Efficacy of CPPLAI in Laparoscopic Sleeve Gastrectomy Patients
Condition: Obesity, Morbid; Pain, Postoperative
MeSH terms: Obesity, Morbid; Pain, Postoperative
Study type: Interventional

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.
    

Intervention name(s): CPPLAI; Placebo; Bupivacaine 0.25%
Intervention type(s): Procedure; Other; Drug
Intervention description(s): In this intervention, after general anesthesia patients will receive intraoperative combined periportal and preperitoneal bupivacaine 0.25% 2-3 mg/kg diluted in 40 ml normal saline.; In this intervention, after general anesthesia patients will receive intraoperative combined periportal and preperitoneal 40 ml of sterile water.; In this intervention, after general anesthesia patients will receive intraoperative combined periportal and preperitoneal bupivacaine 0.25% 2-3 mg/kg diluted in 40 ml normal saline.
Other intervention name(s): Bupivacaine 0.25%; Sterile water; CPPLAI
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 117 adult patients scheduled for Laparoscopic Sleeve Gastrectomy (LSG) will be recruited in this prospective clinical study. The patients will be divided into two groups; 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 and group 2 (placebo) (n= 58) periportal and preperitoneal 40 ml of sterile water will be injected.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Laparoscopic sleeve gastrectomy; post operative pain; local anesthetic infiltration; Periportal; Preperitoneal; Morbid obesity