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

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: Overweight and Obesity
• Intervention / Treatment: Drug: control saline; Drug: Lidocaine; Drug: Ropivacaine

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

• Study Contact: Name: Nissim Geron, MD; Phone Number: 972-4-6652667; Email: ngeron@poria.health.gov.il
• Study Contact Backup: Name: Hagar Mizrahi, MD MSc; Phone Number: 972-4-6652667; Email: hmizrahi@poria.health.gov.il

Study Locations

• Israel
  • The Lower Galilee
    • Poriya, The Lower Galilee, Israel
      • General Surgery Ward
      • Contact: Hagar Mizrahi, MD MSc; Phone Number: 972-4-6652667; Email: hmizrahi@poria.health.il
      • Principal Investigator: Hagar Mizrahi, MD MSc

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

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	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

• 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

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: ropivacaine; Lidocaine; Sleeve Gastrectomy
• Additional Relevant MeSH Terms: Body Weight; Overweight; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Ropivacaine
• Other Study ID Numbers: 10-2013.CTIL