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Clinical Trial of Gabapentin to Decrease Postoperative Delirium and Pain

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ClinicalTrials.gov Identifier: NCT00221338
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : September 10, 2020
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This will be a double blind, placebo-controlled study of patients ≥65 years of age undergoing surgery of the spine, hips and knees replacement at the University of California, San Francisco (UCSF) Medical Center. Intraoperative anesthetic and postoperative pain management will be standardized. Patients will be randomized to receive either placebo or gabapentin preoperatively, and continued postoperatively until discharge. Intraoperative anesthetic and other postoperative pain management strategies will be standardized. Postoperative delirium will be measured using structured interviews. Cognitive function will be measured using a battery of neurocognitive tests pre- and post-operatively. Using an intention to treat strategy, we, the researchers at UCSF, will compare the incidence of postoperative delirium and cognitive dysfunction, the amount of postoperative pain, and narcotic requirements between the two groups. The primary outcome will be postoperative delirium. Secondary outcomes will be postoperative pain and opioids use, and length of hospital stay, and cognitive dysfunction.

Condition or disease Intervention/treatment Phase
Postoperative Delirium Postoperative Pain Opioid Use Hospital Length of Stay Drug: Gabapentin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial of Gabapentin to Decrease Postoperative Delirium and Pain in Surgical Patients
Study Start Date : January 2006
Actual Primary Completion Date : January 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Experimental: Gabapentin
Double blind, placebo controlled
Drug: Gabapentin
This is a Double blind, placebo-controlled experimental study in which gabapentin adjusted for renal clearance (or placebo) is given preoperatively and also the first three postoperative days
Other Name: gabapentin versus placebo

Placebo Comparator: Placebo
Double blind
Drug: Gabapentin
This is a Double blind, placebo-controlled experimental study in which gabapentin adjusted for renal clearance (or placebo) is given preoperatively and also the first three postoperative days
Other Name: gabapentin versus placebo




Primary Outcome Measures :
  1. Incidence of Postoperative Delirium by Study Group [ Time Frame: postoperative days 1, 2 and 3 ]
    Number of subjects who developed postoperative delirium, as measured by the Confusion Assessment Method, a validated tool for assessing delirium based on DSM-III-R, on any of the first three postoperative days.


Secondary Outcome Measures :
  1. Median Postoperative Opioid Doses Across Study Follow up Period [ Time Frame: Study follow up period: postoperative days 1, 2 and 3 ]
    Postoperative intravenous opioid doses converted to morphine equivalents. Median derived from total opioid doses on first, second and third postoperative days.

  2. Hospital Length of Stay [ Time Frame: Typically within the first week after surgery ]
  3. Postoperative Pain Score - Postoperative Day 1 [ Time Frame: Postoperative day 1 ]
    Postoperative pain as measured by Visual Analog Pain scale (0=no pain, 10=worst pain imaginable).

  4. Postoperative Pain Score - Postoperative Day 2 [ Time Frame: Postoperative day 2 ]
    Postoperative pain as measured by Visual Analog Pain scale (0=no pain, 10=worst pain imaginable).

  5. Postoperative Pain Score - Postoperative Day 3 [ Time Frame: Postoperative day 3 ]
    Postoperative pain as measured by Visual Analog Pain scale (0=no pain, 10=worst pain imaginable).



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female ≥65 years of age undergoing surgery involving the spine, hip or knee replacement.
  • English speaking.
  • Anticipated to stay in the hospital for at least 48 hours.

Exclusion Criteria:

  • Patients who take gabapentin preoperatively, or have known sensitivity to the drug, or those unable to be randomized to receive gabapentin.
  • Subjects who are unable to provide informed consent.
  • Patients with a history of narcotic tolerance.
  • Patients with planned two stage spinal procedures (anterior-posterior spinal fusion to be done on two separate days).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00221338


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143-0648
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Jacqueline M Leung, MD, MPH University of California, San Francisco, CA, USA
Publications of Results:
Other Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00221338    
Other Study ID Numbers: H5636-26795-01
First Posted: September 22, 2005    Key Record Dates
Results First Posted: September 10, 2020
Last Update Posted: September 10, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Plan to share undecided
Keywords provided by University of California, San Francisco:
gabapentin
pain
surgery
delirium
cognitive decline
Additional relevant MeSH terms:
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Delirium
Neurologic Manifestations
Confusion
Neurobehavioral Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents