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Effectiveness of Bupivacaine After Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT00599144
Recruitment Status : Completed
First Posted : January 23, 2008
Last Update Posted : January 23, 2008
Sponsor:
Information provided by:
Santa Maria alla Gruccia Hospital

Brief Summary:
Evaluate the efficacy on postoperative pain of the positioning of a 0,5% bupivacaine soaked-tabotamp in gallbladder bed after videolaparoscopic cholecystectomy.

Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: videolaparocholecystectomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness for Postoperative Pain After Laparoscopic Cholecystectomy of 0,5% Bupivacaine-Soaked Tabotamp Placed in the Gallbladder Bed
Study Start Date : January 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Group1: a bupivacaine 0,5% (2mg/kg) soaked-tabotamp is placed in gallbladder bed after remove of gallbladder
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.

Experimental: 2
Group2: bupivacaine 0,5%(2mg/kg)is infiltrated in trocar incision after their closure.
Procedure: videolaparocholecystectomy
Group2: bupivacaine 0,5%(2mg/kg)is infiltrated in trocar incision after their closure.

No Intervention: 3
Group3: control group without any local anesthetic use.
Procedure: videolaparocholecystectomy
Group3: control group without any local anesthetic use.




Primary Outcome Measures :
  1. 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 Measures :
  1. Use of analgesics, extension of postsurgery hospitalization, post operative nausea and vomiting. [ Time Frame: 6 and 24 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00599144


Locations
Italy
Ospedale santa maria alla gruccia
Montevarchi, Ar, Italy, 52100
Sponsors and Collaborators
Santa Maria alla Gruccia Hospital
Investigators
Principal Investigator: Marco Scatizzi, MD Ospedale Santa maria alla gruccia

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marco Scatizzi MD, Asl 8 santa maria alla gruccia hospital
ClinicalTrials.gov Identifier: NCT00599144     History of Changes
Other Study ID Numbers: usl8
First Posted: January 23, 2008    Key Record Dates
Last Update Posted: January 23, 2008
Last Verified: January 2008

Keywords provided by Santa Maria alla Gruccia Hospital:
Cholecystectomy

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents