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

NCT ID: NCT02023684

Last Updated: 2013-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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

Conditions

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Overweight and Obesity

Keywords

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Sleeve Gastrectomy Lidocaine ropivacaine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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control

Irrigation will be carried out with saline

Group Type PLACEBO_COMPARATOR

control saline

Intervention Type DRUG

Surgical bed irrigation with saline 40ml

Lidocaine

Irrigation will be carried out with Lidocaine

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

surgical bed Irrigation Lidocaine 0.5%, 40ml

Ropivacaine

Irrigation will be carried out with Ropivacaine

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

surgical bed Irrigation Ropivacaine 0.2%, 40ml

Interventions

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control saline

Surgical bed irrigation with saline 40ml

Intervention Type DRUG

Lidocaine

surgical bed Irrigation Lidocaine 0.5%, 40ml

Intervention Type DRUG

Ropivacaine

surgical bed Irrigation Ropivacaine 0.2%, 40ml

Intervention Type DRUG

Other Intervention Names

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saline

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Baruch Padeh Medical Center, Poriya

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hagar Mizrahi

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hagar Mizrahi, M.D. MSc

Role: PRINCIPAL_INVESTIGATOR

The BARUCH PADEH Medical Center, Poriya, ISRAEL

Locations

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General Surgery Ward

Poria – Neve Oved, The Lower Galilee, Israel

Site Status

Countries

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Israel

Central Contacts

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Nissim Geron, MD

Role: CONTACT

Phone: 972-4-6652667

Email: [email protected]

Hagar Mizrahi, MD MSc

Role: CONTACT

Phone: 972-4-6652667

Email: [email protected]

Facility Contacts

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Hagar Mizrahi, MD MSc

Role: primary

Other Identifiers

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10-2013.CTIL

Identifier Type: -

Identifier Source: org_study_id