Local Anesthetic Nebulization and Instillation for Pain Control After Laparoscopic Surgery

This study has been completed.
Sponsor:
Collaborator:
CHU de Hautepierre Strasbourg
Information provided by:
San Gerardo Hospital
ClinicalTrials.gov Identifier:
NCT01248819
First received: November 24, 2010
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

Studies evaluating intraperitoneal local anesthetic instillation for pain relief after laparoscopic procedures have provided conflicting results. This randomized, double-blind study was designed to assess the effects of a novel intraperitoneal local anesthetic administration technique using nebulization on pain relief after laparoscopic cholecystectomy.


Condition Intervention Phase
Laparoscopic Cholecystectomy
Drug: Ropivacaine 60 mg
Drug: Ropivacaine 100 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Blind Randomized Phase III Controlled Trial Comparing the Effect of Intraperitoneal Nebulization of Ropivacaine With Intraperitoneal Instillation of Ropivacaine on Pain Control After Laparoscopic Cholecystectomy

Resource links provided by NLM:


Further study details as provided by San Gerardo Hospital:

Primary Outcome Measures:
  • Postoperative Pain [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Postoperative pain was assessed by Visual analgue scale (VAS 0 to 100 points) at rest (static VAS) and after a deep inspiration or cough (dynamic VAS). The proportion of patients with adequate pain control after surgery (dynamic VAS < 3) will also be assessed.


Secondary Outcome Measures:
  • Morphine consumption (mg) [ Time Frame: Up to 48 hours ] [ Designated as safety issue: No ]
    The total dose of morphine at every evaluation after awakening will be quantified using the PACU clinical chart and/or PCA infusers memory display

  • Time of unassisted walking [ Time Frame: Up to 48 hours ] [ Designated as safety issue: No ]
    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.

  • Hospital morbidity [ Time Frame: Up to 48 hours ] [ Designated as safety issue: Yes ]
    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.

  • Time to hospital discharge [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    We define hospital stay as the elapsed time between surgery and hospital discharge


Enrollment: 60
Study Start Date: April 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Instillation
Instillation of Ropivacaine 100 mg in the abdominal cavity
Drug: Ropivacaine 100 mg
Instillation group received intraperitoneal instillation of ropivacaine 0.5%, 20 ml (100 mg) on the gall bladder after induction of pneumoperitoneum but before dissection of gall bladder plus and intraperitoneal nebulization of normal saline 3 ml before the start of gall bladder dissection and again at the end of surgery just before deflation of pneumoperitoneum. The first saline nebulization was performed over 5-6 minutes using the Aeroneb Pro® device through the umbilical port while the other ports were being inserted, while second nebulization was performed before the withdrawal of the ports
Experimental: Nebulization
Nebulization of Ropivacaine 60 mg in the abdominal cavity
Drug: Ropivacaine 60 mg
Nebulization grou received intraperitoneal instillation of saline 20 ml on the gall bladder after induction of pneumoperitoneum but before dissection of gall bladder plus intraperitoneal nebulization of ropivacaine 1% 3 ml (30 mg) the start of gall bladder dissection and again at the end of surgery just before deflation of pneumoperitoneum (total of 60 mg). The first ropivacaine nebulization was performed over 5-6 minutes using the Aeroneb Pro® device through the umbilical port while the other ports were being inserted, while second nebulization was performed before the withdrawal of the ports

Detailed Description:

Studies evaluating intraperitoneal local anesthetic (LA) instillation for pain relief after laparoscopic cholecystectomy have provided conflicting results. One of the factors that might contribute to failure of the instillation technique may be related to inadequate distribution of local anesthetic throughout the peritoneal surface. In contrast, nebulization should provide a uniform spread of drugs throughout the peritoneal cavity and thus may be beneficial to improve pain relief after laparoscopic procedures. A recent study reported that bupivacaine nebulization significantly reduced pain after laparoscopic cholecystectomy compared with bupivacaine instillation in the gallbladder bed. However, these investigators used a custom-made nebulization system that needs a separate gas source and tubing that is cumbersome and may not be easily available.

Recently, the investigators reported that a microvibration-based nebulization device (Aeroneb Pro® system, Aerogen, Galway, Ireland) could be used for ropivacaine delivery into the insufflation gas required to create pneumorpeitoneum. The investigators hypothesized that intraperitoneal ropivacaine nebulization would provide superior pain relief after laparoscopic cholecystectomy than intraperitoneal ropivacaine instillation. This randomized, double blind, controlled clinical trial was designed to assess the analgesic efficacy of ropivacaine nebulization using the Aeroneb Pro® device laparoscopic cholecystectomy compared with intraperitoneal ropivacaine instillation.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01248819

Locations
Italy
San Gerardo Hospital
Monza, MB, Italy, 20052
Sponsors and Collaborators
San Gerardo Hospital
CHU de Hautepierre Strasbourg
Investigators
Principal Investigator: Pablo M Ingelmo, MD San Gerardo Hospital
  More Information

Publications:
Responsible Party: Pablo M Ingelmo, MD, First Service of anesthesia and intensive care. San Gerardo Hospital
ClinicalTrials.gov Identifier: NCT01248819     History of Changes
Other Study ID Numbers: AR HSG 04-2008
Study First Received: November 24, 2010
Last Updated: November 24, 2010
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by San Gerardo Hospital:
Laparoscopic Cholecystectomy
Nebulization
Ropivacaine

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014