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| Name | Class |
|---|---|
| A.O. Ospedale Papa Giovanni XXIII | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine nebulization | Experimental | Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity |
|
| Ropivacaine instillation | Active Comparator | Preoperative instillation of 150 mg of Ropivacaine in the peritoneal cavity before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine nebulization | Drug | Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo M Ingelmo, MD | San Gerardo Hospital, Monza. Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Gerardo Hospital | Monza | MB | 20052 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18633034 | Background | Greib N, Schlotterbeck H, Dow WA, Joshi GP, Geny B, Diemunsch PA. An evaluation of gas humidifying devices as a means of intraperitoneal local anesthetic administration for laparoscopic surgery. Anesth Analg. 2008 Aug;107(2):549-51. doi: 10.1213/ane.0b013e318176fa1c. | |
| 17180268 | Background | Alkhamesi NA, Peck DH, Lomax D, Darzi AW. Intraperitoneal aerosolization of bupivacaine reduces postoperative pain in laparoscopic surgery: a randomized prospective controlled double-blinded clinical trial. Surg Endosc. 2007 Apr;21(4):602-6. doi: 10.1007/s00464-006-9087-6. Epub 2006 Dec 16. |
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| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Ropivacaine instillation | Drug | Preoperative instillation of 150 mg of Ropivacaine in the peritoneal cavity. |
|
|
| 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. | 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. | 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). | Up to 24 hours |
| Quality of life after surgery | Quality of life will be assessed using the SF-36 questionnaire | Four weeks after surgery |
| 18347861 | Background | Schlotterbeck H, Schaeffer R, Dow WA, Diemunsch P. Cold nebulization used to prevent heat loss during laparoscopic surgery: an experimental study in pigs. Surg Endosc. 2008 Dec;22(12):2616-20. doi: 10.1007/s00464-008-9841-z. Epub 2008 Mar 18. |
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D000588 |
| Amines |