Intraperitoneal Ropivacaine Nebulization for Pain Control After Gynecologic Laparoscopic Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
Other Names:
|
| 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Females 18-65 years old
-
ASA Score I-III
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Scheduled for ovarian cyst laparoscopic surgery
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Free from pain in preoperative period
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Not using analgesic drugs before surgery
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Without cognitive impairment or mental retardation
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Written informed consent
Exclusion Criteria:
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Emergency/urgency surgery
-
Postoperative admission in an intensive care unit
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Cognitive impairment or mental retardation
-
Progressive degenerative diseases of the CNS
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Seizures or chronic therapy with antiepileptic drugs
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Severe hepatic or renal impairment
-
Pregnancy or lactation
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Allergy to one of the specific drugs under study
-
Acute infection or inflammatory chronic disease
-
Alcohol or drug addiction
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | San Gerardo Hospital | Monza | MB | Italy | 20052 |
Sponsors and Collaborators
- San Gerardo Hospital
- A.O. Ospedale Papa Giovanni XXIII
Investigators
- Principal Investigator: Pablo M Ingelmo, MD, San Gerardo Hospital, Monza. Italy
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Epub 2006 Dec 16.
- 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.
- 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.
- AR HSG 02 2010 Ovarian Cyst