Peritoneal Nebulization of Ropivacaine for Pain Control After Laparoscopic Colectomy

Postoperative Pain Clinical Trial

Official title:

A Multicentric, Randomized, Controlled, Double Blinded, Phase III Clinical Trial; Comparing Peritoneal Nebulization of Ropivacaine 150 mg With Peritoneal Nebulization of Saline

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01432496
• Other study ID #: AR HSG 06 2010 Colectomy
• Status: Terminated
• Phase: Phase 3
• First received: September 9, 2011
• Last updated: February 22, 2013
• Start date: September 2011
• Est. completion date: December 2012

Study information

• Verified date: February 2013
• Source: San Gerardo Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 130
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Ropivacaine 150 mg
Nebulization of Ropivacaine 150 mg in the peritoneal cavity
• saline 15 ml
Nebulization of saline 15 ml in the peritoneal cavity

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera di Lecco. Presidio "A.Manzoni"	Lecco	LC
Italy	San Gerardo Hospital	Monza	MB
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia	PV

Sponsors (5)

Lead Sponsor	Collaborator
San Gerardo Hospital	Azienda Ospedaliera di Lecco, IRCCS Policlinico S. Matteo, University of Milano Bicocca, University of Pavia

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	Numeric Ranking Scale (NRS 0 to 10 points) at rest (static NRS) and after a deep inspiration or cough (dynamic NRS) in PACU and at 6, 24, 48 and 72 hours after the discharge from PACU.	72 hours	No
Secondary	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.	72 hours	No
Secondary	Return to active bowel function	The return of bowel function will be assessed using two parameters: time of first flatus and time of first bowel movement.	72 hours	No
Secondary	Hospital morbidity	All complications or adverse effects associated or possibly associated with the interventions under study, surgery or anesthesia will be quantified	72 hours	Yes
Secondary	Time and condition for hospital discharge	Time in days elapsed between surgery and hospital discharge.	72 hours	No
Secondary	Analgesic consumption	The total dose of morphine will be quantified using the PACU clinical chart and/or PCA infusers memory display	72 hours	No