Intraoperative TAP Block With Bupivacaine/Dexamethasone Against Liposomal Bupivacaine (Exparel®)
Condition: Pain, Postoperative; Crohn Disease; Inflammatory Bowel Diseases; Colorectal Cancer; Gastrointestinal Cancer; Gastrointestinal Disease; Digestive System Disease; Pain; Pain, Neuropathic; Intestinal Disease
MeSH terms: Gastrointestinal Neoplasms; Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases; Gastrointestinal Diseases; Digestive System Diseases; Neuralgia; Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Traditionally, opioids are heavily utilized in treating postoperative pain but they are
      associated with numerous side effects. The use of the transversus abdominis plane (TAP)
      blocks have become standard practice to extend the post-operative analgesic window and limit
      opioid use. A new liposomal-depo formulation of bupivacaine (Exparel) has gained popularity
      as a long-lasting TAP block medication, but has not been studied in a well-powered clinical
      trial specifically in colorectal patients nor compared to a bupivacaine/steroid mixture which
      may offer similar effects. We conduct a prospective randomized prospective randomized study
      of patients undergoing major laparoscopic colorectal surgery to compare the analgesic effects
      of a bupivacaine/steroid mixture versus liposomal bupivacaine.
    

Detailed description: 
      Postoperative pain can pose significant challenges in the postoperative recovery of patients
      undergoing major colorectal surgery. Traditionally, opioids have played an important role in
      treating postoperative pain. It is well established that opioids are highly effective in
      relieving pain; however, opioids are associated with numerous side effects that include
      nausea, vomiting, constipation, ileus, bladder dysfunction, respiratory depression, pruritus,
      drowsiness, sedation, and allergic reaction. These opioid side effects, which range in
      severity, can significantly interfere with discharge home, particularly following colorectal
      surgery. Significant interest has grown for the use of guided regional anesthesia,
      specifically the use of the transversus abdominis plane (TAP) block to extend the
      post-operative analgesic window and ultimately limit opioid use. While bupivacaine
      formulations including a steroid has been shown to prolong the anesthetic effects of the
      regional field block, a new liposomal-depo formulation of bupivacaine (Exparel) has gained
      popularity and has additionally been shown to provide extended analgesia. Although promising
      data exists surrounding each modality, liposomal bupivacaine has not been studied in a
      well-powered clinical trial specifically in colorectal patients nor compared to a
      bupivacaine/steroid mixture.

      We are proposing a prospective randomized study of patients undergoing major laparoscopic
      colorectal surgery to compare the analgesic effects of a bupivacaine/steroid mixture versus
      liposomal bupivacaine (Exparel). We hypothesize that the liposomal formulation of bupivacaine
      will provide superior perioperative pain control at 48 hours post-operation measured by total
      consumed oral morphine equivalents. In addition, we will measure postoperative pain scores,
      time until ambulation, antiemetic use, length of postoperative hospital stay, postoperative
      ileus, and adverse events directly related or unrelated to TAP block in the 30-day
      postoperative period between the three groups.
    

Intervention name(s): Liposomal bupivacaine; Bupivacaine/epinephrine/dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): Liposomal bupivacaine will be given during the bilateral laparoscopic-guided TAP block given to each patient intraoperatively.; Bupivacaine/epinephrine/dexamethasone will be given during the bilateral laparoscopic-guided TAP block administered to each patient intraoperatively.
Other intervention name(s): Exparel; Decadron
Intervention MeSH terms: Dexamethasone; Epinephrine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: transversus abdominis plane block; tap block; liposomal bupivacaine; exparel; dexamethasone; colorectal surgery; regional anesthesia; bupivacaine; surgery; postoperative pain; pain