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Completed

NCT Number: NCT00405262

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

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.

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Key information

Conditions

Postoperative Pain Cleft Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

10 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac

Drug

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

Bupivacaine

Drug

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

Drug

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 outcomes

  1. 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

  2. Patient satisfaction score

    Time frame: 24 hours

Secondary outcomes

  1. Morphine consumption

    Time frame: Every 4 hours

  2. Total number of episodes of nausea, vomiting, and pruritis

    Time frame: 48 hours

  3. Doses of all anti-emetics

    Time frame: 48 hours

  4. Heart rate and respiratory rate variables

    Time frame: 48 hours

  5. Time to first ambulation

    Time frame: Time determined by outcome

  6. Wound healing at iliac crest site

    Time frame: 1, 4, 8 and 16 weeks post-operatively

  7. X-ray data on recipient site

    Time frame: 1, 4, 8 and 16 weeks post-operatively

  8. Clinical assessment of recipient site

    Time frame: 1, 4, 8 and 16 weeks post-operatively

  9. Plasma bupivacaine levels

    Time frame: Before bolus and at 0.5, 1, 6, 12 and 24 hours

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 30, 2006
Registry last updated
Aug 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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