A Comparison of Bupivacaine and Ketorolac for Postoperative Analgesia After Iliac Crest Bone Harvesting
Information source: The Hospital for Sick Children
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain
Intervention: Ketorolac (Drug); Bupivacaine (Drug); ketorolac + bupivacaine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: The Hospital for Sick Children Official(s) and/or principal investigator(s): Jason Hayes, MD, Principal Investigator, Affiliation: The Hospital for Sick Children, Toronto Canada
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.
Clinical Details
Official title: The Effectiveness of Bupivicaine Infusion Versus Intravenous Ketorolac for Postoperative Analgesia After Iliac Crest Bone Harvesting for Lefort I Osteotomy or Alveolar Cleft Repair.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Pain, assessed with a numerical analog systemPatient satisfaction score
Secondary outcome: Morphine consumptionTotal number of episodes of nausea, vomiting, and pruritis Doses of all anti-emetics Heart rate and respiratory rate variables Time to first ambulation Wound healing at iliac crest site X-ray data on recipient site Clinical assessment of recipient site Plasma bupivacaine levels
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.
Eligibility
Minimum age: 10 Years.
Maximum age: 20 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Alveolar bone graft patients age 10-13 years of age
- Lefort I osteotomy patients needing ICBG age 14 to 20 years
- able to operate a patient-controlled analgesia (PCA) device
Exclusion Criteria:
- Allergy, sensitivity or contraindication to any non-steroidal anti-inflammatory drugs
- Allergy, sensitivity or contraindication to morphine
- History of gastric ulcer or bleeding diathesis
Locations and Contacts
The Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada
Additional Information
Starting date: May 2006
Last updated: August 19, 2013
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