Postoperative PainPhase 3NCT01432496
Peritoneal Nebulization of Ropivacaine for Pain Control After Laparoscopic Colectomy
A Phase 3 study testing Ropivacaine 150 mg and saline 15 ml in people with Postoperative Pain, run by San Gerardo Hospital at 3 sites in Italy.
Trial summary
The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 150 mg produces better postoperative pain control than Saline nebulization after laparoscopic colectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ropivacaine 150 mg and saline 15 ml
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 3 sitesItaly
- Study dates
- Sep 2011to Dec 2012
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females and Males 18-80 years old
- ASA Score I (American Society of Anesthesiologists classification : a normal healthy patient.
- ASA Score II (American Society of Anesthesiologists classification): A patient with mild systemic disease
- ASA Score III (American Society of Anesthesiologists classification): A patient with severe systemic disease
- Patients scheduled for oncological laparoscopic colectomy
- Patients who do not use opioids analgesic drugs before surgery
- Patients without cognitive impairment or mental retardation
Who cannot join
- Females and Males under 18 or over 80
- ASA Score IV (American Society of Anesthesiologists classification): A patient with severe systemic disease that is a constant threat to life
- ASA Score V (American Society of Anesthesiologists classification): A moribund patient who is not expected to survive without the operation
- Emergency/urgency surgery
- Postoperative admission in an intensive care unit with sedation or ventilatory assistance
- Cognitive impairment or mental retardation
Show all 15Show fewer
- Use of opiods before surgery
- Progressive degenerative diseases of the CNS
- Convulsions or chronic therapy with antiepileptic drugs
- Severe hepatic or renal impairment
- Allergy to one of the specific drugs under study
- Acute infection or inflammatory chronic disease
- Alcohol or drug addiction
- Any kind of communication problem
- Neurologic or psychiatric disease
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Azienda Ospedaliera di Lecco. Presidio "A.Manzoni"
Lecco, LC, 23900
San Gerardo Hospital
Monza, MB, 20052
Fondazione IRCCS Policlinico San Matteo
Pavia, PV, 27100
About this study
Official title: A Multicentric, Randomized, Controlled, Double Blinded, Phase III Clinical Trial; Comparing Peritoneal Nebulization of Ropivacaine 150 mg With Peritoneal Nebulization of Saline
The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 150 mg produces better postoperative pain control than Saline nebulization after laparoscopic colectomy.
Read the detailed description
Recently intraperitoneal nebulization of local anesthetic has been used as an alternative to direct intraperitoneal instillation. Intraperitoneal aerosolization of Bupivacaine 50 mg after laparoscopic cholecystectomy significantly reduced postoperative pain, morphine consumption and incidence of postoperative nausea and vomiting and it is associated with rapid mobilization compared with patients receiving direct instillation of Bupivacaine 50 mg or placebo.
In a recent study the investigators found that nebulization of Ropivacaine 30 mg with the AeronebPro® before or after laparoscopic cholecystectomy and gynecologic laparoscopic surgery reduces postoperative pain and morphine consumption. Patients receiving preoperative nebulization of Ropivacaine presented significantly less postoperative pain (-50% clinical setting) and consumed significant less morphine (-50% and -40% respectively) than patients in control groups during the first 48 hours after surgery.
The effects of peritoneal nebulization of ropivacaine during laparoscopic colectomy on pain control and morphine consumption were not evaluated.
The investigators hypothesize that intraperitoneal nebulization of Ropivacaine may produce better pain control and less morphine consumption than nebulization of saline after laparoscopic colectomy.
- Conditions
- Postoperative Pain
- Being tested
- Ropivacaine 150 mg, saline 15 ml
- Keywords
- Laparoscopic, Colectomy, Nebulization, Ropivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 150 mgDrug
Also called Nebulization Ropivacaine
Nebulization of Ropivacaine 150 mg in the peritoneal cavity
saline 15 mlDrug
Also called Nebulization Saline
Nebulization of saline 15 ml in the peritoneal cavity
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine 150 mg | Experimental | Nebulization of Ropivacaine 150 mg in the peritoneal cavity with the Aeroneb Pro system Receives: Drug: Ropivacaine 150 mg |
| Saline 15 ml | Placebo comparator | Nebulization of Saline 15 ml in the peritoneal cavity with the Aeroneb Pro system Receives: Drug: saline 15 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Numeric Ranking Scale (NRS 0 to 10 points) at rest (static NRS) and after a deep inspiration or cough (dynamic NRS) in PACU and at 6, 24, 48 and 72 hours after the discharge from PACU.
Measured: 72 hours
Secondary outcomes (5)
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: 72 hours
Return to active bowel function
The return of bowel function will be assessed using two parameters: time of first flatus and time of first bowel movement.
Measured: 72 hours
Hospital morbidity
All complications or adverse effects associated or possibly associated with the interventions under study, surgery or anesthesia will be quantified
Measured: 72 hours
Time and condition for hospital discharge
Time in days elapsed between surgery and hospital discharge.
Measured: 72 hours
Analgesic consumption
The total dose of morphine will be quantified using the PACU clinical chart and/or PCA infusers memory display
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: There was insuficient recruitment in two centers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Gerardo Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milano Bicocca, Azienda Ospedaliera di Lecco, Fondazione IRCCS Policlinico San Matteo di Pavia, University of Pavia
- Responsible party
- Principal investigator, Pablo Mauricio Ingelmo M.D., San Gerardo Hospital
- Investigators
- Pablo M Ingelmo, MD, Principal investigator, San Gerardo Hospital, MB, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432496
- Sponsor's protocol ID
- AR HSG 06 2010 Colectomy
- Status last verified
- Feb 2013
- First submitted
- 9 Sep 2011
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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 17180268Greib 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 18633034Schlotterbeck 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric, Randomized, Controlled, Double Blinded, Phase III Clinical Trial; Comparing Peritoneal Nebulization of Ropivacaine 150 mg With Peritoneal Nebulization of Saline
- ClinicalTrials.gov ID
- NCT01432496
- Acronym / sponsor ID
- AR HSG 06 2010 Colectomy
- Conditions
- Postoperative Pain
- Keywords
- Laparoscopic, Colectomy, Nebulization, Ropivacaine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There was insuficient recruitment in two centers
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- San Gerardo HospitalUniversity, hospital or other
- Collaborators
- University of Milano Bicocca, Azienda Ospedaliera di Lecco, Fondazione IRCCS Policlinico San Matteo di Pavia, University of Pavia
- Study start
- Sep 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 150 mg produces better postoperative pain control than Saline nebulization after laparoscopic colectomy.
Detailed description
Recently intraperitoneal nebulization of local anesthetic has been used as an alternative to direct intraperitoneal instillation. Intraperitoneal aerosolization of Bupivacaine 50 mg after laparoscopic cholecystectomy significantly reduced postoperative pain, morphine consumption and incidence of postoperative nausea and vomiting and it is associated with rapid mobilization compared with patients receiving direct instillation of Bupivacaine 50 mg or placebo.
In a recent study the investigators found that nebulization of Ropivacaine 30 mg with the AeronebPro® before or after laparoscopic cholecystectomy and gynecologic laparoscopic surgery reduces postoperative pain and morphine consumption. Patients receiving preoperative nebulization of Ropivacaine presented significantly less postoperative pain (-50% clinical setting) and consumed significant less morphine (-50% and -40% respectively) than patients in control groups during the first 48 hours after surgery.
The effects of peritoneal nebulization of ropivacaine during laparoscopic colectomy on pain control and morphine consumption were not evaluated.
The investigators hypothesize that intraperitoneal nebulization of Ropivacaine may produce better pain control and less morphine consumption than nebulization of saline after laparoscopic colectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine 150 mg | Experimental | Drug: Ropivacaine 150 mgNebulization of Ropivacaine 150 mg in the peritoneal cavity with the Aeroneb Pro system |
| Saline 15 ml | Placebo comparator | Drug: saline 15 mlNebulization of Saline 15 ml in the peritoneal cavity with the Aeroneb Pro system |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Females and Males 18-80 years old
- ASA Score I (American Society of Anesthesiologists classification : a normal healthy patient.
- ASA Score II (American Society of Anesthesiologists classification): A patient with mild systemic disease
- ASA Score III (American Society of Anesthesiologists classification): A patient with severe systemic disease
- Patients scheduled for oncological laparoscopic colectomy
Key exclusion criteria (15 listed)
- Females and Males under 18 or over 80
- ASA Score IV (American Society of Anesthesiologists classification): A patient with severe systemic disease that is a constant threat to life
- ASA Score V (American Society of Anesthesiologists classification): A moribund patient who is not expected to survive without the operation
- Emergency/urgency surgery
- Postoperative admission in an intensive care unit with sedation or ventilatory assistance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine 150 mgAlso: Nebulization RopivacaineNebulization of Ropivacaine 150 mg in the peritoneal cavity | Drug | Ropivacaine 150 mg |
| saline 15 mlAlso: Nebulization SalineNebulization of saline 15 ml in the peritoneal cavity | Drug | Saline 15 ml |
Primary outcome
Postoperative pain
Time frame: 72 hours
Numeric Ranking Scale (NRS 0 to 10 points) at rest (static NRS) and after a deep inspiration or cough (dynamic NRS) in PACU and at 6, 24, 48 and 72 hours after the discharge from PACU.
5 secondary outcomes
Time of unassisted walking
Time frame: 72 hours
Return to active bowel function
Time frame: 72 hours
Hospital morbidity
Time frame: 72 hours
Time and condition for hospital discharge
Time frame: 72 hours
Analgesic consumption
Time frame: 72 hours
Results and safety
The study was stopped early (reason given: There was insuficient recruitment in two centers). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2013.
- Background: PubMed 17180268Alkhamesi 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.
- Background: PubMed 18633034Greib 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.
- Background: PubMed 18347861Schlotterbeck 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo M Ingelmo, MD principal investigator
San Gerardo Hospital, MB, Italy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ropivacaine 150 mg and saline 15 ml in people with Postoperative Pain, run by San Gerardo Hospital at 3 sites 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 15 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: stopped early, as of the sponsor's last update on 25 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: There was insuficient recruitment in two centers). Results are not available in the source record.
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?
Postoperative pain (time frame: 72 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 NCT01432496, 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 25 Feb 2013.