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Effectiveness of Bupivacaine After Laparoscopic Cholecystectomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00599144
Enrollment
45
Registered
2008-01-23
Start date
2007-01-31
Completion date
2008-01-31
Last updated
2008-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

Cholecystectomy

Brief summary

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

Interventions

PROCEDUREvideolaparocholecystectomy

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

Sponsors

Santa Maria alla Gruccia Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
Use of analgesics, extension of postsurgery hospitalization, post operative nausea and vomiting.6 and 24 hours

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026