The Efficacy of Surgical Site Treatment With Ropivacaine in Laparoscopic Surgery

July 5, 2016 updated by: Farraj Moaad, Western Galilee Hospital-Nahariya

Local Analgesia in Laparoscopic Surgery

Using local analgesia in laparoscopic surgery in order to reduce pain and to reduce the use of narcotic drugs.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

At the end of laparoscopic surgery the investigators will spray ropivacaine in the surgical site; and later the investigators will monitor pain intensity and use of analgesic drugs

Study Type

Interventional

Enrollment (Anticipated)

100

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 Locations

  • Israel
      • Naharia, Israel
        • Naharia Medical Center

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Laparoscopic bariatric surgery
  • Laparoscopic inguinal hernia surgery

Exclusion Criteria:

  • Cardiac arrythmias
  • Active ischemic heart disease
  • pregnancy

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Ropivacaine
Topical use of Ropivacaine
Drug: Topical use
Topical use of Ropivacaine in laparoscopic surgery
Other Names:
  • Placebo
  • Ropivacaine
Other: laparoscopic repair of inguinal hernia
intra-operative treatment with ropivacaine Vs placebo in laparoscopic repair of inguinal hernia
Other: laparoscopic bariatric surgery
intra-operative treatment with ropivacaine Vs placebo in laparoscopic bariatric surgery
Placebo Comparator: Placebo
Topical use of placebo
Drug: Topical use
Topical use of Ropivacaine in laparoscopic surgery
Other Names:
  • Placebo
  • Ropivacaine
Other: laparoscopic repair of inguinal hernia
intra-operative treatment with ropivacaine Vs placebo in laparoscopic repair of inguinal hernia
Other: laparoscopic bariatric surgery
intra-operative treatment with ropivacaine Vs placebo in laparoscopic bariatric surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scale as measured by pain scale questionnaire
Time Frame: 1 Week
post operative pain intensity will be assisted by VAS(visual analog pain scale) scale at fixed times after surgery
1 Week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reducing use of narcotics according to nurse records
Time Frame: 1 Week
patients will be treated by standard analgetic protocol, the records of analgetic drugs will be collected during patients hospitalization
1 Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western Galilee Hospital-Nahariya

Investigators

  • Principal Investigator: Moaad H Farraj, Dr, Galilee Medical Center

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

July 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

June 22, 2016

First Submitted That Met QC Criteria

July 5, 2016

First Posted (Estimate)

July 11, 2016

Study Record Updates

Last Update Posted (Estimate)

July 11, 2016

Last Update Submitted That Met QC Criteria

July 5, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0196-15-NHR

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.

Clinical Trials on Pain

Clinical Trials on Topical use

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe