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

The Hospital for Sick Children

Status and phase

Completed

Phase 3

Conditions

Postoperative Pain

Treatments

Drug: Bupivacaine

Drug: Ketorolac

Drug: ketorolac + bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT00405262

1000008719

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 patients

Sex

All

Ages

10 to 20 years old

Volunteers

No 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