Intraperitoneal Ropivacaine Irrigation in Bariatric Surgery

Hospital General Universitario Elche

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Normal saline irrigation; Drug: Ropivacaine irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT02641288

HURJC15-77

Details and patient eligibility

About

A prospective randomized clinical trial of all the patients undergoing laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB) will be performed. Patients will be randomized in 2 groups: those patients undergoing intraperitoneal ropivacaine irrigation (Experimental Group - EG) and those undergoing intraperitoneal irrigation with normal saline (Control Group - CG).

Full description

A prospective randomized clinical trial of all the patients undergoing laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB) will be performed. Patients will be randomized in 2 groups: those patients undergoing intraperitoneal ropivacaine irrigation 300mg in 200 ml(Experimental Group - EG) and those undergoing intraperitoneal irrigation with normal saline 200ml (Control Group - CG).

Enrollment: 110 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) >40 Kg/m2
• BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity.

Exclusion criteria

• patients undergoing other bariatric techniques or revisional surgery
• allergy to local anesthetics
• severe underlying cardiovascular diseases
• chronic renal failure
• hepatic dysfunction
• previous foregut surgery
• patients with any contraindication for bariatric surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups, including a placebo group

Ropivacaine irrigation

Experimental group

Description:

Using a standard irrigation device, 300 mg total of ropivacaine in 200ml normal saline will be instilled into the abdomen after surgical dissection, just before abdominal wall closure. Under direct visualization, the solution is delivered over the oesophageal hiatus, over both anastomoses and in both subdiaphragmatic spaces.

Treatment:

Drug: Ropivacaine irrigation

Normal saline irrigation

Placebo Comparator group

Description:

Using a standard irrigation device, 200ml normal saline will be instilled into the abdomen after surgical dissection, just before abdominal wall closure. Under direct visualization, the solution is delivered over the oesophageal hiatus, over both anastomoses and in both subdiaphragmatic spaces.

Treatment:

Drug: Normal saline irrigation