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

This study has been withdrawn prior to enrollment.
(Several studies going on at the same time.)
Sponsor:
Information provided by (Responsible Party):
Ronald Wender, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01112878
First received: April 23, 2010
Last updated: September 10, 2015
Last verified: September 2015
  Purpose
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.

Condition Intervention Phase
Shoulder Arthroscopy
Knee Arthroscopy
Drug: Sugar pill
Drug: Gabapentin
Drug: Clonidine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Postoperative Pain using a Verbal Rating Scale (VRS) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Outcomes will be measured with follow up questionnaires at 1, 2, or 3, then 7 and 30 days after surgery


Secondary Outcome Measures:
  • Opioid consumption obtained from the recorded data [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    0= Not satisfied 100= Excellent


Enrollment: 0
Study Start Date: June 2015
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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
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.
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: 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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112878

Locations
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Ronald H Wender, MD Cedars-Sinai Medical Center
  More Information

Responsible Party: Ronald Wender, Chairman, Department of Anesthesiology, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01112878     History of Changes
Other Study ID Numbers: Pro00019373 
Study First Received: April 23, 2010
Last Updated: September 10, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Shoulder arthroscopy
Knee arthroscopy
Clonidine
Gabapentin
Pain management
Ambulatory surgery
Perioperative outcome
Analgesia

Additional relevant MeSH terms:
Gabapentin
Clonidine
Gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on July 26, 2016