Peritoneal Nebulization of Ropivacaine for Pain Control After Laparoscopic Colectomy

NCT01432496 | Terminated Phase 3

• 1 other identifier: AR HSG 06 2010 Colectomy
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 3

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.

Conditions

Postoperative Pain

Keywords

Laparoscopic; Colectomy; Nebulization; Ropivacaine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time of unassisted walking

  72 hours

• Return to active bowel function

  72 hours

• Hospital morbidity

  72 hours

• Time and condition for hospital discharge

  72 hours

• Analgesic consumption

  72 hours

Study Arms (2)

Ropivacaine 150 mg

EXPERIMENTAL

Nebulization of Ropivacaine 150 mg in the peritoneal cavity with the Aeroneb Pro system

Drug: Ropivacaine 150 mg

Saline 15 ml

PLACEBO COMPARATOR

Nebulization of Saline 15 ml in the peritoneal cavity with the Aeroneb Pro system

Drug: saline 15 ml

Interventions

Ropivacaine 150 mg DRUG

Nebulization of Ropivacaine 150 mg in the peritoneal cavity

Also known as: Nebulization Ropivacaine

Ropivacaine 150 mg

saline 15 ml DRUG

Nebulization of saline 15 ml in the peritoneal cavity

Also known as: Nebulization Saline

Saline 15 ml

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• San Gerardo Hospital: lead
• University of Milano Bicocca: collaborator
• Azienda Ospedaliera di Lecco: collaborator
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator
• University of Pavia: collaborator

Study Sites (3)

Azienda Ospedaliera di Lecco. Presidio "A.Manzoni"

Lecco, LC, 23900, Italy

Location

San Gerardo Hospital

Monza, MB, 20052, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, PV, 27100, Italy

Location

Related 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. doi: 10.1007/s00464-006-9087-6. Epub 2006 Dec 16.

  PMID: 17180268 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.

  PMID: 18633034 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.

  PMID: 18347861 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Pablo M Ingelmo, MD

  San Gerardo Hospital, MB, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anesthesiologys. First Service of Anesthesia and Intensive Care

Study Record Dates

• First Submitted: September 9, 2011
• First Posted: September 13, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 25, 2013

Record last verified: 2013-02

Locations

IT (3)