Pain Relief at Iliac Crest Bone Harvest Sites in Spine Surgery Using Bupivacaine
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|ClinicalTrials.gov Identifier: NCT01087931|
Recruitment Status : Completed
First Posted : March 16, 2010
Results First Posted : June 25, 2018
Last Update Posted : June 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Bupivacaine Other: Normal Saline||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
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.
- 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.
- 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.
- Narcotic Use, 1st Follow up [ Time Frame: about 4 to 5 weeks after surgery ]Number of participants using narcotics for pain
- Narcotic Use, Final Follow up [ Time Frame: about 18 to 20 weeks after surgery ]Number of participants using narcotics for pain
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
|United States, Tennessee|
|Vanderbilt Medical Center|
|Nashville, Tennessee, United States, 37209|
|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|