Intraperitoneal Lavage for Reducing Pain in Laparoscopy

NCT ID: NCT03290521

Last Updated: 2022-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 277 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2020-12-30

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.

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

intraperitoneal washing with saline solution

Intervention Type: PROCEDURE

intraperitoneal washing at the end of surgery

B- No Washing (NL)

No washing was performed before the end of surgery

Group Type: EXPERIMENTAL

No washing

Intervention Type: PROCEDURE

no washing

Interventions

intraperitoneal washing with saline solution

intraperitoneal washing at the end of surgery

Intervention Type: PROCEDURE

No washing

no washing

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Campus Bio-Medico University

OTHER

Sponsor Role: lead

Responsible Party

Roberto Angioli

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberto Angioli

Role: PRINCIPAL_INVESTIGATOR

Campus Bio-Medico University

Locations

Ethics Committee

Rome, , Italy

Countries

Italy

Other Identifiers

PAINLESS2812

Identifier Type: -

Identifier Source: org_study_id