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Pain Relief at Iliac Crest Bone Harvest Sites in Spine Surgery Using Bupivacaine

NCT01087931 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-06-25

Study results available
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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.

Conditions

Interventions

DRUG

Bupivacaine

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

OTHER

Normal Saline

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

Sponsors & Collaborators

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Kevin R O'Neill, MD, MS · Vanderbilt University Medical Center, Department or Orthopaedics

  • Richard A Davis, MD · Vanderbilt University Medical Center, Department or Orthopaedics

  • Clint Devin, MD · Vanderbilt University Medical Center, Department or Orthopaedics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01087931 on ClinicalTrials.gov