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Completed

NCT Number: NCT01143025

Intraperitoneal Ropivacaine Nebulization for Pain Control After Laparoscopic Surgery

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.

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Key information

Conditions

Laparoscopic Cholecystectomy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

San Gerardo Hospital

Monza, MB, 20052, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine 50 mg

Drug

Preoperative nebulization of 50 mg of Ropivacaine in the peritoneal cavity

Other names: Nebulization, Ropivacaine

Ropivacaine 100 mg

Drug

Preoperative nebulization of 100 mg of Ropivacaine in the peritoneal cavity

Other names: Nebulization, Ropivacaine

Ropivacaine 150 mg

Drug

Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity

Other names: Nebulization, Ropivacaine

Primary outcomes

  1. Morphine consumption (mg)

    Time frame: Up to 48 hours

    The total dose of morphine at every evaluation after awakening will be quantified using the PACU clinical chart and/or PCA infusers memory display

Secondary outcomes

  1. Ropivacaine pharmacokinetics profile: Plasma Concentration of Ropivacaine

    Time frame: Up to 360 minutes

    We will perform a pharmacokinetic analysis through venous samples collected at 20, 40, 60, 90, 240, and 360 minutes after the end of nebulization.

  2. Ropivacaine pharmacokinetics profile: Tissue drug analysis

    Time frame: Up to 2 hours

    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

  3. Postoperative Pain

    Time frame: Up to 48 hours

    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.

  4. Time of unassisted walking

    Time frame: Up to 48 hours

    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.

  5. Hospital morbidity

    Time frame: Up to 48 hours

    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.

  6. Time and condition for hospital discharge

    Time frame: Up to 48 hours

    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).

  7. Quality of life after surgery

    Time frame: Four weeks after surgery

    Quality of life will be assessed using the SF-36 questionnaire

Sponsors and collaborators

Lead sponsor

San Gerardo Hospital

Other

Collaborators

  • Azienda L'ULSS 15 Alta Padovana
  • Azienda U.S.L. della Valle d'Aosta, Ospedale Regionale Umberto Parini
  • Fondazione IRCCS Policlinico San Matteo di Pavia
  • Gruppo Ospedaliero San Donato, Policlinico San Pietro, Ponte San Pietro, Bergamo
  • University of Milano Bicocca

Registry information

Official study title

Peritoneal Nebulization of Ropivacaine for Postoperative Pain Control After Laparoscopic Cholecystectomy

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 14, 2010
Registry last updated
May 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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