Effectiveness of Bupivacaine After Laparoscopic Cholecystectomy - Full Text View

Sponsored by:	Santa Maria alla Gruccia Hospital
Information provided by:	Santa Maria alla Gruccia Hospital
ClinicalTrials.gov Identifier:	NCT00599144

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

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Bupivacaine Bupivacaine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effectiveness for Postoperative Pain After Laparoscopic Cholecystectomy of 0,5% Bupivacaine-Soaked Tabotamp Placed in the Gallbladder Bed

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
1: Experimental 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.
2: Experimental 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.
3: No Intervention 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599144

Locations

Italy, Ar
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:

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. Epub 2006 Aug 1.

Responsible Party:	Asl 8 santa maria alla gruccia hospital ( Marco Scatizzi MD )
Study ID Numbers:	usl8
Study First Received:	January 10, 2008
Last Updated:	January 22, 2008
ClinicalTrials.gov Identifier:	NCT00599144
Health Authority:	Italy: Ethics Committee

Keywords provided by Santa Maria alla Gruccia Hospital:

Cholecystectomy

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Bupivacaine
Pain
Pain, Postoperative

Additional relevant MeSH terms:

Pathologic Processes
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants

Anesthetics
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on January 14, 2009