Intraperitoneal Ropivacaine Nebulization for Pain Control After Gynecologic Laparoscopic Surgery
- Conditions
- Ovarian Cysts
- Interventions
- Registration Number
- NCT01142622
- Lead Sponsor
- San Gerardo Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 140
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ropivacaine nebulization Ropivacaine nebulization Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity Ropivacaine instillation Ropivacaine instillation Preoperative instillation of 150 mg of Ropivacaine in the peritoneal cavity before surgery
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
San Gerardo Hospital
🇮🇹Monza, MB, Italy