Evaluation of Local Anlagesia Into the Trocar Site During Operative Laparosocpy

Not Applicable

• Conditions: Pain
• Interventions: Drug: bupivacain 0.5%

• Registration Number: NCT00728559
• Lead Sponsor: The Baruch Padeh Medical Center, Poriya

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

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 Timeline

• Status Verified: 2008-08
• Study First Submitted: 2008-08-01
• Study First Submitted QC: 2008-08-05
• Study First Posted: 2008-08-06
• Study Start: 2010-09
• Last Update Submitted: 2011-02-02
• Last Update Posted: 2011-02-03
• Primary Completion: 2011-09
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Female older then 18 y/o

Exclusion Criteria

• Allergy to marcaine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	bupivacain 0.5%	preemptive trocar site analgesia
2	bupivacain 0.5%	trocar site pre skin closure analgesia

Primary Outcome Measures

Name	Time	Method
postoperative pain measured by VAS	2 years

Secondary Outcome Measures

Name	Time	Method
total analgesics required, patient recovery, patient satisfaction	2 years

Trial Locations

Locations (1)

Poria Gov Hospital; 🇮🇱 Tiberias, Lower Galilee, Israel