Pain Relief at Iliac Crest Bone Harvest Sites in Spine Surgery Using Bupivacaine
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/27/2018 |
| Start Date: | April 2010 |
| End Date: | October 2011 |
Local Anesthetic Use at Iliac Crest Bone Graft Site in Spinal Reconstructive Surgery
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.
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.
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.
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.
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.
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