A Comparison of Bupivacaine and Ketorolac for Postoperative Analgesia After Iliac Crest Bone Harvesting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Postoperative Pain |
Drug: Ketorolac Drug: Bupivacaine Drug: ketorolac + bupivacaine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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. |
- Pain, assessed with a numerical analog system [ Time Frame: As soon as the patient is able to respond appropriately and then approximately every 4 hours for 48 hours ] [ Designated as safety issue: No ]
- Patient satisfaction score [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Morphine consumption [ Time Frame: Every 4 hours ] [ Designated as safety issue: No ]
- Total number of episodes of nausea, vomiting, and pruritis [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- Doses of all anti-emetics [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- Heart rate and respiratory rate variables [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- Time to first ambulation [ Time Frame: Time determined by outcome ] [ Designated as safety issue: No ]
- Wound healing at iliac crest site [ Time Frame: 1, 4, 8 and 16 weeks post-operatively ] [ Designated as safety issue: No ]
- X-ray data on recipient site [ Time Frame: 1, 4, 8 and 16 weeks post-operatively ] [ Designated as safety issue: No ]
- Clinical assessment of recipient site [ Time Frame: 1, 4, 8 and 16 weeks post-operatively ] [ Designated as safety issue: No ]
- Plasma bupivacaine levels [ Time Frame: Before bolus and at 0.5, 1, 6, 12 and 24 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 54 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | October 2008 |
| Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: Ketorolac
0.5 mg•kg-1 IV at the end of surgery before extubation and then 3 additional doses every 8 hours thereafter
|
| Experimental: 2 |
Drug: Bupivacaine
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.
|
| Experimental: 3 |
Drug: ketorolac + bupivacaine
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 |
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| Ages Eligible for Study: | 10 Years to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Jason Hayes, MD | 416-813-8963 | jason.hayes@sickkids.ca |
| Canada, Ontario | |
| The Hospital for Sick Children | Recruiting |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Contact: Jason Hayes, MD 416 813 8963 jason.hayes@sickkids.ca | |
| Principal Investigator: Jason Hayes, MD | |
| Sub-Investigator: Victor Espinal, MD | |
| Sub-Investigator: Guy Petroz, MD | |
| Sub-Investigator: Christopher Forrest, MD | |
| Sub-Investigator: Khosrow Adeli, MD | |
| Sub-Investigator: Bruno Bissonnette, MD | |
| Principal Investigator: | Jason Hayes, MD | The Hospital for Sick Children, Toronto Canada |
More Information
No publications provided
| Responsible Party: | Jason Hayes/Principal Investigator, The Hospital for Sick Children |
| ClinicalTrials.gov Identifier: | NCT00405262 History of Changes |
| Other Study ID Numbers: | 1000008719 |
| Study First Received: | November 28, 2006 |
| Last Updated: | August 13, 2008 |
| Health Authority: | Canada: Health Canada |
Keywords provided by The Hospital for Sick Children:
|
Pediatrics Postoperative Analgesia orthopedic surgery |
Iliac Crest Bone Graft Osteotomy cleft palate |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Bupivacaine Ketorolac Ketorolac Tromethamine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013