Lumbar Spinal Fusions
Conditions
Keywords
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
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.
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.
Interventions
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.
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.
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient Controlled Analgesia (PCA) Hydromorphone Usage | Postoperative day 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oral Analgesic Supplementation Use | Day of surgery | Tabulate number of patients that used supplemental oral analgesics |
Other
| Measure | Time frame | Description |
|---|---|---|
| Numerical Pain Rating Scale Score on Day of Surgery | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 43 |
| 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. | 43 |
| Total | 86 |
Baseline characteristics
| Characteristic | Control Group (C) | Pregabalin Group (P) | Total |
|---|---|---|---|
| Age, Continuous | 56.186 years STANDARD_DEVIATION 12.599 | 57.511 years STANDARD_DEVIATION 13.491 | 56.849 years STANDARD_DEVIATION 12.993 |
| Region of Enrollment United States | 43 Participants | 43 Participants | 86 Participants |
| Sex: Female, Male Female | 22 Participants | 22 Participants | 44 Participants |
| Sex: Female, Male Male | 21 Participants | 21 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 43 | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 | 0 / 43 |
Outcome results
Patient Controlled Analgesia (PCA) Hydromorphone Usage
Time frame: Postoperative day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group (C) | Patient Controlled Analgesia (PCA) Hydromorphone Usage | 44 mL | Standard Deviation 12 |
| Pregabalin Group (P) | Patient Controlled Analgesia (PCA) Hydromorphone Usage | 39 mL | Standard Deviation 9 |
Oral Analgesic Supplementation Use
Tabulate number of patients that used supplemental oral analgesics
Time frame: Day of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group (C) | Oral Analgesic Supplementation Use | 25 Participants |
| Pregabalin Group (P) | Oral Analgesic Supplementation Use | 21 Participants |
Numerical Pain Rating Scale Score on 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.
Time frame: Day of Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group (C) | Numerical Pain Rating Scale Score on Day of Surgery | 3.8 units on a scale | Standard Deviation 2.6 |
| Pregabalin Group (P) | Numerical Pain Rating Scale Score on Day of Surgery | 2.9 units on a scale | Standard Deviation 2.2 |
Numerical Pain Rating Scale Score on 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.
Time frame: Postoperative Day 1 at rest
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group (C) | Numerical Pain Rating Scale Score on Postoperative Day 1 at Rest | 3.7 units on a scale | Standard Deviation 2.1 |
| Pregabalin Group (P) | Numerical Pain Rating Scale Score on Postoperative Day 1 at Rest | 3.3 units on a scale | Standard Deviation 2.4 |
Numerical Pain Rating Scale Score With Physical Therapy on Postoperative Day 1
Pain scores based on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable.
Time frame: Postoperative Day 1 with Physical Therapy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group (C) | Numerical Pain Rating Scale Score With Physical Therapy on Postoperative Day 1 | 4.3 units on a scale | Standard Deviation 3 |
| Pregabalin Group (P) | Numerical Pain Rating Scale Score With Physical Therapy on Postoperative Day 1 | 4.5 units on a scale | Standard Deviation 3.4 |