Reduced-pressure Pneumoperitoneum and Intraperitoneal Saline Washout to Alleviate Pain Following vNOTES Hysterectomy

NCT06944015 | Not Yet Recruiting Phase 4

• 2 other identifiers: M08250014/60
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Pain, Inflammatory; Pain Management

Outcome Measures

Primary Outcomes (1)

• 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)."

  6 hours after surgery

Study Arms (2)

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.

Other: normal saline

Control Group

NO INTERVENTION

No intervention was performed after the vNOTES

Interventions

normal saline OTHER

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.

Normal Saline

Eligibility Criteria

• Age: Up to 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Erzincan Military Hospital: lead

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Kemal Güngördük

CONTACT

+905054921766; drkemalgungorduk@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 25, 2025
• Study Start: April 24, 2025
• Primary Completion: February 27, 2026
• Study Completion: March 16, 2026
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share