SHP block, Standart analgesia, Troacar site infiltration |
| Superior hypogastric plexus blockAt the beginning of the operation the camera is used to visualise the area of the promontorium. Next, a 1 mm laparoscopic puncture needle is inserted through a trocar in the suprapubic region and plunged into the upper part of the formed dome to a depth of no more than 1 cm. After positioning the needle retroperitoneally, an aspiration test is performed to prevent intravascular injection. Then, 20 ml of placebo or 0.2% ropivacaine diluted with physiological saline is slowly injected. At the end of the procedure, the retroperitoneal space swollen by the local anaesthetic is visualised in the promontorium. | Procedure or surgery | SHP block, Standart analgesia, Troacar site infiltration |
Primary outcome
Pain Score
Time frame: 4 hours postoperatively
Pain syndrome intensity 4 hours after laparoscopic myomectomy. The NRS (Numeric Rating Scale) score from 0-10 is a tool for self-reporting pain intensity, where 0 equals no pain and 10 equals the worst pain imaginable.
4 secondary outcomes
Pain Score Dynamics
Time frame: 2, 6, 8, 12, and 24 hours postoperatively
Mobilization
Time frame: Early postoperative period
Opioid Use
Time frame: Postoperative period, up to 48 hours
Pain Localisation (Superficial/Deep)
Time frame: Within 48 hours after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Troacar site infiltration and Superior hypogastric plexus block in people with Fibroid Uterus and Pain, Postoperative, run by Saint Petersburg State University, Russia at 1 site in Russia.
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 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 6 Jan 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 Russia. 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?
Yes. Results are posted in the registry (first posted 6 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Score (time frame: 4 hours 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 6 Jan 2026.