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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 system

Patient satisfaction score

Secondary outcome:

Morphine consumption

Total 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

Page last updated: August 23, 2015

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