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Pregabalin for the Treatment of Pain After Posterior Spinal Fusions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01366196
First received: June 2, 2011
Last updated: May 22, 2017
Last verified: May 2017
  Purpose

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 Intervention
Lumbar Spinal Fusions Drug: Pregabalin 150 mg Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Pregabalin for the Treatment of Pain After Posterior Spinal Fusions.

Resource links provided by NLM:


Further study details as provided by Hospital for Special Surgery, New York:

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

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


Enrollment: 86
Study Start Date: October 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01366196     History of Changes
Other Study ID Numbers: IRB #27092
Study First Received: June 2, 2011
Results First Received: March 23, 2017
Last Updated: May 22, 2017

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:
Molecular Mechanisms of Pharmacological Action
Pregabalin
Peripheral Nervous System Agents
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

ClinicalTrials.gov processed this record on June 23, 2017