Local Anesthetic Nebulization for Pain Control After Laparoscopic Cholecystectomy

This study has been completed.
Sponsor:
Collaborator:
CHU de Hautepierre Strasbourg
Information provided by:
San Gerardo Hospital
ClinicalTrials.gov Identifier:
NCT01247857
First received: November 23, 2010
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

Intraperitoneal nebulization of local anesthetic is a novel approach to pain management after laparoscopy. Preoperative compared with postoperative administration of analgesia remains controversial. This randomized, double blind, placebo-controlled trial compared the analgesic efficacy of preoperative with postoperative peritoneal ropivacaine nebulization in patients undergoing elective laparoscopic cholecystectomy.


Condition Intervention Phase
Laparoscopic Cholecystectomy
Drug: Ropivacaine 30 mg
Drug: Saline
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 Preoperative and Postoperative Nebulization 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 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). The proportion of patients with adequate pain control after surgery (dynamic NRS < 3) will also be assessed.


Secondary Outcome Measures:
  • 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.

  • 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

  • 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: 90
Study Start Date: April 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Preoperative Nebulization
Nebulization of 30 mg of Ropivacaine in the peritoneal cavity before surgery
Drug: Ropivacaine 30 mg

Intraperitoneal nebulization of ropivacaine 1% 3 ml (30 mg) before surgery and intraperitoneal nebulization of normal saline 3 ml after surgery.

Nebulization was performed over 5-10 minutes using the Aeroneb Pro® device through the umbilical port during the insertion of the other ports, while postoperative nebulization was performed before the withdrawal of the ports.

Active Comparator: Postoperative Nebulization
Nebulization of 30 mg of Ropivacaine in the peritoneal cavity after surgery
Drug: Ropivacaine 30 mg

intraperitoneal Nebulization of normal saline 3 ml before surgery and intraperitoneal nebulization of ropivacaine 1% 3 ml (30 mg) after surgery.

Nebulization was performed over 5-10 minutes using the Aeroneb Pro® device through the umbilical port during the insertion of the other ports, while postoperative nebulization was performed before the withdrawal of the ports.

Placebo Comparator: Control
Nebulization of normal saline 3 ml before and after surgery
Drug: Saline
Intraperitoneal nebulization of normal saline 3 ml before and after surgery. Nebulization was performed over 5-10 minutes using the Aeroneb Pro® device through the umbilical port during the insertion of the other ports, while postoperative nebulization was performed before the withdrawal of the ports.

Detailed Description:

Previous studies evaluating intraperitoneal local anesthetic administration for pain relief after laparoscopic surgery have suggested that the timing of local anesthetic administration may be critical in the success of the technique. A meta-analysis of randomized trials of intraperitoneal local anesthetic instillation in patients undergoing laparoscopic surgery found that local anesthetic instilled before surgical dissection provided superior pain relief compared to instillation at the end of surgery. Intraperitoneal nebulization of local anesthetic is a novel approach to pain management after laparoscopic surgery. Recently, Alkhamesi et al reported that bupivacaine nebulization performed at the end of laparoscopic cholecystectomy significantly reduced postoperative pain. However, clinical benefits of preoperative administration of analgesia, compared with postoperative administration, remains controversial.

The investigators hypothesized that pain relief after preoperative and postoperative ropivacaine nebulization would be similar but better than placebo.

  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: NCT01247857

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: NCT01247857     History of Changes
Other Study ID Numbers: AR HSG 02-2008
Study First Received: November 23, 2010
Last Updated: November 23, 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 September 18, 2014