A Comparison of Bupivacaine and Ketorolac for Postoperative Analgesia After Iliac Crest Bone Harvesting
- Conditions
- Postoperative Pain
- Interventions
- Registration Number
- NCT00405262
- Lead Sponsor
- The Hospital for Sick Children
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- 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
- Allergy, sensitivity or contraindication to any non-steroidal anti-inflammatory drugs
- Allergy, sensitivity or contraindication to morphine
- History of gastric ulcer or bleeding diathesis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Ketorolac - 2 Bupivacaine - 3 ketorolac + bupivacaine -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada