Effectiveness of Bupivacaine After Laparoscopic Cholecystectomy

This study has been completed.
Sponsor:
Information provided by:
Santa Maria alla Gruccia Hospital
ClinicalTrials.gov Identifier:
NCT00599144
First received: January 10, 2008
Last updated: January 22, 2008
Last verified: January 2008

January 10, 2008
January 22, 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00599144 on ClinicalTrials.gov Archive Site
Use of analgesics, extension of postsurgery hospitalization, post operative nausea and vomiting. [ Time Frame: 6 and 24 hours ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00599144
usl8
Yes
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