Intraperitoneal Lavage for Reducing Pain in Laparoscopy

NCT03290521 | Completed DMC

• 1 other identifier: PAINLESS2812
• Study Type: interventional
• Target: 277
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to evaluate the role of intraperitoneal washing irrigation with saline solution at the end of laparoscopic hysterectomy or myomectomy in reducing perception of postoperative pain.

Conditions

Pain, Postoperative

Keywords

pain; laparoscopy; washing; intraperitoneal irrigation

Outcome Measures

Primary Outcomes (1)

• pain

  to evaluate the postoperative pain using VAS scale

  17 months

Secondary Outcomes (1)

• infections

  17 months

Study Arms (2)

A - Yes Washing (SL)

EXPERIMENTAL

In this group, the washing process is continued. In particular, 1000cc of laced ringer is instilled by changing the position of the patient in Trendelenburg and Anti-Trendelenburg so that the liquid contacts not only the internal surgical wounds but the whole wall of the abdominal cavity.

Procedure: intraperitoneal washing with saline solution

B- No Washing (NL)

EXPERIMENTAL

No washing was performed before the end of surgery

Procedure: No washing

Interventions

intraperitoneal washing with saline solution PROCEDURE

intraperitoneal washing at the end of surgery

A - Yes Washing (SL)

No washing PROCEDURE

no washing

B- No Washing (NL)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients candidates tor hysterectomy, hysterectomy and annessiectomy, laparoscopic myomectomy;
• ECOG Performance Status between 0 and 1;
• ages between 18 and 70 years
• no present or previous systemic neoplastic disease
• signed informed consent to the operation and execution of the intraperitoneal wash procedure.

You may not qualify if:

• pregnancy,
• pre-existing coagulopathy, neurological or cognitive dysfunction,
• previous or recent pelvic flogosis,
• previous opioid intake for chronic pain,
• previous abdominal surgery,
• previous or current systemic neoplastic disease
• concomitant ovarian and cervical gynecological disease,
• intraoperative conversion from laparoscopy to laparotomy ,
• intraoperative complications,
• use of morphine in the postoperative period,
• ECOG Performance Status \>1.

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

Ethics Committee

Rome, 00128, Italy

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Roberto Angioli

  Campus Bio-Medico University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: Patients will therefore be divided into two groups: A - Yes Washing (SL) B - No Washing (NL)

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 25, 2017
• Study Start: July 1, 2018
• Primary Completion: March 30, 2019
• Study Completion: December 30, 2020
• Last Updated: January 10, 2022

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)