A Comparison of Bupivacaine and Ketorolac for Postoperative Analgesia After Iliac Crest Bone Harvesting

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effectiveness of Bupivicaine Infusion Versus Intravenous Ketorolac for Postoperative Analgesia After Iliac Crest Bone Harvesting for Lefort I Osteotomy or Alveolar Cleft Repair.

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Ketorolac
* Drug: Bupivacaine
* Drug: ketorolac + bupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Ketorolac<br>* 0.5 mg•kg-1 IV at the end of surgery before extubation and then 3 additional doses every 8 hours thereafter<br>|
| Experimental: 2<br> | Drug: Bupivacaine<br>* 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.<br>|
| Experimental: 3<br> | Drug: ketorolac + bupivacaine<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain, assessed with a numerical analog system |  | As soon as the patient is able to respond appropriately and then approximately every 4 hours for 48 hours | 
| Patient satisfaction score |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption |  | Every 4 hours | 
| Total number of episodes of nausea, vomiting, and pruritis |  | 48 hours | 
| Doses of all anti-emetics |  | 48 hours | 
| Heart rate and respiratory rate variables |  | 48 hours | 
| Time to first ambulation |  | Time determined by outcome | 
| Wound healing at iliac crest site |  | 1, 4, 8 and 16 weeks post-operatively | 
| X-ray data on recipient site |  | 1, 4, 8 and 16 weeks post-operatively | 
| Clinical assessment of recipient site |  | 1, 4, 8 and 16 weeks post-operatively | 
| Plasma bupivacaine levels |  | Before bolus and at 0.5, 1, 6, 12 and 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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orthopedic surgery, Pediatrics, Postoperative Analgesia, Iliac Crest Bone Graft, Osteotomy, cleft palate