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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Ketorolac
Bupivacaine
ketorolac + bupivacaine
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Pediatrics, Postoperative Analgesia, orthopedic surgery, Iliac Crest Bone Graft, Osteotomy, cleft palate

Eligibility Criteria

10 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

Pain, assessed with a numerical analog system
Patient satisfaction score

Secondary Outcome Measures

Morphine consumption
Total number of episodes of nausea, vomiting, and pruritis
Doses of all anti-emetics
Heart rate and respiratory rate variables
Time to first ambulation
Wound healing at iliac crest site
X-ray data on recipient site
Clinical assessment of recipient site
Plasma bupivacaine levels

Full Information

First Posted
November 28, 2006
Last Updated
August 19, 2013
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT00405262
Brief Title
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

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Pediatrics, Postoperative Analgesia, orthopedic surgery, Iliac Crest Bone Graft, Osteotomy, cleft palate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Intervention Description
0.5 mg•kg-1 IV at the end of surgery before extubation and then 3 additional doses every 8 hours thereafter
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
ketorolac + bupivacaine
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Title
Patient satisfaction score
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Morphine consumption
Time Frame
Every 4 hours
Title
Total number of episodes of nausea, vomiting, and pruritis
Time Frame
48 hours
Title
Doses of all anti-emetics
Time Frame
48 hours
Title
Heart rate and respiratory rate variables
Time Frame
48 hours
Title
Time to first ambulation
Time Frame
Time determined by outcome
Title
Wound healing at iliac crest site
Time Frame
1, 4, 8 and 16 weeks post-operatively
Title
X-ray data on recipient site
Time Frame
1, 4, 8 and 16 weeks post-operatively
Title
Clinical assessment of recipient site
Time Frame
1, 4, 8 and 16 weeks post-operatively
Title
Plasma bupivacaine levels
Time Frame
Before bolus and at 0.5, 1, 6, 12 and 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Hayes, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21091369
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.
Results Reference
derived

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

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