Evaluation of Local Anlagesia Into the Trocar Site During Operative Laparosocpy

NCT ID: NCT00728559

Last Updated: 2011-02-03

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-09-30

Brief Summary

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In the literature there is conflicting data on administration of local analgesia in addition to the general anesthesia to the trocar sites during laparoscopy, We believe that adding local analgesia to the general anesthesia during laparoscopy is beneficial . the current study will evaluate prospectivly the impact of local analgesia on postoperative pain and recovery in patients undergoing operative laparoscopy

Detailed Description

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Methods: this is a blinded prospective randomized study. After approval of IRB and informed consent 120 patients undergoing for laparoscopy will be randomized after the induction of general anesthesia into three groups: Group A will receive preemptive analgesia using 3-5 cc of 0,5 % marcaine at the beginning of the procedure. Group 2 will receive a local analgesia using 3-5 cc marcaine at the end of the procedure. Group 3 will be operated under general anesthesia only. The post operative pain and patient recovery will be assessed by the nurses during the hospitalization using a VAS (Visual Analog Scale) the total analgetic drugs will be noted and after the patients discharge the patient status and satisfaction will be evaluated by phone up to 2 wks

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

preemptive trocar site analgesia

Group Type EXPERIMENTAL

bupivacain 0.5%

Intervention Type DRUG

trocar site injection

2

trocar site pre skin closure analgesia

Group Type EXPERIMENTAL

bupivacain 0.5%

Intervention Type DRUG

trocar site injection

3

control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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bupivacain 0.5%

trocar site injection

Intervention Type DRUG

Other Intervention Names

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marcaine

Eligibility Criteria

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Inclusion Criteria

* Female older then 18 y/o

Exclusion Criteria

* Allergy to marcaine
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Health, Israel

OTHER_GOV

Sponsor Role collaborator

The Baruch Padeh Medical Center, Poriya

OTHER_GOV

Sponsor Role lead

Responsible Party

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Poria Medical Center

Principal Investigators

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Ilan Atlas, MD

Role: STUDY_CHAIR

Ministry of Health, Israel

Locations

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Poria Gov Hospital

Tiberias, Lower Galilee, Israel

Site Status

Countries

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Israel

Central Contacts

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Ilan atlas, md

Role: CONTACT

011972506267421

samer tannus, md

Role: CONTACT

01197249540410

Facility Contacts

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ilan Atlas, MD

Role: primary

01197249080914

Samer Tannus, MD

Role: backup

01197246652565

Other Identifiers

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lapmar1.CTIL

Identifier Type: -

Identifier Source: org_study_id

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