Peritoneal Nebulization of Ropivacaine for Pain Control After Laparoscopic Colectomy

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

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.

Study Overview

• Status: Terminated
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Ropivacaine 150 mg; Drug: saline 15 ml

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.

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • LC
    • Lecco, LC, Italy, 23900
      • Azienda Ospedaliera di Lecco. Presidio "A.Manzoni"
  • MB
    • Monza, MB, Italy, 20052
      • San Gerardo Hospital
  • PV
    • Pavia, PV, Italy, 27100
      • Fondazione IRCCS Policlinico San Matteo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ropivacaine 150 mg; Nebulization of Ropivacaine 150 mg in the peritoneal cavity with the Aeroneb Pro system	Drug: Ropivacaine 150 mg; Nebulization of Ropivacaine 150 mg in the peritoneal cavity; Other Names: Nebulization Ropivacaine
PLACEBO_COMPARATOR: Saline 15 ml; Nebulization of Saline 15 ml in the peritoneal cavity with the Aeroneb Pro system	Drug: saline 15 ml; Nebulization of saline 15 ml in the peritoneal cavity; Other Names: Nebulization Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Hospital morbidity	All complications or adverse effects associated or possibly associated with the interventions under study, surgery or anesthesia will be quantified	72 hours
Time and condition for hospital discharge	Time in days elapsed between surgery and hospital discharge.	72 hours
Analgesic consumption	The total dose of morphine will be quantified using the PACU clinical chart and/or PCA infusers memory display	72 hours

Collaborators and Investigators

• Sponsor: San Gerardo Hospital
• Collaborators: University of Pavia; IRCCS Policlinico S. Matteo; University of Milano Bicocca; Azienda Ospedaliera di Lecco
• Investigators: Principal Investigator: Pablo M Ingelmo, MD, San Gerardo Hospital, MB, Italy

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: September 9, 2011
• First Submitted That Met QC Criteria: September 12, 2011
• First Posted (ESTIMATE): September 13, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): February 25, 2013
• Last Update Submitted That Met QC Criteria: February 22, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Laparoscopic; Colectomy; Nebulization; Ropivacaine
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: AR HSG 06 2010 Colectomy