TAP Block With Plain Bupivacaine Versus Wound Infiltration With Exparel for Postoperative Pain Management
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      In this randomized, controlled, observer-blinded study we plan to evaluate pain relief after
      ultrasound-guided transversus abdominis plane (TAP) block using bupivacaine and wound
      infiltration using liposomal bupivacaine in patients undergoing abdominal hysterectomy.
    

Detailed description: 
      Patients undergoing open total abdominal hysterectomy at Parkland Hospital (n=60) will be
      randomized into one of two groups to receive either ultrasound-guided bilateral TAP block
      with bupivacaine (Group 1) or infiltration of the surgical wound with liposomal bupivacaine
      (Group 2) for postoperative pain management. The remaining aspect of perioperative care,
      including the general anesthetic technique, postoperative care will be standardized and will
      be similar for all patients. The duration of the involvement in the study will be until 48
      hours postoperatively. The pre-anesthesia care unit personnel will identify patients during
      their preoperative clinic visit.

      Patients in Group 1 will receive ultrasound-guided bilateral TAP block at the end of the
      surgery. Patients in Group 2 will receive Exparel prior to closing the incision which will be
      injected subfascially and subcutaneously. In the first 24-h postoperative period, patients in
      both Groups will receive acetaminophen 1000 mg every 6 h orally, ketorolac 30 mg, IV every 6
      h, orally and morphine via an intravenous patient controlled analgesia (IV-PCA) system to
      maintain adequate pain control. In the 24-48 h study period, all patients will receive oral
      ibuprofen 800 mg and acetaminophen 1000 mg three times a day and a combination of
      hydrocodone/acetaminophen 5mg/ 325 mg 1-2 tablets, as needed.

      The postoperative analgesia will be documented using the visual analog score (0=no pain,
      10=worst pain). In addition, total opioid dose over the 48-h study period will be documented.
      Postoperative nausea will be measured using a categorical scoring system (none=0, mild=1,
      moderate=2, severe=3) and episodes of vomiting will be documented. Rescue antiemetics will be
      given to any patient who complains of nausea and/or vomiting.

      All variables will be assessed at 2, 6, 12, 24, and 48 hours, postoperatively by an
      investigator blinded to group allocation.
    

Intervention name(s): Plain bupivacaine; Liposomal bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Intraoperative: TAP block with plain bupivacaine + Acetaminophen 1000 mg IV + Ketorolac 30 mg IV .
First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine.
24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h,prn; Group intraoperative: Wound infiltration with liposomal bupivacaine (Exparel) + IV acetaminophen 1000 mg IV + Ketorolac 30 mg IV
First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine
24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn
Other intervention name(s): Bupivacaine Hydrochloride; Exparel
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pain, Liposomal bupivacaine, Wound infiltration