Effectiveness of Bupivacaine After Laparoscopic Cholecystectomy

Santa Maria alla Gruccia Hospital

Status: Completed

Conditions: Postoperative Pain

Treatments: Procedure: videolaparocholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00599144

usl8

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

45 participants in 3 patient groups

1

Experimental group

Description:

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

Treatment:

Procedure: videolaparocholecystectomy

Procedure: videolaparocholecystectomy

Procedure: videolaparocholecystectomy

2

Experimental group

Description:

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

Treatment:

Procedure: videolaparocholecystectomy

Procedure: videolaparocholecystectomy

Procedure: videolaparocholecystectomy

3

No Intervention group

Description:

Group3: control group without any local anesthetic use.

Treatment:

Procedure: videolaparocholecystectomy

Procedure: videolaparocholecystectomy

Procedure: videolaparocholecystectomy