Intraperitoneal Lavage for Reducing Pain in Laparoscopy

December 17, 2021 updated by: Roberto Angioli, Campus Bio-Medico University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
277

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00128
        • Ethics Committee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pain
Time Frame: 17 months
to evaluate the postoperative pain using VAS scale
17 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
infections
Time Frame: 17 months
postoperative infections
17 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Campus Bio-Medico University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Roberto Angioli, Campus Bio-Medico University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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