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Evaluation of Local Anlagesia Into the Trocar Site During Operative Laparosocpy

B

Baruch Padeh Medical Center

Status

Unknown

Conditions

Pain

Treatments

Drug: bupivacain 0.5%

Study type

Interventional

Funder types

Other

Identifiers

NCT00728559
lapmar1.CTIL

Details and patient eligibility

About

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

Full 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

Enrollment

120 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Female older then 18 y/o

Exclusion criteria

  • Allergy to marcaine

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

120 participants in 3 patient groups

1
Experimental group
Description:
preemptive trocar site analgesia
Treatment:
Drug: bupivacain 0.5%
2
Experimental group
Description:
trocar site pre skin closure analgesia
Treatment:
Drug: bupivacain 0.5%
3
No Intervention group
Description:
control

Trial contacts and locations

1

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Central trial contact

Ilan atlas, md; samer tannus, md

Data sourced from clinicaltrials.gov

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