Postoperative PainNCT00599144
Effectiveness of Bupivacaine After Laparoscopic Cholecystectomy
A study testing videolaparocholecystectomy in people with Postoperative Pain, run by Santa Maria alla Gruccia Hospital at 1 site in Italy.
Trial summary
Evaluate the efficacy on postoperative pain of the positioning of a 0,5% bupivacaine soaked-tabotamp in gallbladder bed after videolaparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- videolaparocholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2007to Jan 2008
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years old, ASA 1 and 2
- Gallbladder adenomatous polyposis and cholelithiasis with no byochemical, clinical and instrumental evidence of acute cholecystitis at the moment of surgery.
Who cannot join
- Age<18 years old
- Pregnancy
- Previous major surgery of the supramesocholic compartment
- Acute cholecystitis
- Choledocolitiasis
- Acute pancreatitis at the moment of surgery
- Laparotomic conversion during surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness for Postoperative Pain After Laparoscopic Cholecystectomy of 0,5% Bupivacaine-Soaked Tabotamp Placed in the Gallbladder Bed
Evaluate the efficacy on postoperative pain of the positioning of a 0,5% bupivacaine soaked-tabotamp in gallbladder bed after videolaparoscopic cholecystectomy.
- Conditions
- Postoperative Pain
- Being tested
- videolaparocholecystectomy
- Keywords
- Cholecystectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
videolaparocholecystectomyProcedure or surgery
Group1: a bupivacaine 0,5% (2mg/kg) soaked-tabotamp is placed in gallbladder bed after remove of gallbladder
videolaparocholecystectomyProcedure or surgery
Group2: bupivacaine 0,5%(2mg/kg)is infiltrated in trocar incision after their closure.
videolaparocholecystectomyProcedure or surgery
Group3: control group without any local anesthetic use.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Group1: a bupivacaine 0,5% (2mg/kg) soaked-tabotamp is placed in gallbladder bed after remove of gallbladder Receives: Procedure: videolaparocholecystectomy |
| 2 | Experimental | Group2: bupivacaine 0,5%(2mg/kg)is infiltrated in trocar incision after their closure. Receives: Procedure: videolaparocholecystectomy |
| 3 | No intervention | Group3: control group without any local anesthetic use. Receives: Procedure: videolaparocholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at 6 and 24 hours after surgery measured using the Visual Analogue Scale [VAS] [score 0 to 10, 0 = no pain, 10 = unbearable pain],
Measured: 6 and 24 hours after surgery
Secondary outcomes (1)
Use of analgesics, extension of postsurgery hospitalization, post operative nausea and vomiting.
Measured: 6 and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2008 (estimated)
- Study startJan 2007
- Primary completionJan 2008
- Study completionJan 2008
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santa Maria alla Gruccia Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Marco Scatizzi, MD, Principal investigator, Ospedale Santa maria alla gruccia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599144
- Sponsor's protocol ID
- usl8
- Status last verified
- Jan 2008
- First submitted
- 10 Jan 2008
- Last updated
- 23 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Verma GR, Lyngdoh TS, Kaman L, Bala I. Placement of 0.5% bupivacaine-soaked Surgicel in the gallbladder bed is effective for pain after laparoscopic cholecystectomy. Surg Endosc. 2006 Oct;20(10):1560-4. doi: 10.1007/s00464-005-0284-5. Epub 2006 Aug 1.
PubMed 16897291Feroci F, Kroning KC, Moraldi L, Borrelli A, Ottaviano A, De Prizio M, Scatizzi M. [A new effective method to reduce pain after laparoscopic cholecystectomy]. G Chir. 2010 Oct;31(10):423-8. Italian.
PubMed 20939947Feroci F, Kroning KC, Scatizzi M. Effectiveness for pain after laparoscopic cholecystectomy of 0.5% bupivacaine-soaked Tabotamp placed in the gallbladder bed: a prospective, randomized, clinical trial. Surg Endosc. 2009 Oct;23(10):2214-20. doi: 10.1007/s00464-008-0301-6. Epub 2009 Jan 28.
PubMed 19184217
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness for Postoperative Pain After Laparoscopic Cholecystectomy of 0,5% Bupivacaine-Soaked Tabotamp Placed in the Gallbladder Bed
- ClinicalTrials.gov ID
- NCT00599144
- Acronym / sponsor ID
- usl8
- Conditions
- Postoperative Pain
- Keywords
- Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Santa Maria alla Gruccia HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 23 Jan 2008 (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.
Evaluate the efficacy on postoperative pain of the positioning of a 0,5% bupivacaine soaked-tabotamp in gallbladder bed after videolaparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: videolaparocholecystectomyGroup1: a bupivacaine 0,5% (2mg/kg) soaked-tabotamp is placed in gallbladder bed after remove of gallbladder |
| 2 | Experimental | Procedure: videolaparocholecystectomyGroup2: bupivacaine 0,5%(2mg/kg)is infiltrated in trocar incision after their closure. |
| 3 | No intervention | Procedure: videolaparocholecystectomyGroup3: control group without any local anesthetic use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age>18 years old, ASA 1 and 2
- Gallbladder adenomatous polyposis and cholelithiasis with no byochemical, clinical and instrumental evidence of acute cholecystitis at the moment of surgery.
Key exclusion criteria (7 listed)
- Age<18 years old
- Pregnancy
- Previous major surgery of the supramesocholic compartment
- Acute cholecystitis
- Choledocolitiasis
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 |
|---|---|---|
| videolaparocholecystectomyGroup1: a bupivacaine 0,5% (2mg/kg) soaked-tabotamp is placed in gallbladder bed after remove of gallbladder | Procedure or surgery | 1 |
| videolaparocholecystectomyGroup2: bupivacaine 0,5%(2mg/kg)is infiltrated in trocar incision after their closure. | Procedure or surgery | 1, 2 |
| videolaparocholecystectomyGroup3: control group without any local anesthetic use. | Procedure or surgery | 3 |
Primary outcome
Pain at 6 and 24 hours after surgery measured using the Visual Analogue Scale [VAS] [score 0 to 10, 0 = no pain, 10 = unbearable pain],
Time frame: 6 and 24 hours after surgery
1 secondary outcome
Use of analgesics, extension of postsurgery hospitalization, post operative nausea and vomiting.
Time frame: 6 and 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2008.
- Background: PubMed 16897291Verma GR, Lyngdoh TS, Kaman L, Bala I. Placement of 0.5% bupivacaine-soaked Surgicel in the gallbladder bed is effective for pain after laparoscopic cholecystectomy. Surg Endosc. 2006 Oct;20(10):1560-4. doi: 10.1007/s00464-005-0284-5. Epub 2006 Aug 1.
- Derived from this study: PubMed 20939947Feroci F, Kroning KC, Moraldi L, Borrelli A, Ottaviano A, De Prizio M, Scatizzi M. [A new effective method to reduce pain after laparoscopic cholecystectomy]. G Chir. 2010 Oct;31(10):423-8. Italian.
- Derived from this study: PubMed 19184217Feroci F, Kroning KC, Scatizzi M. Effectiveness for pain after laparoscopic cholecystectomy of 0.5% bupivacaine-soaked Tabotamp placed in the gallbladder bed: a prospective, randomized, clinical trial. Surg Endosc. 2009 Oct;23(10):2214-20. doi: 10.1007/s00464-008-0301-6. Epub 2009 Jan 28.
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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.
Marco Scatizzi, MD principal investigator
Ospedale Santa maria alla gruccia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing videolaparocholecystectomy in people with Postoperative Pain, run by Santa Maria alla Gruccia 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 2 inclusion and 7 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 23 Jan 2008. 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.
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?
Pain at 6 and 24 hours after surgery measured using the Visual Analogue Scale [VAS] [score 0 to 10, 0 = no pain, 10 = unbearable pain], (time frame: 6 and 24 hours after surgery). 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 NCT00599144, 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 23 Jan 2008.