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Pregabalin for the Treatment of Pain After Posterior Spinal Fusions

Pregabalin for the Treatment of Pain After Posterior Spinal Fusions.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01366196
Enrollment
86
Registered
2011-06-03
Start date
2008-10-31
Completion date
2012-02-29
Last updated
2022-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Spinal Fusions

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.

DRUGPlacebo

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

Hospital for Special Surgery, New York
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No

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

MeasureTime frame
Patient Controlled Analgesia (PCA) Hydromorphone UsagePostoperative day 1

Secondary

MeasureTime frameDescription
Oral Analgesic Supplementation UseDay of surgeryTabulate number of patients that used supplemental oral analgesics

Other

MeasureTime frameDescription
Numerical Pain Rating Scale Score on Day of SurgeryDay of SurgeryPain 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 RestPostoperative Day 1 at restPain 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 1Postoperative Day 1 with Physical TherapyPain 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

ArmCount
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
Total86

Baseline characteristics

CharacteristicControl Group (C)Pregabalin Group (P)Total
Age, Continuous56.186 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 Participants43 Participants86 Participants
Sex: Female, Male
Female
22 Participants22 Participants44 Participants
Sex: Female, Male
Male
21 Participants21 Participants42 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 430 / 43
serious
Total, serious adverse events
0 / 430 / 43

Outcome results

Primary

Patient Controlled Analgesia (PCA) Hydromorphone Usage

Time frame: Postoperative day 1

ArmMeasureValue (MEAN)Dispersion
Control Group (C)Patient Controlled Analgesia (PCA) Hydromorphone Usage44 mLStandard Deviation 12
Pregabalin Group (P)Patient Controlled Analgesia (PCA) Hydromorphone Usage39 mLStandard Deviation 9
Secondary

Oral Analgesic Supplementation Use

Tabulate number of patients that used supplemental oral analgesics

Time frame: Day of surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Control Group (C)Oral Analgesic Supplementation Use25 Participants
Pregabalin Group (P)Oral Analgesic Supplementation Use21 Participants
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Control Group (C)Numerical Pain Rating Scale Score on Day of Surgery3.8 units on a scaleStandard Deviation 2.6
Pregabalin Group (P)Numerical Pain Rating Scale Score on Day of Surgery2.9 units on a scaleStandard Deviation 2.2
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Control Group (C)Numerical Pain Rating Scale Score on Postoperative Day 1 at Rest3.7 units on a scaleStandard Deviation 2.1
Pregabalin Group (P)Numerical Pain Rating Scale Score on Postoperative Day 1 at Rest3.3 units on a scaleStandard Deviation 2.4
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Control Group (C)Numerical Pain Rating Scale Score With Physical Therapy on Postoperative Day 14.3 units on a scaleStandard Deviation 3
Pregabalin Group (P)Numerical Pain Rating Scale Score With Physical Therapy on Postoperative Day 14.5 units on a scaleStandard Deviation 3.4

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026