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
  Purpose

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


Condition Intervention
Postoperative Pain
Procedure: videolaparocholecystectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Santa Maria alla Gruccia Hospital:

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], [ Time Frame: 6 and 24 hours after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Use of analgesics, extension of postsurgery hospitalization, post operative nausea and vomiting. [ Time Frame: 6 and 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: January 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Additional 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
Study First Received: January 10, 2008
Last Updated: January 22, 2008
Health Authority: Italy: Ethics Committee

Keywords provided by Santa Maria alla Gruccia Hospital:
Cholecystectomy

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

ClinicalTrials.gov processed this record on October 23, 2014