Clinical trial NCT03290521: Intraperitoneal Lavage for Reducing Pain in Laparoscopy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: pain
laparoscopy
washing
intraperitoneal irrigation
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 277
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will therefore be divided into two groups:

A - Yes Washing (SL) B - No Washing (NL)
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: pain
timeFrame: 17 months
Secondary outcomes:
measure: infections
timeFrame: 17 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Ethics Committee
Study officials:
affiliation: Campus Bio-Medico University
name: Roberto Angioli
role: PRINCIPAL_INVESTIGATOR
References: