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

Not Applicable

• Conditions: Overweight and Obesity
• Interventions: Drug: control saline; Drug: Ropivacaine; Drug: Lidocaine

• Registration Number: NCT02023684
• Lead Sponsor: The Baruch Padeh Medical Center, Poriya

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

Study Timeline

• Status Verified: 2013-11
• Study First Submitted: 2013-11-08
• Study First Submitted QC: 2013-12-27
• Last Update Submitted: 2013-12-27
• Study First Posted: 2013-12-30
• Last Update Posted: 2013-12-30
• Study Start: 2014-01
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	control saline	Irrigation will be carried out with saline
Ropivacaine	Ropivacaine	Irrigation will be carried out with Ropivacaine
Lidocaine	Lidocaine	Irrigation will be carried out with Lidocaine

Primary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (1)

General Surgery Ward; 🇮🇱 Poriya, The Lower Galilee, Israel