Bupivacaine Liposomal Injection (Exparel) for Postsurgical Analgesia in Patient Undergoing Laparoscopic Bariatric Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Despite the increasing use of patient-controlled anesthesia (PCA) for postoperative pain
      management, efforts are continuing to find effective methods to relieve pain after abdominal
      surgery. Although opioid is an effective analgesic it has opioid related adverse events
      (ORAEs). Bupivacaine should reduce postoperative pain but it has relatively shorter duration
      of action. Liposome bupivacaine (Exparel) has been approved as a single dose infiltration for
      longer postoperative period analgesic. It provides up to 72 hours analgesia postoperatively;
      results in lesser opioids usage and reduce the ORAEs. Transversus abdominis plane (TAP) block
      is a relatively new regional anesthetic technique. TAP blocks have been performed to reduce
      opioid use and control pain in several laparoscopic surgical procedures, including colorectal
      resections, cholecystectomy and bariatric surgery. The aim of this study is to study the
      opiate usage, pain and nausea post laparoscopic gastric bypass or sleeve gastrectomy using
      Exparel versus Bupivacaine as TAP block and port sites infiltration.
    

Detailed description: 
      Introduction

      Despite the increasing use of patient-controlled anesthesia (PCA) for postoperative pain
      management, efforts are continuing to find effective methods to relieve pain after abdominal
      surgery. Some studies have already suggested that infusion with local anesthetics at the
      wound site can decrease postoperative pain levels. Further, other studies have shown equal
      amounts of opiate analgesic requirements (administered on patient demand) with placebo and
      local anesthetic administration. However, varying anesthetic administration techniques used
      in the different studies may explain why the controversy in the literature exists.

      Although opioid is an effective analgesic it has opioid related adverse events (ORAEs).
      Bupivacaine should reduce postoperative pain but it has relatively shorter duration of
      action. Liposome bupivacaine (Exparel) has been approved as a single dose infiltration for
      longer postoperative period analgesic. It provides up to 72 hours analgesia postoperatively;
      results in lesser opioids usage and reduce the ORAEs.

      Transversus abdominis plane (TAP) block is a relatively new regional anesthetic technique
      that targets blockage of the neural afferent of the lower intercostal, iliohypogastric and
      ilioinguinal nerves in the neurovascular plane between the internal oblique and the
      transversus abdominis muscle. TAP blocks have been performed to reduce opioid use and control
      pain in several laparoscopic surgical procedures, including colorectal resections,
      cholecystectomy and bariatric surgery.

      Efficacy of wound infiltration with or without TAP block using immediate-release bupivacaine
      HCl for acute postsurgical pain is well established; EXPAREL has been proposed as a method
      for postoperative pain management. Moreover, the administration and the optimal dosage in the
      bariatric surgical population have not been studied.

      The objective of this study is to examine postoperative pain after laparoscopic gastric
      bypass with TAP block and port sites infiltration using Exparel versus Bupivacaine

      Background and significance

      Exparel is a FDA approved long-acting, local anesthetic. This is for single-dose infiltration
      into the surgical site to produce postsurgical analgesia. Exparel offers longer-acting local
      formulation and can be administered as a single dose. Exparel has a longer duration of action
      with slower absorption. The mean elimination half-life of local administration of Exparel is
      approximately 24-34 hours 19-20 versus 2.7 hours for bupivacaine.

      Liposomal bupivacaine is for single-dose infiltration and the recommended dose depends on the
      surgical site but the maximum dose of liposomal bupivacaine is 266 mg and it is injected into
      soft tissues of the surgical site with frequent aspirations to prevent intravascular
      injection.

      A pooled analysis evaluating the effect of Exparel on pain intensity scores and opioid
      consumption was published by Dasta et al. This study included 5 surgical procedures (inguinal
      hernia repair, total knee replacement, hemorrhoidectomy, breast augmentation and
      bunionectomy) comparing Exparel with bupivacaine HCl, on 912 patients; it showed
      significantly lower pain score and opioid usage, delayed use of rescue opioid and reduced
      ORAEs in the Exparel group; as compared to bupivacaine HCL group.

      Medication SafetLiposomal bupivacaine has been classified as a high-alert medication by the
      Institute of Safe Medication Practices due to its similar appearance to propofol. If
      liposomal bupivacaine were administered intravenously as if it were propofol, adverse cardiac
      effects may result.

      Hypothesis

      Exparel (1.3%) and 0.5% Bupivacaine usage with infiltration and TAP block decreases opiate
      usage, nausea and pain at 48 hours as compared to 0.5% Bupivacaine only.

      Primary Objective of the study:

      To study the opiate usage, pain and nausea post laparoscopic gastric bypass or sleeve
      gastrectomy using EXPAREL versus Bupivacaine as TAP block and port sites infiltration.
    

Intervention name(s): Exparel; Bupivacain; Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Exparel will be injected at port sites.; 6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Bupivacain will be injected at port sites.
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment