Ovarian Cysts
Conditions
Keywords
Ovarian Cysts, Nebulization, Ropivacaine
Brief summary
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.
Detailed description
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.
Interventions
DRUGRopivacaine nebulization
Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity.
DRUGRopivacaine instillation
Preoperative instillation of 150 mg of Ropivacaine in the peritoneal cavity.
Sponsors
A.O. Ospedale Papa Giovanni XXIII
San Gerardo Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine consumption (mg) | Up to 24 hours | The total dose of morphine at every evaluation after awakening will be quantified using the PACU clinical chart and/or PCA infusers memory display. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | Up to 24 hours | 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 of unassisted walking | Up to 24 hours | 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. |
| Hospital morbidity | Up to 24 hours | 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. |
| Hospital stay | Up to 24 hours | 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). |
| Quality of life after surgery | Four weeks after surgery | Quality of life will be assessed using the SF-36 questionnaire |
Countries
Italy
Outcome results
None listed