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

NCT02023684 | Unknown DMC

• 1 other identifier: 10-2013.CTIL
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

Sleeve Gastrectomy; Lidocaine; ropivacaine

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Study Arms (3)

control

PLACEBO COMPARATOR

Irrigation will be carried out with saline

Drug: control saline

Lidocaine

ACTIVE COMPARATOR

Irrigation will be carried out with Lidocaine

Drug: Lidocaine

Ropivacaine

ACTIVE COMPARATOR

Irrigation will be carried out with Ropivacaine

Drug: Ropivacaine

Interventions

control saline DRUG

Surgical bed irrigation with saline 40ml

Also known as: saline

control

Lidocaine DRUG

surgical bed Irrigation Lidocaine 0.5%, 40ml

Lidocaine

Ropivacaine DRUG

surgical bed Irrigation Ropivacaine 0.2%, 40ml

Ropivacaine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient admitted to sleeve gastrectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• The Baruch Padeh Medical Center, Poriya: lead

Study Sites (1)

General Surgery Ward

Poria – Neve Oved, The Lower Galilee, Israel

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Sodium Chloride; Lidocaine; Ropivacaine

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Hagar Mizrahi, M.D. MSc

  The BARUCH PADEH Medical Center, Poriya, ISRAEL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nissim Geron, MD

CONTACT

972-4-6652667; ngeron@poria.health.gov.il

Hagar Mizrahi, MD MSc

CONTACT

972-4-6652667; hmizrahi@poria.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: December 30, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 30, 2013

Record last verified: 2013-11

Locations

IL (1)