Effectiveness of Bupivacaine After Laparoscopic Cholecystectomy

Postoperative Pain Clinical Trial

Official title:

Effectiveness for Postoperative Pain After Laparoscopic Cholecystectomy of 0,5% Bupivacaine-Soaked Tabotamp Placed in the Gallbladder Bed

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599144
• Other study ID #: usl8
• Status: Completed
• Phase: N/A
• First received: January 10, 2008
• Last updated: January 22, 2008
• Start date: January 2007
• Est. completion date: January 2008

Study information

• Verified date: January 2008
• Source: Santa Maria alla Gruccia Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• videolaparocholecystectomy
Group1: a bupivacaine 0,5% (2mg/kg) soaked-tabotamp is placed in gallbladder bed after remove of gallbladder
• videolaparocholecystectomy
Group2: bupivacaine 0,5%(2mg/kg)is infiltrated in trocar incision after their closure.
• videolaparocholecystectomy
Group3: control group without any local anesthetic use.

Locations

Country	Name	City	State
Italy	Ospedale santa maria alla gruccia	Montevarchi	Ar

Sponsors (1)

Lead Sponsor	Collaborator
Santa Maria alla Gruccia Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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],		6 and 24 hours after surgery	Yes
Secondary	Use of analgesics, extension of postsurgery hospitalization, post operative nausea and vomiting.		6 and 24 hours	Yes