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Evaluation of Local Anlagesia Into the Trocar Site During Operative Laparosocpy

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ClinicalTrials.gov Identifier: NCT00728559
Recruitment Status : Unknown
Verified August 2008 by The Baruch Padeh Medical Center, Poriya.
Recruitment status was:  Not yet recruiting
First Posted : August 6, 2008
Last Update Posted : February 3, 2011
Information provided by:

Study Description
Brief Summary:
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

Condition or disease Intervention/treatment
Pain Drug: bupivacain 0.5%

Detailed Description:
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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Local Anlagesia Into the Trocar Site During Operative Laparosocpy
Study Start Date : September 2010
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
preemptive trocar site analgesia
Drug: bupivacain 0.5%
trocar site injection
Other Name: marcaine
Experimental: 2
trocar site pre skin closure analgesia
Drug: bupivacain 0.5%
trocar site injection
Other Name: marcaine
No Intervention: 3

Outcome Measures

Primary Outcome Measures :
  1. postoperative pain measured by VAS [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. total analgesics required, patient recovery, patient satisfaction [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Female older then 18 y/o

Exclusion Criteria:

  • Allergy to marcaine
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00728559

Contact: Ilan atlas, md 011972506267421 ilanatlas@yahoo.com
Contact: samer tannus, md 01197249540410 stannus@bezeqint.net

Poria Gov Hospital Not yet recruiting
Tiberias, Lower Galilee, Israel, 15208
Contact: ilan Atlas, MD    01197249080914    ilanatlas@yahoo.com   
Contact: Samer Tannus, MD    01197246652565    stannus@bezeqint.co.il   
Principal Investigator: Ilan Atlas, MD         
Sponsors and Collaborators
The Baruch Padeh Medical Center, Poriya
Ministry of Health, Israel
Study Chair: Ilan Atlas, MD Ministry of Health, Israel
More Information

Responsible Party: Ilan Atlas, MD Gynecologic Oncology Director, Poria Medical Center
ClinicalTrials.gov Identifier: NCT00728559     History of Changes
Other Study ID Numbers: lapmar1.CTIL
First Posted: August 6, 2008    Key Record Dates
Last Update Posted: February 3, 2011
Last Verified: August 2008

Keywords provided by The Baruch Padeh Medical Center, Poriya:

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents