Pain, InflammatoryPhase 4VnotesNCT06944015
Reduced-pressure Pneumoperitoneum and Intraperitoneal Saline Washout to Alleviate Pain Following vNOTES Hysterectomy
A Phase 4 study testing normal saline in people with Pain, Inflammatory and Pain Management, run by Erzincan Military Hospital.
Trial summary
vNOTES, initially employed for cholecystectomy, appendectomy, and nephrectomy, made its debut in the field of gynecologic surgery in 2012. The advantages of vNOTES-such as minimized postoperative discomfort, quicker recovery, and superior cosmetic results-combined with gynecologists' familiarity with the vaginal… Read more about this study
- Who is it for?
- Ages Up to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Inflammatory, Pain Management
- What is being tested?
- normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- 24 Apr 2025to 16 Mar 2026
- Phase
- Phase 4
- 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 Up to 80 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients who received vNOTES hysterectomy and salpingectomy, with the option of additional procedures such as oophorectomy, uterosacral ligament plications, transobturator tape insertion, colporrhaphy, or sentinel lymphadenectomy.
- ASA status I-III
- Voluntary participation
Who cannot join
- Surgery time greater than 3 h,
- suspected infection or malignancy or rectovaginal endometriosis
- participation in other clinical trials.
- presence of pre-surgical shoulder pain or any acute or chronic pain syndromes
- cognitive impairment or communications disorder,
- previous use of opioids for chronic pain,
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
vNOTES, initially employed for cholecystectomy, appendectomy, and nephrectomy, made its debut in the field of gynecologic surgery in 2012. The advantages of vNOTES-such as minimized postoperative discomfort, quicker recovery, and superior cosmetic results-combined with gynecologists' familiarity with the vaginal approach, have contributed to the swift global adoption of vNOTES in gynecological procedures. Preliminary trials have demonstrated its safety and practicality.
Although laparoscopy plays a crucial role in surgical procedures, post-operative pain remains a major concern linked to this minimally invasive technique, despite being less intense than the pain from a laparotomy. Visceral pain after laparoscopy can stem from the stretching of the peritoneum and diaphragm caused by pneumoperitoneum, as well as from inflammatory cytokines released due to blood accumulation in the abdominal cavity. This pain is typically described as a dull, widespread ache found in the abdominal or thoracic region and often extends to the shoulders. It corresponds to a rise in painkiller use aligned with Enhanced Recovery After Surgery strategies for both preoperative and postoperative stages. Moreover, the Trendelenburg position could intensify shoulder pain due to increased diaphragm irritation from pneumoperitoneum.
Read more
Effective pain management promotes early movement, lowering the risk of blood clots and decreasing lung complications like atelectasis or pneumonia. Additionally, postoperative pain negatively impacts the quality of life immediately after surgery. To lessen both the occurrence and intensity of post-surgical pain, numerous experts advocate for the use of multimodal therapy in surgical patients.
The aim of this study was to evaluate the efficacy of combined low-pressure CO2 pneumoperitoneum and intraperitoneal infusion of normal saline for reducing the incidence and severity of postoperative pain.
- Conditions
- Pain, Inflammatory, Pain Management
- Being tested
- normal saline
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal salineOther
After completion of surgery, Study Group patients underwent intraperitoneal irrigation with 30 mL/kg of normal saline at 37C infused under the right hemidiaphragm. Patients were placed in Trendelenburg position and reverse Trendelenburg position, to allow contact between the liquid and all abdominal structures, including the diaphragm and surgical wounds. At the end of the procedure, all the introduced liquid was carefully removed.
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Experimental | After completion of VNOTE surgery, study Group patients underwent intraperitoneal irrigation with 30 mL/kg of normal saline at 37C infused under the right hemidiaphragm. Patients were placed in Trendelenburg position and reverse Trendelenburg position, to allow contact between the liquid and all abdominal structures, including the diaphragm. At the end of the procedure, the introduced liquid was carefully removed. Receives: Other: normal saline |
| Control Group | No intervention | No intervention was performed after the vNOTES |
What is being measured
The primary outcome is the main question the study is designed to answer.
the visual analogue scale (VAS)
A Visual Analogue Scale (VAS) is an instrument for subjective rating of pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain (0)" and "worst pain (10)."
Measured: 6 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 posted25 Apr 2025
- Study start24 Apr 2025 (estimated)
- Primary completion27 Feb 2026 (estimated)
- Study completion16 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, InflammatoryStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzincan Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kemal GUNGORDUK, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944015
- Sponsor's protocol ID
- M08
- Other IDs
- 250014/60
- Acronym
- Vnotes
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 25 Apr 2025
- 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 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced-pressure Pneumoperitoneum and Intraperitoneal Saline Washout to Alleviate Pain Following vNOTES Hysterectomy
- ClinicalTrials.gov ID
- NCT06944015
- Acronym / sponsor ID
- Vnotes / M08
- Conditions
- Pain, Inflammatory, Pain Management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Erzincan Military HospitalUniversity, hospital or other
- Study start
- 24 Apr 2025 (estimated)
- Primary completion
- 27 Feb 2026 (estimated)
- Study completion
- 16 Mar 2026 (estimated)
- First posted
- 25 Apr 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.
vNOTES, initially employed for cholecystectomy, appendectomy, and nephrectomy, made its debut in the field of gynecologic surgery in 2012. The advantages of vNOTES-such as minimized postoperative discomfort, quicker recovery, and superior cosmetic results-combined with gynecologists' familiarity with the vaginal approach, have contributed to the swift global adoption of vNOTES in gynecological procedures. Preliminary trials have demonstrated its safety and practicality.
Although laparoscopy plays a crucial role in surgical procedures, post-operative pain remains a major concern linked to this minimally invasive technique, despite being less intense than the pain from a laparotomy. Visceral pain after laparoscopy can stem from the stretching of the peritoneum and diaphragm caused by pneumoperitoneum, as well as from inflammatory cytokines released due to blood accumulation in the abdominal cavity. This pain is typically described as a dull, widespread ache found in the abdominal or thoracic region and often extends to the shoulders. It corresponds to a rise in painkiller use aligned with Enhanced Recovery After Surgery strategies for both preoperative and postoperative stages. Moreover, the Trendelenburg position could intensify shoulder pain due to increased diaphragm irritation from pneumoperitoneum.
Effective pain management promotes early movement, lowering the risk of blood clots and decreasing lung complications like atelectasis or pneumonia. Additionally, postoperative pain negatively impacts the quality of life immediately after surgery. To lessen both the occurrence and intensity of post-surgical pain, numerous experts advocate for the use of multimodal therapy in surgical patients.
The aim of this study was to evaluate the efficacy of combined low-pressure CO2 pneumoperitoneum and intraperitoneal infusion of normal saline for reducing the incidence and severity of postoperative pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Experimental | Other: normal salineAfter completion of VNOTE surgery, study Group patients underwent intraperitoneal irrigation with 30 mL/kg of normal saline at 37C infused under the right hemidiaphragm. Patients were placed in Trendelenburg position and reverse Trendelenburg position, to allow contact between the liquid and all abdominal structures, including the diaphragm. At the end of the procedure, the introduced liquid was carefully removed. |
| Control Group | No intervention | –No intervention was performed after the vNOTES |
Who may qualify
- Ages
- Up to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who received vNOTES hysterectomy and salpingectomy, with the option of additional procedures such as oophorectomy, uterosacral ligament plications, transobturator tape insertion, colporrhaphy, or sentinel lymphadenectomy.
- ASA status I-III
- Voluntary participation
Key exclusion criteria (6 listed)
- Surgery time greater than 3 h,
- suspected infection or malignancy or rectovaginal endometriosis
- participation in other clinical trials.
- presence of pre-surgical shoulder pain or any acute or chronic pain syndromes
- cognitive impairment or communications 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 |
|---|---|---|
| normal salineAfter completion of surgery, Study Group patients underwent intraperitoneal irrigation with 30 mL/kg of normal saline at 37C infused under the right hemidiaphragm. Patients were placed in Trendelenburg position and reverse Trendelenburg position, to allow contact between the liquid and all abdominal structures, including the diaphragm and surgical wounds. At the end of the procedure, all the introduced liquid was carefully removed. | Other | Normal Saline |
Primary outcome
the visual analogue scale (VAS)
Time frame: 6 hours after surgery
A Visual Analogue Scale (VAS) is an instrument for subjective rating of pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain (0)" and "worst pain (10)."
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 25 Apr 2025.
- 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 Phase 4 study testing normal saline in people with Pain, Inflammatory and Pain Management, run by Erzincan Military Hospital.
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: opening soon, as of the sponsor's last update on 25 Apr 2025. 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. 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?
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 Kemal Güngördük (+905054921766, drkemalgungorduk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the visual analogue scale (VAS) (time frame: 6 hours after 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 25 Apr 2025.