Clinical trial NCT01432496: Peritoneal Nebulization of Ropivacaine for Pain Control After Laparoscopic Colectomy
Official title: A Multicentric, Randomized, Controlled, Double Blinded, Phase III Clinical Trial; Comparing Peritoneal Nebulization of Ropivacaine 150 mg With Peritoneal Nebulization of Saline
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Postoperative Pain
Keywords: Laparoscopic
Colectomy
Nebulization
Ropivacaine
Lead sponsor: San Gerardo Hospital
Sponsor class: OTHER
Collaborators: name: University of Milano Bicocca
name: Azienda Ospedaliera di Lecco
name: Fondazione IRCCS Policlinico San Matteo di Pavia
name: University of Pavia
First posted: 2011-09-13
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 150 mg produces better postoperative pain control than Saline nebulization after laparoscopic colectomy.

Detailed description: Recently intraperitoneal nebulization of local anesthetic has been used as an alternative to direct intraperitoneal instillation. Intraperitoneal aerosolization of Bupivacaine 50 mg after laparoscopic cholecystectomy significantly reduced postoperative pain, morphine consumption and incidence of postoperative nausea and vomiting and it is associated with rapid mobilization compared with patients receiving direct instillation of Bupivacaine 50 mg or placebo.

In a recent study the investigators found that nebulization of Ropivacaine 30 mg with the AeronebPro® before or after laparoscopic cholecystectomy and gynecologic laparoscopic surgery reduces postoperative pain and morphine consumption. Patients receiving preoperative nebulization of Ropivacaine presented significantly less postoperative pain (-50% clinical setting) and consumed significant less morphine (-50% and -40% respectively) than patients in control groups during the first 48 hours after surgery.

The effects of peritoneal nebulization of ropivacaine during laparoscopic colectomy on pain control and morphine consumption were not evaluated.

The investigators hypothesize that intraperitoneal nebulization of Ropivacaine may produce better pain control and less morphine consumption than nebulization of saline after laparoscopic colectomy.

Eligibility criteria: Inclusion Criteria:

* Females and Males 18-80 years old
* ASA Score I (American Society of Anesthesiologists classification : a normal healthy patient.
* ASA Score II (American Society of Anesthesiologists classification): A patient with mild systemic disease
* ASA Score III (American Society of Anesthesiologists classification): A patient with severe systemic disease
* Patients scheduled for oncological laparoscopic colectomy
* Patients who do not use opioids analgesic drugs before surgery
* Patients without cognitive impairment or mental retardation

Exclusion Criteria:

* Females and Males under 18 or over 80
* ASA Score IV (American Society of Anesthesiologists classification): A patient with severe systemic disease that is a constant threat to life
* ASA Score V (American Society of Anesthesiologists classification): A moribund patient who is not expected to survive without the operation
* Emergency/urgency surgery
* Postoperative admission in an intensive care unit with sedation or ventilatory assistance
* Cognitive impairment or mental retardation
* Use of opiods before surgery
* Progressive degenerative diseases of the CNS
* Convulsions or chronic therapy with antiepileptic drugs
* Severe hepatic or renal impairment
* Allergy to one of the specific drugs under study
* Acute infection or inflammatory chronic disease
* Alcohol or drug addiction
* Any kind of communication problem
* Neurologic or psychiatric disease

Primary outcomes:
measure: Postoperative pain
timeFrame: 72 hours
Secondary outcomes:
measure: Time of unassisted walking
timeFrame: 72 hours
measure: Return to active bowel function
timeFrame: 72 hours
measure: Hospital morbidity
timeFrame: 72 hours
measure: Time and condition for hospital discharge
timeFrame: 72 hours
measure: Analgesic consumption
timeFrame: 72 hours
Other outcomes:
Locations:
city: Lecco
country: Italy
facility: Azienda Ospedaliera di Lecco. Presidio "A.Manzoni"
state: LC
city: Monza
country: Italy
facility: San Gerardo Hospital
state: MB
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
state: PV
Study officials:
affiliation: San Gerardo Hospital, MB, Italy
name: Pablo M Ingelmo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.