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

Postoperative Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405262
• Other study ID #: 1000008719
• Status: Completed
• Phase: Phase 3
• First received: November 28, 2006
• Last updated: August 19, 2013
• Start date: May 2006
• Est. completion date: October 2008

Study information

• Verified date: August 2013
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 20 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Patient satisfaction score		24 hours	No
Secondary	Morphine consumption		Every 4 hours	No
Secondary	Total number of episodes of nausea, vomiting, and pruritis		48 hours	No
Secondary	Doses of all anti-emetics		48 hours	No
Secondary	Heart rate and respiratory rate variables		48 hours	No
Secondary	Time to first ambulation		Time determined by outcome	No
Secondary	Wound healing at iliac crest site		1, 4, 8 and 16 weeks post-operatively	No
Secondary	X-ray data on recipient site		1, 4, 8 and 16 weeks post-operatively	No
Secondary	Clinical assessment of recipient site		1, 4, 8 and 16 weeks post-operatively	No
Secondary	Plasma bupivacaine levels		Before bolus and at 0.5, 1, 6, 12 and 24 hours	No