N/A
N=40
Pain Relief at Iliac Crest Bone Harvest Sites in Spine Surgery Using Bupivacaine
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01087931 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Pain, Cumulative Visual Analog Score, 1st Follow Up — 10.5; 21.7 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bupivacaine (Drug); Normal Saline (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain, Cumulative Visual Analog Score, 1st Follow Up |
10.5; 21.7 | — |
| PRIMARY Pain, Cumulative Visual Analog Score, Final Follow up |
15.33; 29.33 | — |
| SECONDARY Narcotic Use, 1st Follow up |
9; 13 | — |
| SECONDARY Narcotic Use, Final Follow up |
1; 3 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- patients 18 years of age or older undergoing posterior cervical, thoracic, or lumbar surgery
- willingness to participate in the study.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01087931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.