Intraperitoneal Ropivacaine Nebulization for Pain Control After Laparoscopic Surgery

Peritoneal Nebulization of Ropivacaine for Postoperative Pain Control After Laparoscopic Cholecystectomy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01143025

Enrollment

165

Registered

2010-06-14

Start date

2010-03-31

Completion date

2011-05-31

Last updated

2011-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Cholecystectomy

Keywords

Laparoscopic Cholecystectomy, Nebulization, Ropivacaine

Brief 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.

Detailed 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.

Interventions

DRUGRopivacaine 50 mg

Preoperative nebulization of 50 mg of Ropivacaine in the peritoneal cavity

DRUGRopivacaine 100 mg

Preoperative nebulization of 100 mg of Ropivacaine in the peritoneal cavity

DRUGRopivacaine 150 mg

Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Morphine consumption (mg)	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

Measure	Time frame	Description
Ropivacaine pharmacokinetics profile: Tissue drug analysis	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
Postoperative Pain	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.
Time of unassisted walking	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.
Ropivacaine pharmacokinetics profile: Plasma Concentration of Ropivacaine	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.
Time and condition for hospital discharge	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).
Quality of life after surgery	Four weeks after surgery	Quality of life will be assessed using the SF-36 questionnaire
Hospital morbidity	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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026