Clinical trial NCT01112878: Oral Clonidine & Gabapentin: Improving Recovery and Pain Management After Outpatient With Major Orthopedic Surgery
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Shoulder Arthroscopy
Knee Arthroscopy
Keywords: Shoulder arthroscopy
Knee arthroscopy
Clonidine
Gabapentin
Pain management
Ambulatory surgery
Perioperative outcome
Analgesia
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2010-04-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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

Primary outcomes:
measure: Postoperative Pain using a Verbal Rating Scale (VRS)
timeFrame: 1 month
Secondary outcomes:
measure: Opioid consumption obtained from the recorded data
timeFrame: 1 month
measure: postoperative nausea and vomiting using a Verbal Rating Scale
timeFrame: 1 month
measure: return to normal activities of daily living using follow up questionnaires
timeFrame: 1 month
measure: Patient satisfaction using a verbal rating scale from 0 to 100
timeFrame: 1 month
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Ronald H Wender, MD
role: PRINCIPAL_INVESTIGATOR
References: