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

Sponsor

The Baruch Padeh Medical Center, Poriya (Other)

Overall Status

Unknown status

CT.gov ID

NCT02023684

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity	Drug: control saline Drug: Lidocaine Drug: Ropivacaine	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jan 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2014

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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