Pregabalin for the Treatment of Pain After Posterior Spinal Fusions
|ClinicalTrials.gov Identifier: NCT01366196|
Recruitment Status : Completed
First Posted : June 3, 2011
Results First Posted : June 21, 2017
Last Update Posted : March 30, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Lumbar Spinal Fusions||Drug: Pregabalin 150 mg Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Pregabalin for the Treatment of Pain After Posterior Spinal Fusions.|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
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.
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.
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
- Patient Controlled Analgesia (PCA) Hydromorphone Usage [ Time Frame: Postoperative day 1 ]
- Oral Analgesic Supplementation Use [ Time Frame: Day of surgery ]Tabulate number of patients that used supplemental oral analgesics
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366196
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|Principal Investigator:||Michael K Urban, MD, PhD||Hospital for Special Surgery, New York|