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Laparoscopic CholecystectomyPhase 3NCT01143025

Intraperitoneal Ropivacaine Nebulization for Pain Control After Laparoscopic Surgery

A Phase 3 study testing Ropivacaine 50 mg, Ropivacaine 100 mg and Ropivacaine 150 mg in people with Laparoscopic Cholecystectomy, run by San Gerardo Hospital at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Laparoscopic Cholecystectomy
What is being tested?
Ropivacaine 50 mg, Ropivacaine 100 mg and Ropivacaine 150 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
165 participants
Where
1 siteItaly
Study dates
Mar 2010to May 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Pregnancy or lactation
  • Allergy to one of the specific drugs under study
  • Acute infection or inflammatory chronic disease
  • Alcohol or drug addiction

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • San Gerardo Hospital

    Monza, MB, 20052

Other trials in Italy

About this study

Official title: Peritoneal Nebulization of Ropivacaine for Postoperative Pain Control After Laparoscopic Cholecystectomy

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.

Read the 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.

Being tested
Ropivacaine 50 mg, Ropivacaine 100 mg, Ropivacaine 150 mg
Keywords
Laparoscopic Cholecystectomy, Nebulization, Ropivacaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ropivacaine 50 mgDrug

    Also called Nebulization, Ropivacaine

    Preoperative nebulization of 50 mg of Ropivacaine in the peritoneal cavity

  • Ropivacaine 100 mgDrug

    Also called Nebulization, Ropivacaine

    Preoperative nebulization of 100 mg of Ropivacaine in the peritoneal cavity

  • Ropivacaine 150 mgDrug

    Also called Nebulization, Ropivacaine

    Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity

Study groups in NCT01143025
Study groupRoleWhat they receive
Ropivacaine 50 mgActive comparatorPreoperative nebulization of 50 mg of Ropivacaine in the peritoneal cavity
Receives: Drug: Ropivacaine 50 mg
Ropivacaine 100 mgExperimentalPreoperative nebulization of 100 mg of Ropivacaine in the peritoneal cavity
Receives: Drug: Ropivacaine 100 mg
Ropivacaine 150 mgExperimentalPreoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity
Receives: Drug: Ropivacaine 150 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Morphine consumption (mg)

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

    Measured: Up to 48 hours

Secondary outcomes (7)

  1. Ropivacaine pharmacokinetics profile: Plasma Concentration of Ropivacaine

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

    Measured: Up to 360 minutes

  2. Ropivacaine pharmacokinetics profile: Tissue drug analysis

    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

    Measured: Up to 2 hours

  3. Postoperative Pain

    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.

    Measured: Up to 48 hours

  4. Time of unassisted walking

    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.

    Measured: Up to 48 hours

  5. Hospital morbidity

    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.

    Measured: Up to 48 hours

  6. Time and condition for hospital discharge

    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).

    Measured: Up to 48 hours

  7. Quality of life after surgery

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

    Measured: Four weeks after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionApr 2011
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
165 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01143025
Sponsor's protocol ID
AR HSG 01 2010
Status last verified
May 2010
First submitted
9 Jun 2010
Last updated
19 May 2011
Results posted
No
Data monitoring committee
No

Publications

  • Greib N, Schlotterbeck H, Dow WA, Joshi GP, Geny B, Diemunsch PA. An evaluation of gas humidifying devices as a means of intraperitoneal local anesthetic administration for laparoscopic surgery. Anesth Analg. 2008 Aug;107(2):549-51. doi: 10.1213/ane.0b013e318176fa1c.

    PubMed 18633034

  • Schlotterbeck H, Schaeffer R, Dow WA, Diemunsch P. Cold nebulization used to prevent heat loss during laparoscopic surgery: an experimental study in pigs. Surg Endosc. 2008 Dec;22(12):2616-20. doi: 10.1007/s00464-008-9841-z. Epub 2008 Mar 18.

    PubMed 18347861

  • Alkhamesi NA, Peck DH, Lomax D, Darzi AW. Intraperitoneal aerosolization of bupivacaine reduces postoperative pain in laparoscopic surgery: a randomized prospective controlled double-blinded clinical trial. Surg Endosc. 2007 Apr;21(4):602-6. doi: 10.1007/s00464-006-9087-6. Epub 2006 Dec 16.

    PubMed 17180268

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ropivacaine 50 mg, Ropivacaine 100 mg and Ropivacaine 150 mg in people with Laparoscopic Cholecystectomy, run by San Gerardo Hospital at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Morphine consumption (mg) (time frame: Up to 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01143025, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2011.

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