Evaluation of Local Anlagesia Into the Trocar Site During Operative Laparosocpy

February 2, 2011 updated by: The Baruch Padeh Medical Center, Poriya
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
    • Lower Galilee
      • Tiberias, Lower Galilee, Israel, 15208
        • Poria Gov Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female older then 18 y/o

Exclusion Criteria:

  • Allergy to marcaine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 3
control
Experimental: 1
preemptive trocar site analgesia
Drug: bupivacain 0.5%
trocar site injection
Other Names:
  • marcaine
Experimental: 2
trocar site pre skin closure analgesia
Drug: bupivacain 0.5%
trocar site injection
Other Names:
  • marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative pain measured by VAS
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
total analgesics required, patient recovery, patient satisfaction
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Baruch Padeh Medical Center, Poriya

Collaborators

Ministry of Health, Israel

Investigators

  • Study Chair: Ilan Atlas, MD, Ministry of Health, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

September 1, 2011

Study Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

August 1, 2008

First Submitted That Met QC Criteria

August 5, 2008

First Posted (Estimate)

August 6, 2008

Study Record Updates

Last Update Posted (Estimate)

February 3, 2011

Last Update Submitted That Met QC Criteria

February 2, 2011

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lapmar1.CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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