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

December 27, 2013 updated by: Hagar Mizrahi, The Baruch Padeh Medical Center, Poriya
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

90

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
    • The Lower Galilee
      • Poriya, The Lower Galilee, Israel
        • General Surgery Ward

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control
Irrigation will be carried out with saline
Drug: control saline
Surgical bed irrigation with saline 40ml
Other Names:
  • saline
Active Comparator: Lidocaine
Irrigation will be carried out with Lidocaine
Drug: Lidocaine
surgical bed Irrigation Lidocaine 0.5%, 40ml
Active Comparator: Ropivacaine
Irrigation will be carried out with Ropivacaine
Drug: Ropivacaine
surgical bed Irrigation Ropivacaine 0.2%, 40ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 1 year
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
1 year

Collaborators and Investigators

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

Sponsor

The Baruch Padeh Medical Center, Poriya

Investigators

  • Principal Investigator: Hagar Mizrahi, M.D. MSc, The BARUCH PADEH Medical Center, Poriya, ISRAEL

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

January 1, 2014

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

November 8, 2013

First Submitted That Met QC Criteria

December 27, 2013

First Posted (Estimate)

December 30, 2013

Study Record Updates

Last Update Posted (Estimate)

December 30, 2013

Last Update Submitted That Met QC Criteria

December 27, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-2013.CTIL

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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