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Pregabalin for the Treatment of Pain After Posterior Spinal Fusions

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ClinicalTrials.gov Identifier: NCT01366196
Recruitment Status : Completed
First Posted : June 3, 2011
Results First Posted : June 21, 2017
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

June 2, 2011
June 3, 2011
March 23, 2017
June 21, 2017
March 30, 2018
October 2008
February 2012   (Final data collection date for primary outcome measure)
Patient Controlled Analgesia (PCA) Hydromorphone Usage [ Time Frame: Postoperative day 1 ]
Pain Scores [ Time Frame: Up to 14 days after day of surgery. ]
We will record patients' pain scores (on scale of 0-10) while at rest, during activity (e.g. physical therapy) and with narcotic use for up to 14 days following the day of surgery. We anticipate that patients who receive pregabalin will have reduced pain scores.
Complete list of historical versions of study NCT01366196 on ClinicalTrials.gov Archive Site
Oral Analgesic Supplementation Use [ Time Frame: Day of surgery ]
Tabulate number of patients that used supplemental oral analgesics
  • Opioid Related Side Effects [ Time Frame: Up to 14 days after day of surgery ]
    We will record all incidences of opioid related side effects (e.g. postoperative nausea and vomiting, pruitis), if any, following the day of surgery.
  • Length of Hospital Stay [ Time Frame: On average, up to 5 days following surgery. ]
    We will record the length of hospital stay following surgery.
  • Opioid Consumption [ Time Frame: Up to 14 days following surgery ]
    We will tabulate narcotic use throughout patients' hospital and up to 14 days following surgery.
  • Numerical Pain Rating Scale Score on Day of Surgery [ Time Frame: Day of Surgery ]
    Pain scores based on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable.
  • Numerical Pain Rating Scale Score on Postoperative Day 1 at Rest [ Time Frame: Postoperative Day 1 at rest ]
    Pain scores based on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable.
  • Numerical Pain Rating Scale Score With Physical Therapy on Postoperative Day 1 [ Time Frame: Postoperative Day 1 with Physical Therapy ]
    Pain scores based on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable.
Not Provided
 
Pregabalin for the Treatment of Pain After Posterior Spinal Fusions
Pregabalin for the Treatment of Pain After Posterior Spinal Fusions.

Acute pain management is challenging in patients after spinal fusions, particularly since most have taken analgesics for prolonged periods before choosing the surgical alternative. Many of these patients are either preoperatively or become after surgery narcotic dependent. In addition, the narcotic based anesthetic required for the procedure, may induce a postoperative hyper-analgesia which may be partially responsible for the acute postoperative pain which is refractory to traditional doses of narcotics. Both the persistent nociceptive and neuropathic pain which these patients experience and narcotic-induced hyper-analgesia is mediated via non-conventional neural pathways. It is for these reasons, that in these patients postoperative pain is refractory to narcotic treatment. Postoperative pain in this situation is best managed using a multimodal approach. This technique allows the application of a number of treatment modalities which maximize pain reduction and minimize treatment side effects.

Pregabalin (Lyrica) has been shown to be effective in the treatment of neuropathic pain. Pregabalin has a similar mechanism of action as gabapentin. Notably it has a rapid consistent absorption, linear pharmacokinetics, and a low potential for pharmacokinetic drug interactions. Hence, pregabalin should be a beneficial addition to the multi-modal pain regimen after spinal surgery; particularly in narcotic tolerant patients who respond poorly to conventional narcotic analgesics after surgery.

The treatment of postoperative pain continues to be a challenge, particularly after posterior spinal fusions. Many of these patients have been treated with analgesics or other modalities for prolonged periods before choosing the surgical alternative. In addition, the narcotic-based anesthetic required for the procedure may induce postoperative hyper-analgesia. Inadequate treatment of this pain can result in prolonged hospitalization, cardiopulmonary complications, and poor surgical outcome. However, the narcotic treatment of pain is often associated with multiple adverse effects. Multimodal postoperative analgesia has been instituted to reduce pain while limiting the adverse side effects of opioids. Pregabalin has been shown to be efficacious in the management of chronic pain syndromes with limited adverse side effects. Hence, multiple studies have attempted to demonstrate the benefits of including pregabalin in multimodal postoperative pain management. These studies have yielded conflicting results with regard to reduced pain, opioid consumption, and improved outcome. We propose that the addition of pregabalin to acute pain regimen after posterior spinal fusions should reduce narcotic requirements and hence improve outcome by reducing narcoticinduced side effects. Although recent studies have also examined the administration of pregabalin after spinal fusions, this study was conducted with a uniform anesthetic regimen and similar procedure performed by two spine surgeons at one institution. Pain scores were controlled as well as physical therapy milestones to assess whether changes in the pain regimen would affect narcotic consumption, narcotic induced side effects, and length of hospitalization.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Lumbar Spinal Fusions
  • Drug: Pregabalin 150 mg
    Patients will receive two 75 mg capsules of pregabalin 1 hour before surgery. They continue to take 2 capsules of 75 mg (total 150 mg) until POD 14.
    Other Name: Lyrica
  • Drug: Placebo
    Patients will first receive two capsules of the placebo drug (with no active ingredients per dose) one hour before surgery. Patients will continue taking two capsules per day until POD 14.
  • Placebo Comparator: Control Group (C)
    Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.
    Intervention: Drug: Placebo
  • Experimental: Pregabalin Group (P)
    Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.
    Intervention: Drug: Pregabalin 150 mg

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
80
February 2012
February 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients for elective lumber posterior spinal fusions with segmental instrumentation

Exclusion Criteria:

  • Use of pregabalin or gabapentin within the washout period. Some chronic pain patients should not be subjected to a washout period for either medication prior to surgery, as determined by their pain management physician, and these patients will be excluded from the study.
  • Allergic sensitivity to pregabalin.
  • Renal insufficiency, Cr ≥ 1.5 mg/dl.
  • Active substance abuse.
  • Unstable mental condition.
  • Non English Speaking Patients.
Sexes Eligible for Study: All
21 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01366196
IRB #27092
No
Not Provided
Not Provided
Hospital for Special Surgery, New York
Hospital for Special Surgery, New York
Not Provided
Principal Investigator: Michael K Urban, MD, PhD Hospital for Special Surgery, New York
Hospital for Special Surgery, New York
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP