CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Bupivacaine +1 moredrug
Likely dose
Bupivacaine 10mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01087931
NCT01087931N/ACompleted

Local Anesthetic Use at Iliac Crest Bone Graft Site in Spinal Reconstructive Surgery

Vanderbilt University·interventional·Posted Mar 16, 2010·Updated Jun 25, 2018

In Brief

A clinical study evaluating Bupivacaine and Normal Saline for Pain. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 16, 2010
Enrollment StartApr 1, 2010
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.3 years ago

Interventions

Bupivacainedrug

Single application of 10ml of bupivacaine 0.5% into the iliac crest bone harvest surgical site.

Normal Salineother

Normal saline 0.9%, 10ml, single application directly into iliac crest bone harvest surgical site.