NCT00728559

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2008

Completed
2.1 years until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

February 3, 2011

Status Verified

August 1, 2008

Enrollment Period

1 year

First QC Date

August 1, 2008

Last Update Submit

February 2, 2011

Conditions

Pain

Keywords

laparoscopypreemptivepostoperativepaintrocarsite

Outcome Measures

Primary Outcomes (1)

  • postoperative pain measured by VAS

    2 years

Secondary Outcomes (1)

  • total analgesics required, patient recovery, patient satisfaction

    2 years

Study Arms (3)

1

EXPERIMENTAL

preemptive trocar site analgesia

Drug: bupivacain 0.5%

2

EXPERIMENTAL

trocar site pre skin closure analgesia

Drug: bupivacain 0.5%

3

NO INTERVENTION

control

Interventions

bupivacain 0.5%DRUG

trocar site injection

Also known as: marcaine
12

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female older then 18 y/o

You may not qualify if:

  • Allergy to marcaine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poria Gov Hospital

Tiberias, Lower Galilee, 15208, Israel

Location

MeSH Terms

Conditions

Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Ilan Atlas, MD

    Ministry of Health, Israel

    STUDY CHAIR

Central Study Contacts

Ilan atlas, md

CONTACT

011972506267421ilanatlas@yahoo.com

samer tannus, md

CONTACT

01197249540410stannus@bezeqint.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 1, 2008

First Posted

August 6, 2008

Study Start

September 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

February 3, 2011

Record last verified: 2008-08

Locations

IL(1)