Intraperitoneal Ropivacaine Irrigation in Bariatric Surgery

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).

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ropivacaine irrigation

Drug

Using a standard irrigation device (no specific device is being used), 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.

Other names: Intraperitoneal Ropivacaine irrigation

Normal saline irrigation

Drug

Using a standard irrigation device (no specific device is being used), 200ml normal saline will be instilled into the abdomen after surgical dissection, just before abdominal wall closure.

Other names: Intraperitoneal Normal saline irrigation

Primary outcomes

Pain

Time frame: 24 hours postoperatively

Postoperative pain will be evaluated by a blinded nurse 24 hours after surgery. Pain will be quantified using a visual analogic scale (VAS), ranging from 0(absence of pain) to 10 (unbearable pain).

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Elche

Other

Registry information

Official study title

Intraperitoneal Ropivacaine Irrigation in Patients Undergoing Bariatric Surgery

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Dec 29, 2015
Registry last updated: Dec 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed