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Routine Irrigation With Ropivacaine vs. Lidocaine vs. Saline of Surgical Bed in Sleeve Gastrectomy

Primary Purpose

Overweight and Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
control saline
Lidocaine
Ropivacaine
Sponsored by
The Baruch Padeh Medical Center, Poriya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Overweight and Obesity focused on measuring Sleeve Gastrectomy, Lidocaine, ropivacaine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient admitted to sleeve gastrectomy

Exclusion Criteria:

  • Second bariatric procedure Patients younger than 18 years Patients who have drug allergy to Lidocaine or Ropivacain Patients who suffer a cardiac arrhythmia Pregnant patients Mentally challenged patients Patients who refuse to participate in the study

Sites / Locations

  • General Surgery Ward

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

control

Lidocaine

Ropivacaine

Arm Description

Irrigation will be carried out with saline

Irrigation will be carried out with Lidocaine

Irrigation will be carried out with Ropivacaine

Outcomes

Primary Outcome Measures

The aim of the study is to evaluate the effect of local irrigation with ropivacaine vs. Lidocaine vs. Saline of surgical bed in sleeve gastrectomy on post operative pain
measuring the score of pain using visual analog score for pain during the post-operative timemeasuring the number of times pain-control durg were given during the post-operate time

Secondary Outcome Measures

Full Information

First Posted
November 8, 2013
Last Updated
December 27, 2013
Sponsor
The Baruch Padeh Medical Center, Poriya
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1. Study Identification

Unique Protocol Identification Number
NCT02023684
Brief Title
Routine Irrigation With Ropivacaine vs. Lidocaine vs. Saline of Surgical Bed in Sleeve Gastrectomy
Official Title
Routine Irrigation With Ropivacaine vs. Lidocaine vs. Saline of Surgical Bed in Sleeve Gastrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Baruch Padeh Medical Center, Poriya

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to evaluate the effect of ropivacaine and lidocaine irrigation at the surgical bed on postoperative pain relief and breathing parameters in laparoscopic sleeve gastrectomy.
Detailed Description
As in any other surgery, postoperative pain control after bariatric procedure should provide comfort and early mobilisation as well as enable adequate respiratory effort. Early ambulation is thought to reduce the risk of pressure ulcers, deep vein thrombosis and respiratory complications. In contrast, early inadequate postoperative pain management can lead to hypoxemia, hypercarbia and atelectasis. However, the use of opioids for pain control is limited in bariatric surgery due to sedative effect which might worsen obstructive sleep apnoea (OSA), a common comorbidity amongst morbidly obese patients and opioid-sparing techniques might help avoid respiratory complications. Methods of regional analgesic are limited and might be challenging in the obese patient and although techniques such continuous epidural analgesia is possible it is not the common practise. The use of patient-controlled i.v. analgesia of opioids is limited owed to increased risk for hypoxemia and other practises such as routine local anaesthetic port site wound infiltration and systemic non-steroidal drugs are warranted. The benefit of intra-peritoneal irrigation with local anaesthetic for abdominal pain relief after laparoscopic procedures was established in few studies. The aim of this study is to evaluate the effect its' effect on postoperative pain relief and breathing parameters in laparoscopic sleeve gastrectomy.By pain score

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Sleeve Gastrectomy, Lidocaine, ropivacaine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Placebo Comparator
Arm Description
Irrigation will be carried out with saline
Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
Irrigation will be carried out with Lidocaine
Arm Title
Ropivacaine
Arm Type
Active Comparator
Arm Description
Irrigation will be carried out with Ropivacaine
Intervention Type
Drug
Intervention Name(s)
control saline
Other Intervention Name(s)
saline
Intervention Description
Surgical bed irrigation with saline 40ml
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
surgical bed Irrigation Lidocaine 0.5%, 40ml
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
surgical bed Irrigation Ropivacaine 0.2%, 40ml
Primary Outcome Measure Information:
Title
The aim of the study is to evaluate the effect of local irrigation with ropivacaine vs. Lidocaine vs. Saline of surgical bed in sleeve gastrectomy on post operative pain
Description
measuring the score of pain using visual analog score for pain during the post-operative timemeasuring the number of times pain-control durg were given during the post-operate time
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient admitted to sleeve gastrectomy Exclusion Criteria: Second bariatric procedure Patients younger than 18 years Patients who have drug allergy to Lidocaine or Ropivacain Patients who suffer a cardiac arrhythmia Pregnant patients Mentally challenged patients Patients who refuse to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nissim Geron, MD
Phone
972-4-6652667
Email
ngeron@poria.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Hagar Mizrahi, MD MSc
Phone
972-4-6652667
Email
hmizrahi@poria.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hagar Mizrahi, M.D. MSc
Organizational Affiliation
The BARUCH PADEH Medical Center, Poriya, ISRAEL
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Surgery Ward
City
Poriya
State/Province
The Lower Galilee
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hagar Mizrahi, MD MSc
Phone
972-4-6652667
Email
hmizrahi@poria.health.il
First Name & Middle Initial & Last Name & Degree
Hagar Mizrahi, MD MSc

12. IPD Sharing Statement

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Routine Irrigation With Ropivacaine vs. Lidocaine vs. Saline of Surgical Bed in Sleeve Gastrectomy

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