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Phase 3 N=750 Randomized Quadruple-blind Treatment

Clinical Trial of Gabapentin to Decrease Postoperative Delirium and Pain

Postoperative Delirium · Postoperative Pain · Opioid Use · Hospital Length of Stay

Enrolled (actual)
750
Serious AEs
10.8%
Results posted
Sep 2020
Primary outcome: Primary: Incidence of Postoperative Delirium by Study Group — 84; 72 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Gabapentin (Drug)
Age
Older Adult · 65+ yrs
Sex
All
Sponsor
University of California, San Francisco
Primary completion
Jan 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Incidence of Postoperative Delirium by Study Group
84; 72
SECONDARY
Median Postoperative Opioid Doses Across Study Follow up Period
6.7; 6.7
SECONDARY
Hospital Length of Stay
4.4; 4.1
SECONDARY
Postoperative Pain Score - Postoperative Day 1
4; 4
SECONDARY
Postoperative Pain Score - Postoperative Day 2
3; 4
SECONDARY
Postoperative Pain Score - Postoperative Day 3
3; 3

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.

Eligibility 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).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00221338). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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