A Comparison of Bupivacaine and Ketorolac for Postoperative Analgesia After Iliac Crest Bone Harvesting
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The efficacy of three postoperative pain management regimens will be compared in patients
      undergoing Lefort I osteotomy or alveolar cleft repair with Iliac crest bone grafts (ICBG) to
      determine the best way of managing postoperative pain.
    

Detailed description: 
      Iliac crest bone grafts (ICBG) are used for many types of surgeries including alveolar cleft
      repair, Lefort I osteotomies, spinal fusion, and fracture management. ICBG donor sites are
      notoriously painful, and the pain is often more severe than that from the primary operative
      site.

      Postoperative pain management after operations that involve harvesting ICBG usually includes
      opioids, which are most often delivered by a patient-controlled device. Additional analgesics
      may include acetaminophen, non-steroidal anti-inflammatory (NSAID) drugs, and local
      anesthetic agents, such as bupivacaine or ropivacaine. Local anesthetics may also be injected
      intermittently or continuously into the wound via an indwelling catheter inserted at the time
      of surgery. All but one of these studies have shown a significant reduction in pain scores
      and opioid consumption using local anesthetic through an indwelling catheter.

      Only one study has investigated the effects of NSAIDs on postoperative ICBG pain. This study
      found that intravenous ketorolac did not reduce morphine consumption. However, there was a
      trend to lower morphine use with ketorolac, and pain and patient satisfaction scores were not
      measured.

      Currently, we do not use local anesthetic infusions via an indwelling iliac crest catheter
      for patients at our institution undergoing Lefort I osteotomy or alveolar cleft repair with
      ICBG since we find the above pain management regimen to be effective, with most patients
      using low to moderate amounts of morphine. To our knowledge, no study to date has compared
      the efficacy of ketorolac to local anesthetic infusions for patients undergoing Lefort I
      osteotomy or alveolar cleft repair with ICBG.
    

Intervention name(s): Ketorolac; Bupivacaine; ketorolac + bupivacaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.5 mg•kg-1 IV at the end of surgery before extubation and then 3 additional doses every 8 hours thereafter; 0.2 mL•kg-1 (lean body mass) bolus of bupivacaine 0.25% with epinephrine 1:200 000 will be injected through the IC catheter at the end surgery before the patient's trachea is extubated to detect intravascular injection. An infusion of the same solution will be started at 0.1 mL•kg-1•hour-1 (lean body mass) for 24 hours.; 0.2 mL•kg-1 (lean body mass) bolus of bupivacaine 0.25% with epinephrine 1:200 000 will be injected through the IC catheter at the end surgery before the patient's trachea is extubated to detect intravascular injection. An infusion of the same solution will be started at 0.1 mL•kg-1•hour-1 (lean body mass) for 24 hours.
For ketorolac, patients will receive 0.5 mg•kg-1 IV at the end of surgery before extubation and then 3 additional doses every 8 hours thereafter
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pediatrics; Postoperative Analgesia; orthopedic surgery; Iliac Crest Bone Graft; Osteotomy; cleft palate