Intraperitoneal Ropivacaine Nebulization for Pain Control After Gynecologic Laparoscopic Surgery
|Ovarian Cysts||Drug: Ropivacaine nebulization Drug: Ropivacaine instillation||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Do Peritoneal Nebulization of Ropivacaine Reduce the Use of Morphine After Short Gynecologic Laparoscopic Surgery?|
- Morphine consumption (mg) [ Time Frame: 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.
- Postoperative Pain [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Four weeks after surgery ]Quality of life will be assessed using the SF-36 questionnaire
|Study Start Date:||April 2010|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Ropivacaine nebulization
Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity
Drug: Ropivacaine nebulization
Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity.
Active Comparator: Ropivacaine instillation
Preoperative instillation of 150 mg of Ropivacaine in the peritoneal cavity before surgery
Drug: Ropivacaine instillation
Preoperative instillation of 150 mg of Ropivacaine in the peritoneal cavity.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01142622
|San Gerardo Hospital|
|Monza, MB, Italy, 20052|
|Principal Investigator:||Pablo M Ingelmo, MD||San Gerardo Hospital, Monza. Italy|