Intraperitoneal Ropivacaine Nebulization for Pain Control After Laparoscopic Surgery

Last updated: May 18, 2011
Sponsor: San Gerardo Hospital
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT01143025
AR HSG 01 2010
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 165
Study Start date:
March 01, 2010
Estimated Completion Date:
May 31, 2011

Study 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.

Connect with a study center

  • San Gerardo Hospital

    Monza, MB 20052
    Italy

    Site Not Available

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