Effectiveness of Bupivacaine After Laparoscopic Cholecystectomy

NCT ID: NCT00599144

Last Updated: 2008-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-01-31

Brief Summary

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

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

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

Group Type EXPERIMENTAL

videolaparocholecystectomy

Intervention Type PROCEDURE

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

videolaparocholecystectomy

Intervention Type PROCEDURE

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

2

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

Group Type EXPERIMENTAL

videolaparocholecystectomy

Intervention Type PROCEDURE

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

3

Group3: control group without any local anesthetic use.

Group Type NO_INTERVENTION

videolaparocholecystectomy

Intervention Type PROCEDURE

Group3: control group without any local anesthetic use.

Interventions

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videolaparocholecystectomy

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

Intervention Type PROCEDURE

videolaparocholecystectomy

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

Intervention Type PROCEDURE

videolaparocholecystectomy

Group3: control group without any local anesthetic use.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Santa Maria alla Gruccia Hospital

OTHER

Sponsor Role lead

Responsible Party

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Asl 8 santa maria alla gruccia hospital

Principal Investigators

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Marco Scatizzi, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Santa maria alla gruccia

Locations

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Ospedale santa maria alla gruccia

Montevarchi, Ar, Italy

Site Status

Countries

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Italy

References

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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. doi: 10.1007/s00464-005-0284-5. Epub 2006 Aug 1.

Reference Type BACKGROUND
PMID: 16897291 (View on PubMed)

Feroci F, Kroning KC, Moraldi L, Borrelli A, Ottaviano A, De Prizio M, Scatizzi M. [A new effective method to reduce pain after laparoscopic cholecystectomy]. G Chir. 2010 Oct;31(10):423-8. Italian.

Reference Type DERIVED
PMID: 20939947 (View on PubMed)

Feroci F, Kroning KC, Scatizzi M. Effectiveness for pain after laparoscopic cholecystectomy of 0.5% bupivacaine-soaked Tabotamp placed in the gallbladder bed: a prospective, randomized, clinical trial. Surg Endosc. 2009 Oct;23(10):2214-20. doi: 10.1007/s00464-008-0301-6. Epub 2009 Jan 28.

Reference Type DERIVED
PMID: 19184217 (View on PubMed)

Other Identifiers

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usl8

Identifier Type: -

Identifier Source: org_study_id

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