Intraperitoneal Lavage for Reducing Pain in Laparoscopy

The Role of Intraperitoneal Irrigation and Lavage With Normal Saline for Reduction of Postoperative Pain After Laparoscopic Hysterectomy and Myomectomy: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Procedure: intraperitoneal washing with saline solution; Procedure: No washing

Detailed Description

Patients will be fully and accurately informed on the type of intervention and will sign a specific informed consent, in accordance with CBM standards, both for the intervention to which the patient will undergo both for the study in question.

Randomization will be performed through a randomized randomization table generated by a computer. Patients will therefore be divided into two groups:

A - Yes Washing (SL) B - No Washing (NL) Prior to surgery, hemoglobin and PCR values will be evaluated in the preoperative.

Prior to the incision, an antibiotic prophylaxis will be performed with cefazoline 2gr intravenously.

The intervention in both groups involves the periombelic cutaneous incision and the sub-umbilical band. Introduction of 10mm led trocar based on open technique. The introduction of optics and CO2 insufflation allows the macroscopic visualization of the endotominal organs. The investigators proceed with the introduction of 3 additional 3-lane trocar accessories in the left iliac fossa, right and overlaid iliac thorax. You will perform a hysterectomy possibly associated with annessiectomy or myomectomy according to the surgical indication. Careful hemostasis is carried out. In the SL 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. The surgery ends with the closure of the band and the breasts cutaneous. The parameters measured during the operation are: operating time, amount of CO2 injected (L), pneumoperitoneal pressure (mmHg). The operator surgeon is always the same.

In the postoperative period, the following parameters will be evaluated: hemoglobin, white blood cells, PCR, body temperature, recovery of intestinal activity, administration of toradol, paracetamol and possible morphine and postoperative postoperative pain, palpation, cough. The latter is evaluated through tables using the VAS visual scale: patients report the subjective characteristics of perceived postoperative pain by attributing a value of 0 (no pain) to 10 (worse pain than I can imagine). It assesses the occurrence of any complications in post-operative, infection and fever, which may require the patient's exclusion from the study.

• Study Type: Interventional
• Enrollment (Actual): 277
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00128
    • Ethics Committee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A - Yes Washing (SL); 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; intraperitoneal washing at the end of surgery
Experimental: B- No Washing (NL); No washing was performed before the end of surgery	Procedure: No washing; no washing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain	to evaluate the postoperative pain using VAS scale	17 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
infections	postoperative infections	17 months

Collaborators and Investigators

• Sponsor: Campus Bio-Medico University
• Investigators: Principal Investigator: Roberto Angioli, Campus Bio-Medico University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): March 30, 2019
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Actual): January 10, 2022
• Last Update Submitted That Met QC Criteria: December 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: pain; laparoscopy; washing; intraperitoneal irrigation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: PAINLESS2812

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Use of intraperitoneal washing to reduce postoperative pain in laparoscopy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No