Impact of Intraperitonael Nebulization of Local Anesthetic on Postoperative Pain Associated With Laparoscopic Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pablo Mauricio Ingelmo M.D., San Gerardo Hospital
ClinicalTrials.gov Identifier:
NCT01512914
First received: January 15, 2012
Last updated: January 18, 2012
Last verified: January 2012
  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 gynecologic laparoscopic surgery.


Condition Intervention Phase
Gynecologic Laparoscopic Surgery
Drug: Ropivacaine 30 mg
Drug: Ropivacaine 100 mg
Drug: saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Intraperitonael Nebulization of Local Anesthetic on Postoperative Pain Associated With Laparoscopic Surgery

Resource links provided by NLM:


Further study details as provided by San Gerardo Hospital:

Primary Outcome Measures:
  • postoperative pain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Postoperative pain was assessed by NRS (0 to 10 points) at rest (static NRS) and after a deep inspiration or cough (dynamic NRS). The proportion of patients with adequate pain control after surgery (dynamic NRS < 3) will also be assessed.


Secondary Outcome Measures:
  • morphine consumption [ Time Frame: 24 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

  • Unassisted walking time [ Time Frame: 24 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 stay [ Time Frame: between surgery and discharge ] [ Designated as safety issue: No ]
    We define hospital stay as the elapsed time between surgery and hospital discharge

  • hospital morbidity [ Time Frame: up to discharge ] [ Designated as safety issue: No ]
    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.


Enrollment: 120
Study Start Date: May 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: CONTROL group Drug: saline
preoperative instillation of saline 20 ml and nebulization of saline before and after surgery
Experimental: PREOPERATIVE nebulization Drug: Ropivacaine 30 mg
preoperative instillation of saline 20 ml, nebulization of ropivacaine 1% 3 ml (30 mg) before surgery and nebulization of saline 3 ml after surgery
Experimental: POSTOPERATIVE nebulization Drug: Ropivacaine 30 mg
preoperative instillation of saline 20 ml, preoperative nebulization of saline 3 ml and nebulization of ropivacaine 1% 3 ml (30 mg) after surgery
Active Comparator: INSTILLATION group Drug: Ropivacaine 100 mg
preoperative instillation of ropivacaine 0,5% 20 ml (100 mg) and nebulization of saline 3 ml before and after surgery

Detailed Description:

Studies evaluating intraperitoneal local anesthetic (LA) instillation for pain relief after laparoscopic surgery 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. 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 than ropivacaine instillation after gynecologic laparoscopic surgery. This randomized, double blind, controlled clinical trial was designed to assess the analgesic efficacy of ropivacaine nebulization before or after surgery compared with intraperitoneal ropivacaine instillation and placebo after gynecologic laparoscopic procedures.

  Eligibility

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

Inclusion Criteria:

  • Females 18-70 years old, ASA score 1 - 3;
  • scheduled for laparoscopic operative surgery in the Obstetrics and Gynecology unit;
  • free from pain in preoperative period, without habitual analgesic use;
  • without cognitive impairment or mental retardation, who gave a written informed consent

Exclusion Criteria:

  • Females under 18 or over 70;
  • ASA 4 or 5;
  • emergency/urgency criteria, postoperative admission in a intensive care unit with sedation or ventilatory assistance; cognitive impairment or mental retardation;
  • habitual analgesic use; progressive degenerative diseases of the CNS;
  • convulsions or chronic therapy with antiepileptic drugs;
  • severe hepatic or renal impairment;
  • pregnancy or lactation;
  • allergy to one of the specific substances used in the study;
  • acute infectious disease or inflammatory chronic disease, alcohol or drug addiction;
  • any kind of communication problem;
  • neurologic or psychiatric disease;
  • no written informed consent
  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: NCT01512914

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

Publications:
Responsible Party: Pablo Mauricio Ingelmo M.D., MD, San Gerardo Hospital
ClinicalTrials.gov Identifier: NCT01512914     History of Changes
Other Study ID Numbers: AR HSG 01-2008
Study First Received: January 15, 2012
Last Updated: January 18, 2012
Health Authority: Italy: Ethics Committee
Italy: The Italian Medicines Agency

Keywords provided by San Gerardo Hospital:
Gynecologic laparoscopic surgery
Postoperative pain
Nebulization
Ropivacaine

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics, Local
Ropivacaine
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 August 01, 2014