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
Summary
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 datapostoperative 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
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
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
|