Pain Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled Trial to Assess the Safety and Efficacy of the Perioperative Administration of Pregabalin in Reducing the Incidence of Postoperative Delirium and Improving Acute Postoperative Pain Management
Verified date | January 2012 |
Source | Ottawa Hospital Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether administration of pregabalin by mouth immediately preoperatively and three times daily for 3 days after surgery reduces the incidence of delirium postoperatively and improves overall pain control.
Status | Completed |
Enrollment | 240 |
Est. completion date | October 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - aged 60 years and older - booked for major orthopaedic or vascular procedure - expected length of stay > 2 days Exclusion Criteria: - open AAA repair - EVAR - allergy/sensitivity to pregabalin or gabapentin - use of pregabalin or gabapentin in previous 14 days - severe liver disease - severe renal dysfunction defined as either having creatinine clearance < 30 ml/min or being dialysis-dependent - seizure disorder - MMSE < 24/30 - inability to speak English or French |
Country | Name | City | State |
---|---|---|---|
Canada | The Ottawa Hospital | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute | Pfizer |
Canada,
Bekker AY, Weeks EJ. Cognitive function after anaesthesia in the elderly. Best Pract Res Clin Anaesthesiol. 2003 Jun;17(2):259-72. Review. — View Citation
Bitsch M, Foss N, Kristensen B, Kehlet H. Pathogenesis of and management strategies for postoperative delirium after hip fracture: a review. Acta Orthop Scand. 2004 Aug;75(4):378-89. Review. — View Citation
Gilron I. Review article: the role of anticonvulsant drugs in postoperative pain management: a bench-to-bedside perspective. Can J Anaesth. 2006 Jun;53(6):562-71. Review. — View Citation
Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. — View Citation
Leung JM, Sands LP, Rico M, Petersen KL, Rowbotham MC, Dahl JB, Ames C, Chou D, Weinstein P. Pilot clinical trial of gabapentin to decrease postoperative delirium in older patients. Neurology. 2006 Oct 10;67(7):1251-3. Epub 2006 Aug 16. — View Citation
Lynch EP, Lazor MA, Gellis JE, Orav J, Goldman L, Marcantonio ER. The impact of postoperative pain on the development of postoperative delirium. Anesth Analg. 1998 Apr;86(4):781-5. — View Citation
Morrison RS, Magaziner J, Gilbert M, Koval KJ, McLaughlin MA, Orosz G, Strauss E, Siu AL. Relationship between pain and opioid analgesics on the development of delirium following hip fracture. J Gerontol A Biol Sci Med Sci. 2003 Jan;58(1):76-81. — View Citation
Peng PW, Wijeysundera DN, Li CC. Use of gabapentin for perioperative pain control -- a meta-analysis. Pain Res Manag. 2007 Summer;12(2):85-92. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Delirium (patient is either CAM-ICU positive or positive for delirium by chart review) | postoperative day 1, 2, 3 | ||
Secondary | Interference with daily activities using BPI | postoperative day 3 | ||
Secondary | Pain at rest using NRS | postoperative days 1, 2, 3 | ||
Secondary | Pain with movement of the operative site using NRS | postoperative days 1, 2, 3 | ||
Secondary | Narcotic analgesic requirements | postoperative days 0, 1, 2, 3 | ||
Secondary | Sedation using RSS | postoperative days 1, 2, 3 | ||
Secondary | Narcotic-related adverse effects using ORSDS | postoperative days 1, 2, 3 | ||
Secondary | Recovery using the QoR | postoperative day 3 | ||
Secondary | Length of stay | Discharge day | ||
Secondary | Medical Outcome Study (MOS) sleep score | Postoperative day 3 |
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