Effectiveness of Bupivacaine After Laparoscopic Cholecystectomy
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
videolaparocholecystectomy
videolaparocholecystectomy
videolaparocholecystectomy
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Cholecystectomy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Ospedale santa maria alla gruccia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
1
2
3
Arm Description
Group1: a bupivacaine 0,5% (2mg/kg) soaked-tabotamp is placed in gallbladder bed after remove of gallbladder
Group2: bupivacaine 0,5%(2mg/kg)is infiltrated in trocar incision after their closure.
Group3: control group without any local anesthetic use.
Outcomes
Primary Outcome Measures
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],
Secondary Outcome Measures
Use of analgesics, extension of postsurgery hospitalization, post operative nausea and vomiting.
Full Information
NCT ID
NCT00599144
First Posted
January 10, 2008
Last Updated
January 22, 2008
Sponsor
Santa Maria alla Gruccia Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00599144
Brief Title
Effectiveness of Bupivacaine After Laparoscopic Cholecystectomy
Official Title
Effectiveness for Postoperative Pain After Laparoscopic Cholecystectomy of 0,5% Bupivacaine-Soaked Tabotamp Placed in the Gallbladder Bed
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Santa Maria alla Gruccia Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluate the efficacy on postoperative pain of the positioning of a 0,5% bupivacaine soaked-tabotamp in gallbladder bed after videolaparoscopic cholecystectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Cholecystectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Group1: a bupivacaine 0,5% (2mg/kg) soaked-tabotamp is placed in gallbladder bed after remove of gallbladder
Arm Title
2
Arm Type
Experimental
Arm Description
Group2: bupivacaine 0,5%(2mg/kg)is infiltrated in trocar incision after their closure.
Arm Title
3
Arm Type
No Intervention
Arm Description
Group3: control group without any local anesthetic use.
Intervention Type
Procedure
Intervention Name(s)
videolaparocholecystectomy
Intervention Description
Group1: a bupivacaine 0,5% (2mg/kg) soaked-tabotamp is placed in gallbladder bed after remove of gallbladder
Intervention Type
Procedure
Intervention Name(s)
videolaparocholecystectomy
Intervention Description
Group2: bupivacaine 0,5%(2mg/kg)is infiltrated in trocar incision after their closure.
Intervention Type
Procedure
Intervention Name(s)
videolaparocholecystectomy
Intervention Description
Group3: control group without any local anesthetic use.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Use of analgesics, extension of postsurgery hospitalization, post operative nausea and vomiting.
Time Frame
6 and 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Scatizzi, MD
Organizational Affiliation
Ospedale Santa maria alla gruccia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale santa maria alla gruccia
City
Montevarchi
State/Province
Ar
ZIP/Postal Code
52100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
16897291
Citation
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.
Results Reference
background
PubMed Identifier
20939947
Citation
Feroci 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.
Results Reference
derived
PubMed Identifier
19184217
Citation
Feroci 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.
Results Reference
derived
Learn more about this trial
Effectiveness of Bupivacaine After Laparoscopic Cholecystectomy
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