Intraperitoneal Ropivacaine Nebulization for Pain Control After Laparoscopic Surgery

Laparoscopic Cholecystectomy Clinical Trial

Official title:

Peritoneal Nebulization of Ropivacaine for Postoperative Pain Control After Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01143025
• Other study ID #: AR HSG 01 2010
• Status: Completed
• Phase: Phase 3
• First received: June 9, 2010
• Last updated: May 18, 2011
• Start date: March 2010
• Est. completion date: May 2011

Study information

• Verified date: May 2010
• 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 50 mg, 100 mg or 150 mg may prevent the use of morphine during the first day after laparoscopic cholecystectomy.

Description:

Intraperitoneal aerosolization of Bupivacaine 50 mg after laparoscopic cholecystectomy has been proved to significantly reduce postoperative pain, morphine consumption and incidence of postoperative nausea and vomiting in comparison with patients receiving direct instillation of Bupivacaine 50 mg or placebo.

Ropivacaine can be effectively administrated with non-heating nebulizers (AeronebPro®). In a recent study our group found that nebulization of Ropivacaine 30 mg with the AeronebPro® before or after laparoscopic cholecystectomy significantly reduced postoperative pain and morphine consumption. Nonetheless, most patients still need strong opioid based analgesia after surgery.

We hypothesize that intraperitoneal nebulization of Ropivacaine 100 mg and 150 mg (maximum recommended dose in adults 300 mg or up to 3 mg/kg) may prevent the use of morphine during the first day after surgery maintaining ropivacaine plasma levels below toxic concentration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Females and Males 18-75 years old

• ASA Score I-III

• Scheduled for laparoscopic cholecystectomy

• Free from pain in preoperative period

• Not using analgesic drugs before surgery

• Without cognitive impairment or mental retardation

• Written informed consent

Exclusion Criteria:

• Emergency/urgency surgery

• Postoperative admission in an intensive care unit

• Cognitive impairment or mental retardation

• Progressive degenerative diseases of the CNS

• Seizures or chronic therapy with antiepileptic drugs

• Severe hepatic or renal impairment

• Pregnancy or lactation

• Allergy to one of the specific drugs under study

• Acute infection or inflammatory chronic disease

• Alcohol or drug addiction

Study Design

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

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

Drug:
• Ropivacaine 50 mg
Preoperative nebulization of 50 mg of Ropivacaine in the peritoneal cavity
• Ropivacaine 100 mg
Preoperative nebulization of 100 mg of Ropivacaine in the peritoneal cavity
• Ropivacaine 150 mg
Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity

Locations

Country	Name	City	State
Italy	San Gerardo Hospital	Monza	MB

Sponsors (6)

Lead Sponsor	Collaborator
San Gerardo Hospital	Azienda L'ULSS 15 Alta Padovana, Azienda U.S.L. della Valle d'Aosta, Ospedale Regionale Umberto Parini, Gruppo Ospedaliero San Donato, Policlinico San Pietro, Ponte San Pietro, Bergamo, IRCCS Policlinico S. Matteo, University of Milano Bicocca

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 — 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	Morphine consumption (mg)	The total dose of morphine at every evaluation after awakening will be quantified using the PACU clinical chart and/or PCA infusers memory display	Up to 48 hours	No
Secondary	Ropivacaine pharmacokinetics profile: Plasma Concentration of Ropivacaine	We will perform a pharmacokinetic analysis through venous samples collected at 20, 40, 60, 90, 240, and 360 minutes after the end of nebulization.	Up to 360 minutes	Yes
Secondary	Ropivacaine pharmacokinetics profile: Tissue drug analysis	Tissue samples (at least 2 g of tissue) from parietal peritoneum will be taken at the end of surgery . The supernatant will be analised with mass-spectrometry	Up to 2 hours	No
Secondary	Postoperative Pain	Postoperative pain will be assessed by numeric ranking scale (NRS 0 to 10 points) at rest (static NRS) and after a deep inspiration or cough (dynamic NRS). Pain after surgery will be differentiated as abdominal, wall pain, port wound pain and/or shoulder pain. The proportion of patients with adequate pain control after surgery (dynamic NRS < 3) will also be assessed.	Up to 48 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.	Up to 48 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 using the anesthesia charts, surgical charts, surgical database.	Up to 48 hours	Yes
Secondary	Time and condition for hospital discharge	We define hospital stay as the elapsed time between surgery and hospital discharge, in days. We also evaluate the hospital stay with the post-anesthetic discharge scoring system (Modified-PADSS).	Up to 48 hours	No
Secondary	Quality of life after surgery	Quality of life will be assessed using the SF-36 questionnaire	Four weeks after surgery	No