Pregabalin for the Treatment of Pain After Posterior Spinal Fusions

NCT01366196 | Completed Results

• 1 other identifier: 2012-043
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Patient Controlled Analgesia (PCA) Hydromorphone Usage

  Postoperative day 1

Secondary Outcomes (1)

• Oral Analgesic Supplementation Use

  Day of surgery

Other Outcomes (3)

• Numerical Pain Rating Scale Score on Day of Surgery

  Day of Surgery

• Numerical Pain Rating Scale Score on Postoperative Day 1 at Rest

  Postoperative Day 1 at rest

• Numerical Pain Rating Scale Score With Physical Therapy on Postoperative Day 1

  Postoperative Day 1 with Physical Therapy

Study Arms (2)

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.

Drug: Placebo

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.

Drug: Pregabalin 150 mg

Interventions

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.

Also known as: Lyrica

Pregabalin Group (P)

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.

Control Group (C)

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients for elective lumber posterior spinal fusions with segmental instrumentation

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (6)

• 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.

  PMID: 8657426 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.

  PMID: 12467992 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.

  PMID: 16223384 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.

  PMID: 7177755 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.

  PMID: 17513656 BACKGROUND

• Gajraj NM. Pregabalin for pain management. Pain Pract. 2005 Jun;5(2):95-102. doi: 10.1111/j.1533-2500.2005.05205.x.

  PMID: 17177755 BACKGROUND

Related Links

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MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Michael Urban
• Organization: Hss

UrbanM@hss.edu

(212) 606-1000

Study Officials

• Michael K Urban, MD, PhD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2011
• First Posted: June 3, 2011
• Study Start: October 1, 2008
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 14, 2022
• Results First Posted: June 21, 2017

Record last verified: 2022-04

Locations

US (1)