Intraperitoneal Local Anesthetic in Bariatric Surgery Study (iLABS Study)

Summary

Obesity is a metabolic disorder that has gradually become a prevalent public health problem and is becoming one of the leading causes of death and disability worldwide. The most efficacious therapy for morbid obesity today is bariatric surgery. Bariatric surgery increases life expectancy by correcting the comorbidities associated with obesity, improves the quality of life, and is associated with reduced morbidity and mortality. There is an increase application of laparoscopic procedures as it is considered to cause less pain than traditional open surgery, smaller incision, reduced blood loss and shorter postoperative stay, which cuts down on hospital cost. However, postoperative pain still exists causing unpleasant experience for the patient and at times causes a delayed discharge. Pain after bariatric surgery is a result of many mechanisms such as tissue injury, abdominal distention, local trauma of the stomach, chemical irritation of the peritoneum, and the pneumoperitoneum and this pain potentially can prolong hospital stay and lead to increased morbidity, and bariatric surgeons are striving to minimize the morbidity of current procedures to improve patient outcomes and this gave rise to the use of intraperitoneal local anesthetics (LA). It was found that the use of intraperitoneal LA in laparoscopic cholecystectomy is safe, and it results in a statistically significant reduction in early postoperative abdominal pain. Many studies were done to evaluate the efficacy of intraperitoneal LA in laparoscopic cholecystectomy, gynecologic procedures and appendectomy but to date there are limited studies done to evaluate the role of intraperitoneal LA in bariatric surgery. The aim of this study is to evaluate the effectiveness of intraperitoneal instillation of local ropivacaine on postoperative abdominal pain after laparoscopic sleeve gastrectomy (LSG). We hypothesized that the administration of intraperitoneal instillation of local ropivacaine would help reduce postoperative pain.

Conditions

• Overweight and Obesity
• Bariatric Surgery Candidate

Interventions

DRUG

Ropivacaine

Patient undergo elective laparoscopic sleeve gastrectomy will receive 20mL of 150mg ropivacaine (0.75%) diluted in 180mL normal saline to be injected through a catheter along the greater curvature and left subdiaphragmatic region of the stomach at the end of the surgical procedure. After the surgery, the medical doctors or nurses in the ward that is not otherwise involved in this research will assess and record the pain score using visual analog scale (VAS) (0-10). The abdomen and shoulder tip pain intensity will be rated at two, four, six, eight, 24 and 48 hours postoperatively.

DRUG

Normal saline

Patient undergo elective laparoscopic sleeve gastrectomy will receive 200mL normal saline to be injected through a catheter along the greater curvature and left subdiaphragmatic region of the stomach at the end of the surgical procedure. After the surgery, the medical doctors or nurses in the ward that is not otherwise involved in this research will assess and record the pain score using visual analog scale (VAS) (0-10). The abdomen and shoulder tip pain intensity will be rated at two, four, six, eight, 24 and 48 hours postoperatively.

Sponsors & Collaborators

• Dr. Tikfu Gee

  lead OTHER

Principal Investigators

• Lim Shu Yu, MS · Universiti Putra Malaysia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-27

Primary Completion

2018-02-27

Completion

2018-04-27

Countries

• Malaysia

Study Locations