Intraperitoneal Ropivacaine Nebulization for Pain Control After Gynecologic Laparoscopic Surgery

San Gerardo Hospital140 enrolled

Overview

The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 150 mg may prevent the use of morphine during the first day after laparoscopic ovarian cyst surgery.

In a recent study the investigators found that nebulization of Ropivacaine 30 mg before or after gynaecologic laparoscopic surgery significantly reduces postoperative pain and postoperative morphine consumption. Ropivacaine was effectively administered with non-heating nebulizers (AeronebPro®). However, almost all patients still use morphine after surgery. The investigators hypothesize that intraperitoneal nebulization of Ropivacaine 150 mg may prevent the use of morphine after the laparoscopic ovarian cyst surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

140

Conditions

Ovarian Cysts

Interventions

Ropivacaine nebulizationDRUG

Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity.

Ropivacaine instillationDRUG

Preoperative instillation of 150 mg of Ropivacaine in the peritoneal cavity.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Females 18-65 years old * ASA Score I-III * Scheduled for ovarian cyst laparoscopic surgery * Free from pain in preoperative period * Not using analgesic drugs before surgery * Without cognitive impairment or mental retardation * Written informed consent Exclusion Criteria: * Emergency/urgency surgery * Postoperative admission in an intensive care unit * Cognitive impairment or mental retardation * Progressive degenerative diseases of the CNS * Seizures or chronic therapy with antiepileptic drugs * Severe hepatic or renal impairment * Pregnancy or lactation * Allergy to one of the specific drugs under study * Acute infection or inflammatory chronic disease * Alcohol or drug addiction

Locations (1)

San Gerardo Hospital

Monza, MB, Italy

Outcomes

Primary Outcomes

Morphine consumption (mg)

The total dose of morphine at every evaluation after awakening will be quantified using the PACU clinical chart and/or PCA infusers memory display.

Time frame: Up to 24 hours

Secondary Outcomes

Postoperative Pain

Postoperative pain will be assessed by numeric ranking scale (NRS 0 to 10 points) at rest (static NRS) and after deep inspiration or cough (dynamic NRS). Pain after surgery will be differentiated as abdominal, wall pain, port wound pain, back pain and shoulder pain. The proportion of patients with adequate pain control after surgery (dynamic NRS \< 3) will also be assessed.

Time frame: Up to 24 hours

Time of unassisted walking

Unassisted walking time is defined as the time in hours between PACU discharge and when the patient is able to walk out of his room and back to bed without any assistance.

Time frame: Up to 24 hours

Hospital morbidity

All complications or adverse effects associated or possibly associated with the interventions under study, surgery or anesthesia, will be quantified using the anesthesia charts, surgical charts and surgical database.

Time frame: Up to 24 hours

Hospital stay

We define hospital stay as the time in hours elapsed between surgery and hospital discharge. We evaluate the hospital stay with the post-anesthetic discharge scoring system (Modified-PADSS).

Time frame: Up to 24 hours

Quality of life after surgery

Quality of life will be assessed using the SF-36 questionnaire

Time frame: Four weeks after surgery

Data from ClinicalTrials.gov

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