Pain Relief at Iliac Crest Bone Harvest Sites in Spine Surgery Using Bupivacaine
Completed · Not applicable
Conditions studied: Pain
In brief
The use of iliac crest bone graft (ICBG) remains the gold-standard in spinal reconstructive surgery for achieving fusion. Major complications from the harvesting of ICBG are rare, but chronic pain has been reported in 10-39%. Catheters implanted at the time of surgery have been used to provide local anesthetic at the harvest site for 24-48 hours after surgery. This has been shown to decrease chronic pain at 4 years post-operatively. A single application of local anesthetic at surgery has been shown to decrease pain at the harvest site for up to 5 days. No study has demonstrated a benefit to using a single application of local anesthetic at the ICBG site beyond 5 days. In current clinical practice, the use of a local anesthetic at the ICBG site is determined according to surgeon preference. The purpose of this study is to determine if a single application of bupivacaine at the ICBG site, as currently done in some cases, provides any pain relief beyond 5 days such as that demonstrated with longer infusions of local anesthetics.
Key facts
- Study ID
- NCT01087931
- Run by
- Vanderbilt University
- People needed
- 40
- Starts
- 2010-04-01
- Expected to finish
- 2011-10-01
- Last updated by the study team
- 2018-06-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- patients 18 years of age or older undergoing posterior cervical, thoracic, or lumbar surgery
- willingness to participate in the study.
You may not qualify if…
- individuals who underwent surgical intervention in the past 6 months
- previous iliac crest bone harvesting
- history of tumor and spondyloarthropathies (rheumatoid arthritis, seronegative arthritis)
- history of adverse reaction to local anesthetic
- history of severe pelvic and hip conditions that can interfere with the outcome assessment of the study
- opioid addiction
- pregnancy
- acute mental illness
- uncontrolled major depression and any other psychiatric disorders
- prisoners
- non-english speaking patients
- inability to understand the informed consent and demands of the study.
Where it is running
- Vanderbilt Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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