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

Overview

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.

Interventions

• Other normal saline
  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.

Primary outcome measures

• the visual analogue scale (VAS) [Time frame: 6 hours after surgery]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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,

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06944015 · M08 · 250014/60

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗