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

NCT01087931 | Completed Results

• 1 other identifier: 100096
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Pain

Keywords

Local anesthetic; Iliac crest bone harvest; Patients undergoing spine surgery that require use of iliac crest bone autograft

Outcome Measures

Primary Outcomes (2)

• Pain, Cumulative Visual Analog Score, 1st Follow Up

  Cumulative Visual Analog Score pain score scores were calculated using the sum of scores (at rest and with movement, pain on average at rest and with movement, and maximum pain at rest and with movement) Range = 0-60 for cumulative visual analog pain score with 0=no pain and 60=worst pain ever.

  about 4 to 5 weeks after surgery

• Pain, Cumulative Visual Analog Score, Final Follow up

  Cumulative Visual Analog Score pain score scores were calculated using the sum of scores (at rest and with movement, pain on average at rest and with movement, and maximum pain at rest and with movement) Range = 0-60 for cumulative visual analog pain score with 0=no pain and 60=worst pain ever.

  about 18 to 20 weeks after surgery

Secondary Outcomes (2)

• Narcotic Use, 1st Follow up

  about 4 to 5 weeks after surgery

• Narcotic Use, Final Follow up

  about 18 to 20 weeks after surgery

Study Arms (2)

Bupivacaine

ACTIVE COMPARATOR

This group will receive bupivacaine (10ml of 0.5%) administered directly into the surgical wound at the iliac crest bone harvest site.

Drug: Bupivacaine

Saline

PLACEBO COMPARATOR

This group will receive normal saline (10ml) administered directly into the surgical wound at the iliac crest bone harvest site.

Other: Normal Saline

Interventions

Bupivacaine DRUG

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

Also known as: Marcaine.

Bupivacaine

Normal Saline OTHER

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

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt Medical Center

Nashville, Tennessee, 37209, United States

Location

Related Publications (1)

• O'Neill KR, Lockney DT, Bible JE, Crosby CG, Devin CJ. Bupivacaine for pain reduction after iliac crest bone graft harvest. Orthopedics. 2014 May;37(5):e428-34. doi: 10.3928/01477447-20140430-52.

  PMID: 24810818 RESULT

MeSH Terms

Conditions

Pain

Interventions

Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Original Study data cannot be found. Data for this record was pulled from the publication, Bupivacaine for pain reduction after iliac crest bone graft harvest, PMID: 24810818.

Results Point of Contact

• Title: Kevin O'Neill
• Organization: Vanderbilt University

615-936-5677

Study Officials

• Kevin R O'Neill, MD, MS

  Vanderbilt University Medical Center, Department or Orthopaedics

  PRINCIPAL INVESTIGATOR

• Richard A Davis, MD

  Vanderbilt University Medical Center, Department or Orthopaedics

  STUDY CHAIR

• Clint Devin, MD

  Vanderbilt University Medical Center, Department or Orthopaedics

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 16, 2010
• Study Start: April 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: June 25, 2018
• Results First Posted: June 25, 2018

Record last verified: 2018-05

Locations

US (1)