- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02976571
Local and Intraperitoneal Analgetics in Gynecologic Laparoscopy for Post Operative Pain Relief
May 8, 2018 updated by: Wolfson Medical Center
A comparison between local and intraperitoneal analgetics to placebo, during laparoscopy, regarding post operative pain.
Study Overview
Detailed Description
4 randomly assigned groups.
Grop 1 will get sub cutaneous and intraperitoneal marcain.
Grop 2 will get sub cutaneous marcaine and intraperitoneal saline.
Grop 3 will get sub cutaneus saline and intraperitoneal marcaine.
Grop 4 will get ub cutaneous and intraperitoneal saline
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ohad Gluck, MD
- Phone Number: 97235028329
- Email: ohadgluck@gmail.com
Study Contact Backup
- Name: Elad Barer, MD
- Phone Number: 9725028329
- Email: elad.barber@gmail.com
Study Locations
-
-
-
H̱olon, Israel
- Recruiting
- Wolfson Medical Center
-
Contact:
- Ohad Gluck, MD
- Phone Number: 97235028329
- Email: ohadgluck@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Elective laparoscopy
Exclusion Criteria:
- Laparotomy Vaginal operations Oncologic operations Chronic use of analgetics due to pelvic pain Pregnancy Operations lasts more than 3 hours
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sub cutaneous+Intraperitoneal
Sub cutaneous Bupivacaine+ Intraperitoneal bupivacaine
|
Sub cutaneous and/or Intraperitoneal Marcaine application
Other Names:
|
Active Comparator: Sub cutaneous+Placebo
Sub cutaneous Bupivacaine+ Intraperitoneal Nacl 0.9%
|
Sub cutaneous and/or Intraperitoneal Marcaine application
Other Names:
|
Active Comparator: Placebo+Intraperitoneal
Sub cutaneous Nacl 0.9%+ Intraperitoneal bupivacaine
|
Sub cutaneous and/or Intraperitoneal Marcaine application
Other Names:
|
Placebo Comparator: Placebo+Placebo
Sub cutaneous Nacl 0.9%+ Intraperitoneal Nacl 0.9%
|
Sub cutaneous and/or Intraperitoneal Marcaine application
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain level during movement, 8 hours after laparoscopy
Time Frame: 8 hours
|
8 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ohad Gluck, MD, Wolfson Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2016
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
November 23, 2016
First Submitted That Met QC Criteria
November 28, 2016
First Posted (Estimate)
November 29, 2016
Study Record Updates
Last Update Posted (Actual)
May 9, 2018
Last Update Submitted That Met QC Criteria
May 8, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0198-16-WOMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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