Pregabalin for the Treatment of Pain After Posterior Spinal Fusions

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01366196
First received: June 2, 2011
Last updated: July 23, 2012
Last verified: June 2011
  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.

Hypothesis: Patients treated with Pregabalin after posterior-spinal fusions will have: 1) reduced pain at rest and with physical therapy, and 2) reduced narcotic requirements with fewer narcotic related side-effects than controls treated with Pregabalin. This may result in a shorter hospital stay (the mean length of stay for 1-2 level posterior lumbar-sacral fusions with instrumentation at our institution is 4.9±2 days).


Condition Intervention Phase
Lumbar Spinal Fusions
Drug: Pregabalin 150 mg
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:
  • Pain Scores [ Time Frame: Up to 14 days after day of surgery. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Opioid Related Side Effects [ Time Frame: Up to 14 days after day of surgery ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    We will record the length of hospital stay following surgery.

  • Opioid Consumption [ Time Frame: Up to 14 days following surgery ] [ Designated as safety issue: No ]
    We will tabulate narcotic use throughout patients' hospital and up to 14 days following surgery.


Enrollment: 90
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.

Postoperative pain will be assessed daily until discharge using a verbal Numerical Rating Scale (NRS) at rest and during physical therapy, by both physical therapists and blinded research assistants.

All narcotics (i.v. PCA, oral or IM/SQ rescue doses) will be tabulated during their hospital stay, and patients will be asked to document their oral narcotic use after discharge.

On the day of discharge, patients will be given a self report data sheet, in which they will be asked to record their daily pain level at rest, with movement, and whether their pain interfered with sleep.

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.

Postoperative pain will be assessed daily until discharge using a verbal Numerical Rating Scale (NRS) at rest and during physical therapy, by both physical therapists and blinded research assistants.

All narcotics (i.v. PCA, oral or IM/SQ rescue doses) will be tabulated during their hospital stay, and patients will be asked to document their oral narcotic use after discharge.

On the day of discharge, patients will be given a self report data sheet, in which they will be asked to record their daily pain level at rest, with movement, and whether their pain interfered with sleep.

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
Genders Eligible for Study:   Both
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
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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
Pfizer
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
Last Updated: July 23, 2012
Health Authority: United States: Institutional Review Board

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
Peripheral Nervous System Agents
Pregabalin
Pharmacologic Actions
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 20, 2014