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OpenTrials
Completed

NCT Number: NCT01366196

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.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pregabalin 150 mg

Drug

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 names: Lyrica

Placebo

Drug

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.

Primary outcomes

  1. Patient Controlled Analgesia (PCA) Hydromorphone Usage

    Time frame: Postoperative day 1

Secondary outcomes

  1. Oral Analgesic Supplementation Use

    Time frame: Day of surgery

    Tabulate number of patients that used supplemental oral analgesics

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

Pregabalin for the Treatment of Pain After Posterior Spinal Fusions.

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jun 3, 2011
Registry last updated
Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.