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Oral Clonidine & Gabapentin: Improving Recovery and Pain Management After Outpatient With Major Orthopedic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01112878
Recruitment Status : Withdrawn (Several studies going on at the same time.)
First Posted : April 29, 2010
Last Update Posted : September 14, 2015
Sponsor:
Information provided by (Responsible Party):

April 23, 2010
April 29, 2010
September 14, 2015
June 2015
June 2015   (Final data collection date for primary outcome measure)
Postoperative Pain using a Verbal Rating Scale (VRS) [ Time Frame: 1 month ]
Outcomes will be measured with follow up questionnaires at 1, 2, or 3, then 7 and 30 days after surgery
Same as current
Complete list of historical versions of study NCT01112878 on ClinicalTrials.gov Archive Site
  • Opioid consumption obtained from the recorded data [ Time Frame: 1 month ]
    Perioperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts) Post discharge use of opioid consumption (data obtained from the follow up questionnaires at 1, 2, or 3, then 7 and 30 days after surgery)
  • postoperative nausea and vomiting using a Verbal Rating Scale [ Time Frame: 1 month ]
    Outcomes will be measured with follow up questionnaires at 1, 2, or 3, then 7 and 30 days after surgery
  • return to normal activities of daily living using follow up questionnaires [ Time Frame: 1 month ]
    return to normal activities of daily living(including dietary intake, bowel and bladder function, physical activities)
  • Patient satisfaction using a verbal rating scale from 0 to 100 [ Time Frame: 1 month ]
    0= Not satisfied 100= Excellent
Same as current
Not Provided
Not Provided
 
Oral Clonidine & Gabapentin: Improving Recovery and Pain Management After Outpatient With Major Orthopedic Surgery
Randomized, Double-Blinded, Placebo-controlled Study to Evaluate the Analgesic Efficacy of Oral Clonidine and Gabapentin as Part of a Multi-modal Analgesic Regimen for Preventing Pain After Arthroscopic Shoulder or Knee Surgery
The purpose of this research is to investigate the non-opioid (non-narcotic) pain-relieving medications clonidine and gabapentin to see if they decrease the amount of opioid pain medications needed after surgery, thereby reducing opioid-related side effects, and time required to return to normal activities of daily living after surgery.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
  • Shoulder Arthroscopy
  • Knee Arthroscopy
  • Drug: 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.
    Other Name: placebo
  • Drug: 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.
    Other Name: Neurontin
  • Drug: 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 Name: Catapres
  • Placebo Comparator: 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.
    Interventions:
    • Drug: Gabapentin
    • Drug: Clonidine
  • Active Comparator: 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.
    Interventions:
    • Drug: Sugar pill
    • Drug: Gabapentin
  • Active Comparator: 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.
    Interventions:
    • Drug: Sugar pill
    • Drug: Clonidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
June 2015
June 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients scheduled to undergo arthroscopic joint surgery
  • 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 known allergy, hypersensitivity or contraindications to clonidine, gabapentin, anesthetic or analgesic medications
  • 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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01112878
Pro00019373
Yes
Not Provided
Not Provided
Ronald Wender, Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
Not Provided
Principal Investigator: Ronald H Wender, MD Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP