NCT00599144

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 23, 2008

Completed
Last Updated

January 23, 2008

Status Verified

January 1, 2008

Enrollment Period

1 year

First QC Date

January 10, 2008

Last Update Submit

January 22, 2008

Conditions

Postoperative Pain

Keywords

Cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Use of analgesics, extension of postsurgery hospitalization, post operative nausea and vomiting.

    6 and 24 hours

Study Arms (3)

1

EXPERIMENTAL

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

Procedure: videolaparocholecystectomy

2

EXPERIMENTAL

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

Procedure: videolaparocholecystectomy

3

NO INTERVENTION

Group3: control group without any local anesthetic use.

Procedure: videolaparocholecystectomy

Interventions

videolaparocholecystectomyPROCEDURE

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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale santa maria alla gruccia

Montevarchi, Ar, 52100, Italy

Location

Related Publications (3)

  • 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.

    PMID: 16897291BACKGROUND

  • 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.

    PMID: 20939947DERIVED

  • 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.

    PMID: 19184217DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Marco Scatizzi, MD

    Ospedale Santa maria alla gruccia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2008

First Posted

January 23, 2008

Study Start

January 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

January 23, 2008

Record last verified: 2008-01

Locations

IT(1)