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

Baruch Padeh Medical Center

Status: Unknown

Conditions: Overweight and Obesity

Treatments: Drug: control saline; Drug: Lidocaine; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02023684

10-2013.CTIL

Details and patient eligibility

About

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.

Full 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

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

90 participants in 3 patient groups, including a placebo group

control

Placebo Comparator group

Description:

Irrigation will be carried out with saline

Treatment:

Drug: control saline

Lidocaine

Active Comparator group

Description:

Irrigation will be carried out with Lidocaine

Treatment:

Drug: Lidocaine

Ropivacaine

Active Comparator group

Description:

Irrigation will be carried out with Ropivacaine

Treatment:

Drug: Ropivacaine