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Evaluation of Local Anlagesia Into the Trocar Site During Operative Laparosocpy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by The Baruch Padeh Medical Center, Poriya.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Ministry of Health, Israel
Information provided by:
The Baruch Padeh Medical Center, Poriya
ClinicalTrials.gov Identifier:
NCT00728559
First received: August 1, 2008
Last updated: February 2, 2011
Last verified: August 2008
History of Changes
  Purpose

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 Intervention
Pain
 Drug: bupivacain 0.5%

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Local Anlagesia Into the Trocar Site During Operative Laparosocpy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Baruch Padeh Medical Center, Poriya:

Primary Outcome Measures:
  • postoperative pain measured by VAS [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • total analgesics required, patient recovery, patient satisfaction [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: September 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
control

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female older then 18 y/o

Exclusion Criteria:

  • Allergy to marcaine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728559

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

Locations
Israel
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
Investigators
Study Chair: Ilan Atlas, MD Ministry of Health, Israel
  More Information

No publications provided

Responsible Party: Ilan Atlas, MD Gynecologic Oncology Director, Poria Medical Center
ClinicalTrials.gov Identifier: NCT00728559     History of Changes
Other Study ID Numbers: lapmar1.CTIL
Study First Received: August 1, 2008
Last Updated: February 2, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by The Baruch Padeh Medical Center, Poriya:
laparoscopy
preemptive
postoperative
 pain
trocar
site

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013