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Intraperitoneal Lavage for Reducing Pain in Laparoscopy

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ClinicalTrials.gov Identifier: NCT03290521
Recruitment Status : Completed
First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Roberto Angioli, Campus Bio-Medico University

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Procedure: intraperitoneal washing with saline solution Procedure: No washing Not Applicable

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  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patients will therefore be divided into two groups:

A - Yes Washing (SL) B - No Washing (NL)

Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Role of Intraperitoneal Irrigation and Lavage With Normal Saline for Reduction of Postoperative Pain After Laparoscopic Hysterectomy and Myomectomy: A Randomized Controlled Trial
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : July 30, 2017
Actual Study Completion Date : August 30, 2017

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




Primary Outcome Measures :
  1. pain [ Time Frame: 17 months ]
    to evaluate the postoperative pain using VAS scale


Secondary Outcome Measures :
  1. infections [ Time Frame: 17 months ]
    postoperative infections



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290521


Locations
Italy
Ethics Committee
Rome, Italy, 00128
Sponsors and Collaborators
Campus Bio-Medico University
Investigators
Principal Investigator: Roberto Angioli Campus Bio-Medico University

Responsible Party: Roberto Angioli, Director, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT03290521     History of Changes
Other Study ID Numbers: PAINLESS2812
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Use of intraperitoneal washing to reduce postoperative pain in laparoscopy

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Roberto Angioli, Campus Bio-Medico University:
pain
laparoscopy
washing
intraperitoneal irrigation

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms