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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

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Lumbar Spinal Fusions Drug: Pregabalin 150 mg Drug: Placebo Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pregabalin for the Treatment of Pain After Posterior Spinal Fusions.
Study Start Date : October 2008
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin
U.S. FDA Resources

Arm Intervention/treatment
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.
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.
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.
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



Primary Outcome Measures :
  1. Patient Controlled Analgesia (PCA) Hydromorphone Usage [ Time Frame: Postoperative day 1 ]

Secondary Outcome Measures :
  1. Oral Analgesic Supplementation Use [ Time Frame: Day of surgery ]
    Tabulate number of patients that used supplemental oral analgesics


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT01366196


Locations
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Principal Investigator: Michael K Urban, MD, PhD Hospital for Special Surgery, New York

Additional Information:
Publications:
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01366196     History of Changes
Other Study ID Numbers: IRB #27092
First Posted: June 3, 2011    Key Record Dates
Results First Posted: June 21, 2017
Last Update Posted: March 30, 2018
Last Verified: March 2018

Keywords provided by Hospital for Special Surgery, New York:
Orthopedic Procedures
Spinal Fusions
Pregabalin
Gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Additional relevant MeSH terms:
Pregabalin
Peripheral Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs