Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01087931
Recruitment Status : Completed
First Posted : March 16, 2010
Results First Posted : June 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Vanderbilt University Medical Center ( Vanderbilt University )

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Bupivacaine Other: Normal Saline Not Applicable

Detailed Description:

The use of local anesthetic at the donor site has been investigated to decrease the morbidity of iliac crest bone harvesting. Along with a decrease in early post-operative pain that may be expected a decrease in chronic pain and improved long-term results have also been demonstrated. Local anesthetics may cause such long-term results by dampening the initial chemical response to injury by reducing the release of inflammatory mediators from neutrophils, neutrophil adhesion to the endothelium, and the formation of free oxygen radicals. Most studies have utilized continuous or periodic infusions of anesthetic through a catheter placed at the time of surgery for 24-48 hours postoperatively. The drawbacks to using a catheter include increased infection risk and increased cost if a continuous infusion is used . A single treatment of local anesthetic at the time of surgery is therefore preferable. Only one study has evaluated a single injection of local anesthetic in adult spine patients, demonstrating decreased pain and narcotic usage through 5 post-operative days. No study to date has demonstrated a decrease in intermediate or long-term donor site pain through a single application of anesthetic, as achieved in previous studies utilizing post-operative infusions via a catheter.

Participants in the study will be identified in by the attending surgeons on this study who are clinical faculty within the department of orthopaedics and board certified in spine surgery. Randomization will be done by random selection of a sealed envelope by the attending physician at the time of enrollment. Sealed envelopes will contain a paper that assigns the patient to the treatment (bupivacaine at bone harvest site) or placebo (normal saline at bone harvest site) group. Note that all surgical wounds are routinely irrigated with normal saline prior to skin closure. In the control group, 10ml more of normal saline will be used in the ICBG site. In the treatment group, 10ml of bupivacaine 0.5% will be administered directly into the surgical wound, as done in some cases currently. Therefore, there are no new procedures in this protocol outside of what is already being done in practice. The current practice of using versus not using local anesthetic at the iliac crest bone graft site is at the discretion of the attending surgeon. Please note that the randomization in this study has nothing to do with the surgery that is done, and all patients will be treated according to standard of care regardless of this randomization. There are no other differences between treatments in the two study groups. There are no deviations from normal post-operative care received.

Patients will not be told whether or not they receive bupivacaine at the iliac crest bone graft site at the time of surgery. The patient will be blinded to their treatment group throughout the study. At the patient's request, they will be informed of their treatment group at the end of the study. The attending surgeon will not be blinded to the treatment group. The PI will not be blinded to the treatment group.

Background information about the patient and a pain assessment will be done at the time of enrollment by asking participants to fill out a paper questionnaire. Paper questionnaires to assess the patient's pain level will be given to and collected from patients at discharge from the hospital, the first follow up appointment (approximately 2-4 weeks postoperatively), and at the next follow up appointment (approximately 3 months postoperatively). In addition, patients will be given a paper narcotics log to enter their daily oral narcotic usage between the time of discharge and their first follow up appointment.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Local Anesthetic Use at Iliac Crest Bone Graft Site in Spinal Reconstructive Surgery
Study Start Date : April 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Bupivacaine
This group will receive bupivacaine (10ml of 0.5%) administered directly into the surgical wound at the iliac crest bone harvest site.
Drug: Bupivacaine
Single application of 10ml of bupivacaine 0.5% into the iliac crest bone harvest surgical site.
Other Name: Marcaine.

Placebo Comparator: Saline
This group will receive normal saline (10ml) administered directly into the surgical wound at the iliac crest bone harvest site.
Other: Normal Saline
Normal saline 0.9%, 10ml, single application directly into iliac crest bone harvest surgical site.




Primary Outcome Measures :
  1. Pain, Cumulative Visual Analog Score, 1st Follow Up [ Time Frame: about 4 to 5 weeks after surgery ]
    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.

  2. Pain, Cumulative Visual Analog Score, Final Follow up [ Time Frame: about 18 to 20 weeks after surgery ]
    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.


Secondary Outcome Measures :
  1. Narcotic Use, 1st Follow up [ Time Frame: about 4 to 5 weeks after surgery ]
    Number of participants using narcotics for pain

  2. Narcotic Use, Final Follow up [ Time Frame: about 18 to 20 weeks after surgery ]
    Number of participants using narcotics for pain



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087931


Locations
Layout table for location information
United States, Tennessee
Vanderbilt Medical Center
Nashville, Tennessee, United States, 37209
Sponsors and Collaborators
Vanderbilt University
Investigators
Layout table for investigator information
Principal Investigator: Kevin R O'Neill, MD, MS Vanderbilt University Medical Center, Department or Orthopaedics
Study Chair: Richard A Davis, MD Vanderbilt University Medical Center, Department or Orthopaedics
Study Chair: Clint Devin, MD Vanderbilt University Medical Center, Department or Orthopaedics
Publications of Results:
Layout table for additonal information
Responsible Party: Vanderbilt University
ClinicalTrials.gov Identifier: NCT01087931    
Other Study ID Numbers: 100096
First Posted: March 16, 2010    Key Record Dates
Results First Posted: June 25, 2018
Last Update Posted: June 25, 2018
Last Verified: May 2018
Keywords provided by Vanderbilt University Medical Center ( Vanderbilt University ):
Local anesthetic
Iliac crest bone harvest
Patients undergoing spine surgery that require use of iliac crest bone autograft
Additional relevant MeSH terms:
Layout table for MeSH terms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents