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

Information source: Cedars-Sinai Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Shoulder Arthroscopy; Knee Arthroscopy

Intervention: Sugar pill (Drug); Gabapentin (Drug); Clonidine (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Cedars-Sinai Medical Center

Official(s) and/or principal investigator(s):
Ronald H Wender, MD, Principal Investigator, Affiliation: Cedars-Sinai Medical Center

Overall contact:
Paul F White, Md, PhD, Phone: (214) 648-6424, Email: paul.white@utsouthwestern.edu


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Primary outcome: Postoperative Pain using a Verbal Rating Scale (VRS)

Secondary outcome:

Opioid consumption obtained from the recorded data

postoperative nausea and vomiting using a Verbal Rating Scale

return to normal activities of daily living using follow up questionnaires

Patient satisfaction using a verbal rating scale from 0 to 100


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


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

Locations and Contacts

Paul F White, Md, PhD, Phone: (214) 648-6424, Email: paul.white@utsouthwestern.edu

Cedars Sinai Medical Center, Los Angeles, California 90048, United States; Enrolling by invitation
Additional Information

Starting date: June 2015
Last updated: February 26, 2015

Page last updated: August 20, 2015

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