Oral Clonidine & Gabapentin: Improving Recovery and Pain Management After Outpatient With Major Orthopedic Surgery
NCT ID: NCT01112878
Last Updated: 2015-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2015-06-30
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
DOUBLE
Study Groups
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Sugar Pill
Frequency and Dosage:
* once in the preoperative holding area and once before discharge from PACU
* continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery.
Gabapentin
Dosage form: capsule, by mouth
Dosage: 600 mg
Frequency and duration:
* once in the preoperative holding area and once before discharge from PACU
* continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery.
Clonidine
Dosage form: capsule, by mouth
Dosage: 0.2 mg
Frequency and duration:
* once in the preoperative holding area and once before discharge from PACU
* continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery.
Clonidine
Dosage: 0.2 mg
* once in the preoperative holding area and once before discharge from PACU
* continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery.
Sugar pill
Dosage form: capsule, by mouth
Dosage: not applicable
Frequency and Dosage:
* once in the preoperative holding area and once before discharge from PACU
* continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery.
Gabapentin
Dosage form: capsule, by mouth
Dosage: 600 mg
Frequency and duration:
* once in the preoperative holding area and once before discharge from PACU
* continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery.
Gabapentin
Dosage: 600 mg
* once in the preoperative holding area and once before discharge from PACU
* continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery.
Sugar pill
Dosage form: capsule, by mouth
Dosage: not applicable
Frequency and Dosage:
* once in the preoperative holding area and once before discharge from PACU
* continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery.
Clonidine
Dosage form: capsule, by mouth
Dosage: 0.2 mg
Frequency and duration:
* once in the preoperative holding area and once before discharge from PACU
* continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery.
Interventions
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Sugar pill
Dosage form: capsule, by mouth
Dosage: not applicable
Frequency and Dosage:
* once in the preoperative holding area and once before discharge from PACU
* continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery.
Gabapentin
Dosage form: capsule, by mouth
Dosage: 600 mg
Frequency and duration:
* once in the preoperative holding area and once before discharge from PACU
* continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery.
Clonidine
Dosage form: capsule, by mouth
Dosage: 0.2 mg
Frequency and duration:
* once in the preoperative holding area and once before discharge from PACU
* continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willingness and ability to sign an informed consent document
* No allergies to clonidine, gabapentin, anesthetic or analgesic medications
* 18 - 80 years of age
* American Society of Anesthesiologists (ASA) Class I - III adults of either sex
* Women of childbearing potential must be currently practicing an acceptable form of birth control, and have a negative urine pregnancy test
Exclusion Criteria
* Patients with clinically-significant medical conditions, such as brain, heart, kidney, endocrine, or liver diseases, peptic ulcer disease or bleeding disorders
* Patients with chronic hypertension or pain syndromes receiving clonidine or gabapentin, respectively.
* Pregnant or lactating women
* Subjects with a history of alcohol or drug abuse within the past 3 months
* Patients taking any analgesic medications within 48 hours prior to the surgery
* Any other conditions or use of any medication which may interfere with the conduct of the study
* Non-English speakers
* Patients greater than 80 years of age
18 Years
80 Years
ALL
No
Sponsors
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Cedars-Sinai Medical Center
OTHER
Responsible Party
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Ronald Wender
Chairman, Department of Anesthesiology
Principal Investigators
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Ronald H Wender, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Cedars Sinai Medical Center
Los Angeles, California, United States
Countries
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Other Identifiers
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Pro00019373
Identifier Type: -
Identifier Source: org_study_id
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