Clinical trial NCT00405262: A Comparison of Bupivacaine and Ketorolac for Postoperative Analgesia After Iliac Crest Bone Harvesting
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Keywords: Pediatrics
Postoperative Analgesia
orthopedic surgery
Iliac Crest Bone Graft
Osteotomy
cleft palate
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2006-11-30
Enrollment: 54
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Pain, assessed with a numerical analog system
timeFrame: As soon as the patient is able to respond appropriately and then approximately every 4 hours for 48 hours
measure: Patient satisfaction score
timeFrame: 24 hours
Secondary outcomes:
measure: Morphine consumption
timeFrame: Every 4 hours
measure: Total number of episodes of nausea, vomiting, and pruritis
timeFrame: 48 hours
measure: Doses of all anti-emetics
timeFrame: 48 hours
measure: Heart rate and respiratory rate variables
timeFrame: 48 hours
measure: Time to first ambulation
timeFrame: Time determined by outcome
measure: Wound healing at iliac crest site
timeFrame: 1, 4, 8 and 16 weeks post-operatively
measure: X-ray data on recipient site
timeFrame: 1, 4, 8 and 16 weeks post-operatively
measure: Clinical assessment of recipient site
timeFrame: 1, 4, 8 and 16 weeks post-operatively
measure: Plasma bupivacaine levels
timeFrame: Before bolus and at 0.5, 1, 6, 12 and 24 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Jason Hayes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hayes JA, Forrest CR, Walsh W, Petroz GC, Adeli K, Bissonnette B. Continuous bupivacaine infusion post-iliac crest bone graft harvesting in pediatric cleft surgery: role and comparison with ketorolac. Cleft Palate Craniofac J. 2011 Sep;48(5):532-7. doi: 10.1597/10-148. Epub 2010 Nov 23.