A Comparison of Bupivacaine and Ketorolac for Postoperative Analgesia After Iliac Crest Bone Harvesting - Full Text View

Sponsored by:	The Hospital for Sick Children
Information provided by:	The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00405262

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 III

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Ketorolac Ketorolac tromethamine Epinephrine Epinephrine bitartrate Bupivacaine Bupivacaine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
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.

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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
1: Active Comparator	Drug: Ketorolac 0.5 mg•kg-1 IV at the end of surgery before extubation and then 3 additional doses every 8 hours thereafter
2: Experimental	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.
3: Experimental	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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405262

Contacts

Contact: Jason Hayes, MD

416-813-8963

jason.hayes@sickkids.ca

Locations

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

Sponsors and Collaborators

The Hospital for Sick Children

Investigators

Principal Investigator:

Jason Hayes, MD

The Hospital for Sick Children, Toronto Canada

More Information

Responsible Party:	The Hospital for Sick Children ( Jason Hayes/Principal Investigator )
Study ID Numbers:	1000008719
Study First Received:	November 28, 2006
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00405262
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

Study placed in the following topic categories:

Cleft Palate
Signs and Symptoms
Postoperative Complications
Ketorolac
Bupivacaine

Pain
Epinephrine
Ketorolac Tromethamine
Pain, Postoperative

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Enzyme Inhibitors
Anesthetics, Local
Pharmacologic Actions

Pathologic Processes
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009