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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group (C) | Placebo Comparator | 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. |
|
| Pregabalin Group (P) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Controlled Analgesia (PCA) Hydromorphone Usage | Postoperative day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Oral Analgesic Supplementation Use | Tabulate number of patients that used supplemental oral analgesics | Day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day of Surgery |
| Numerical Pain Rating Scale Score on Postoperative Day 1 at Rest |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael K Urban, MD, PhD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8657426 | Background | Mao J, Price DD, Mayer DJ. Mechanisms of hyperalgesia and morphine tolerance: a current view of their possible interactions. Pain. 1995 Sep;62(3):259-274. doi: 10.1016/0304-3959(95)00073-2. | |
| 12467992 | Background | Mao J. Opioid-induced abnormal pain sensitivity: implications in clinical opioid therapy. Pain. 2002 Dec;100(3):213-217. doi: 10.1016/S0304-3959(02)00422-0. No abstract available. |
| Label | URL |
|---|---|
| This is a link to our institution's homepage. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Pregabalin Group (P) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Controlled Analgesia (PCA) Hydromorphone Usage | Posted | Mean | Standard Deviation | mL | Postoperative day 1 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Urban | Hss | (212) 606-1000 | UrbanM@hss.edu |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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|
| 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. |
|
Pain scores based on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable.
| Postoperative Day 1 at rest |
| 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. | Postoperative Day 1 with Physical Therapy |
| 16223384 | Background | Bell RF, Dahl JB, Moore RA, Kalso E. Peri-operative ketamine for acute post-operative pain: a quantitative and qualitative systematic review (Cochrane review). Acta Anaesthesiol Scand. 2005 Nov;49(10):1405-28. doi: 10.1111/j.1399-6576.2005.00814.x. |
| 7177755 | Background | Plasse M, Stahl JP, Rose-Pitet L, Joannard A, Guillen MC, Beaudoing A. [Neonatal septicemia and arthritis caused by an unusual germ]. Pediatrie. 1982 Jul-Aug;37(5):351-4. No abstract available. French. |
| 17513656 | Background | Tiippana EM, Hamunen K, Kontinen VK, Kalso E. Do surgical patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety. Anesth Analg. 2007 Jun;104(6):1545-56, table of contents. doi: 10.1213/01.ane.0000261517.27532.80. |
| 17177755 | Background | Gajraj NM. Pregabalin for pain management. Pain Pract. 2005 Jun;5(2):95-102. doi: 10.1111/j.1533-2500.2005.05205.x. |
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Oral Analgesic Supplementation Use | Tabulate number of patients that used supplemental oral analgesics | Posted | Count of Participants | Participants | Day of surgery |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Day of Surgery |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Postoperative Day 1 at rest |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Postoperative Day 1 with Physical Therapy |
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | 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. 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. | 0 | 43 | 0 | 43 |
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |