Evaluation of Local Anlagesia Into the Trocar Site During Operative Laparosocpy

Pain Clinical Trial

Official title:

Evaluation of Local Anlagesia Into the Trocar Site During Operative Laparosocpy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00728559
• Other study ID #: lapmar1.CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: August 1, 2008
• Last updated: February 2, 2011
• Start date: September 2010
• Est. completion date: September 2011

Study information

• Verified date: August 2008
• Source: The Baruch Padeh Medical Center, Poriya
• Contact: Ilan atlas, md
• Phone: 011972506267421
• Email: ilanatlas[@]yahoo.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female older then 18 y/o

Exclusion Criteria:

• Allergy to marcaine

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• bupivacain 0.5%
trocar site injection

Locations

Country	Name	City	State
Israel	Poria Gov Hospital	Tiberias	Lower Galilee

Sponsors (2)

Lead Sponsor	Collaborator
The Baruch Padeh Medical Center, Poriya	Ministry of Health, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain measured by VAS		2 years	Yes
Secondary	total analgesics required, patient recovery, patient satisfaction		2 years	Yes