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Evaluation of Local Anlagesia Into the Trocar Site During Operative Laparosocpy

Evaluation of Local Anlagesia Into the Trocar Site During Operative Laparosocpy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00728559
Enrollment
120
Registered
2008-08-06
Start date
2010-09-30
Completion date
2011-09-30
Last updated
2011-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

laparoscopy, preemptive, postoperative, pain, trocar, site

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

Interventions

trocar site injection

Sponsors

Ministry of Health, Israel
CollaboratorOTHER_GOV
The Baruch Padeh Medical Center, Poriya
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Female older then 18 y/o

Exclusion criteria

* Allergy to marcaine

Design outcomes

Primary

MeasureTime frame
postoperative pain measured by VAS2 years

Secondary

MeasureTime frame
total analgesics required, patient recovery, patient satisfaction2 years

Countries

Israel

Contacts

Primary ContactIlan atlas, md
ilanatlas@yahoo.com011972506267421
Backup Contactsamer tannus, md
stannus@bezeqint.net01197249540410

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026