Efficacy of CPPLAI in Laparoscopic Sleeve Gastrectomy Patients
- Conditions
- Obesity, MorbidPain, Postoperative
- Interventions
- Registration Number
- NCT04680923
- Lead Sponsor
- King Khalid University Hospital
- Brief Summary
The high demand for bariatric surgery due to the increasing prevalence of obesity worldwide necessitate evidence-based clinical pathway such as Enhanced Recovery After Bariatric Surgery (ERABS). The paradigm of surgery has been shifted from open to laparoscopic in morbidly obese patients. Laparoscopic Sleeve Gastrectomy (LSG) is the most common procedure performed in our institute for sustained weight loss and amelioration of obesity-related comorbidities. Pain control in ERABS is one of the key factors for improved outcomes. Surgery induced acute postoperative pain, stress response and fatigue lead to prolonged convalescence and hospital stay. Optimal titrated safe postoperative pain management in LSG patients still remains a challenge.
- Detailed Description
Obesity is a complex multifactorial disease. The worldwide prevalence of obesity has doubled since 1980 to a level that now almost a third of the world's population is classified as overweight. Laparoscopic Sleeve Gastrectomy (LSG) is one of the effective treatments for sustained weight loss and to ameliorate the obesity-related comorbidities, and now the most commonly performed bariatric surgery worldwide. Postoperative pain from the laparoscopic portal sites and the visceral pain after gastrectomy requires a multimodal approach for pain management. As obese patients are sensitive to opioids overdose and at risk of respiratory depression and obstructive sleep apnoea, local anesthetic infiltration at the surgical incision sites and preperitoneal can decrease postoperative opioid consumption after LSG. Perioperative multimodal analgesia uses combinations of analgesic medications that act on different sites and pathways in an additive or synergistic manner to achieve pain relief with minimal or no opiate consumption. Although all medications have side effects, opiates have particularly concerning, multisystemic, long-term, and short-term side effects, which increase morbidity and prolong admissions. local infiltration analgesia (LIA) used widely as an effective component of multimodal analgesia and represents valuable options for controlling perioperative pain. LIA involves the injection and/or infusion of a local anesthetic near the site of surgical incision to provide targeted analgesia. A wide variety of techniques have been described, including single-injection intraoperative wound infiltration, indwelling wound infusion catheters, and the recent high-volume LIA technique associated with joint replacement surgery. Although, preperitoneal local anesthetic infiltration is a novel technique that was first described for pain relief after laparoscopic hernia repair. Recently, the investigators have used this technique in our institute during laparoscopic hernia repair which is now gaining popularity worldwide. Another investigator reported that continuous preperitoneal analgesia better attenuated postoperative inflammatory response and provided comparable overall analgesia to that with continuous epidural analgesia following radical cystectomy. Recently, a large systematic review and meta-analysis comparing preperitoneal or subcutaneous wound catheters with epidural analgesia in abdominal surgery showed preperitoneal wound catheters are an effective pain modality in abdominal surgery. Pain control was as effective as epidural analgesia and recovery parameters, opioid consumption, the incidence of hypotension, and patient satisfaction seemed to be in favor of preperitoneal wound catheters compared with active alternatives, as well as placebo. The trend for bariatric surgery is now moving towards opiates-almost free anesthesia. Since the first description of preperitoneal local anesthetic infiltration almost 2 decades ago little work has been done to test its efficacy, especially in LSG patients. The investigators of this study hypothesis that CPPLAI is an effective technique to reduce postoperative pain and favors early mobilization and patient satisfaction due to its fewer side effects.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- American Society of Anesthesiologist (ASA) physical status I-III
- Age 18-60 years
- Either gender
- Obese patients (BMI >35 for laparoscopic sleeve gastrectomy
- American Society of Anesthesiologist (ASA) physical status IV
- Patients uncontrolled HTN
- Anticipated difficult intubation
- Allergic to morphine
- Clinically significant neurological, cardiovascular, renal hepatic disease planned for postoperative surgical intensive care (SICU) admission
- History of drug abuse or chronic opioid use
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CPPLAI CPPLAI Group-1 (CPPLAI) (n= 59) will receive intraoperative combined periportal and preperitoneal bupivacaine 0.25% 2-3 mg/kg diluted in 40 ml normal saline in patients scheduled for laparoscopic sleeve gastrectomy. CPPLAI Bupivacaine 0.25% Group-1 (CPPLAI) (n= 59) will receive intraoperative combined periportal and preperitoneal bupivacaine 0.25% 2-3 mg/kg diluted in 40 ml normal saline in patients scheduled for laparoscopic sleeve gastrectomy. Placebo Placebo Group 2 (placebo) (n= 58) will receive intraoperative combined periportal and preperitoneal sterile water 40 ml in patients scheduled for laparoscopic sleeve gastrectomy.
- Primary Outcome Measures
Name Time Method Postoperative pain From preoperative to day two postoperative Pain will be measured postoperatively using numerical rating scale (NRS) from 0 to 10 after laparoscopic sleeve gastrectomy. Where 0 is no pain and 10 is worst pain imaginable.
- Secondary Outcome Measures
Name Time Method Postoperative Morphine consumption From preoperative to day two postoperative Postoperative intravenous Morphine consumption in milligrams will be calculated as a total dose per patient that received to control pain after laparoscopic sleeve gastrectomy.
Length of hospital stay Through study completion, an average of 2 days. Total number of days the patient stay in the hospital
Trial Locations
- Locations (1)
King Khalid University Hospital
🇸🇦Riyadh, Saudi Arabia