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Effectiveness of Bupivacaine After Laparoscopic Cholecystectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00599144
First Posted: January 23, 2008
Last Update Posted: January 23, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Santa Maria alla Gruccia Hospital
January 10, 2008
January 23, 2008
January 23, 2008
January 2007
January 2008   (Final data collection date for 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 ]
Same as current
No Changes Posted
Use of analgesics, extension of postsurgery hospitalization, post operative nausea and vomiting. [ Time Frame: 6 and 24 hours ]
Same as current
Not Provided
Not Provided
 
Effectiveness of Bupivacaine After Laparoscopic Cholecystectomy
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Postoperative Pain
  • Procedure: videolaparocholecystectomy
    Group1: a bupivacaine 0,5% (2mg/kg) soaked-tabotamp is placed in gallbladder bed after remove of gallbladder
  • Procedure: videolaparocholecystectomy
    Group2: bupivacaine 0,5%(2mg/kg)is infiltrated in trocar incision after their closure.
  • Procedure: videolaparocholecystectomy
    Group3: control group without any local anesthetic use.
  • Experimental: 1
    Group1: a bupivacaine 0,5% (2mg/kg) soaked-tabotamp is placed in gallbladder bed after remove of gallbladder
    Interventions:
    • Procedure: videolaparocholecystectomy
    • Procedure: videolaparocholecystectomy
  • Experimental: 2
    Group2: bupivacaine 0,5%(2mg/kg)is infiltrated in trocar incision after their closure.
    Intervention: Procedure: videolaparocholecystectomy
  • No Intervention: 3
    Group3: control group without any local anesthetic use.
    Intervention: Procedure: videolaparocholecystectomy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
January 2008
January 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00599144
usl8
Yes
Not Provided
Not Provided
Marco Scatizzi MD, Asl 8 santa maria alla gruccia hospital
Santa Maria alla Gruccia Hospital
Not Provided
Principal Investigator: Marco Scatizzi, MD Ospedale Santa maria alla gruccia
Santa Maria alla Gruccia Hospital
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP