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NCT01087931 · ClinicalTrials.gov registry record · NA
Pain Relief at Iliac Crest Bone Harvest Sites in Spine Surgery Using Bupivacaine
A NA study, sponsored by Vanderbilt University.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT01087931 is a NA study that has completed, run by Vanderbilt University. The registered enrollment target is 40 participants.
The verdict
NCT01087931, a NA study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study 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.
Interventions
- DRUG Bupivacaine
- OTHER Normal Saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2010-04 |
| Est. Completion | 2011-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01087931
The ClinicalTrials.gov registry entry for NCT01087931 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Bupivacaine is the first listed.
NCT01087931 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01087931 about?
NCT01087931 is a clinical study titled "Pain Relief at Iliac Crest Bone Harvest Sites in Spine Surgery Using Bupivacaine". 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...
What is the current status of trial NCT01087931?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2010-04. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01087931?
The interventions under investigation include: Bupivacaine (DRUG), Normal Saline (OTHER).
Who is sponsoring clinical trial NCT01087931?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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