NCT01112878WithdrawnPhase 4
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Cedars-Sinai Medical Center
- Locations
- 1
- Primary Endpoint
- Postoperative Pain using a Verbal Rating Scale (VRS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Sugar Pill
Placebo Comparator
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.
Intervention: Gabapentin (Drug)
Sugar Pill
Placebo Comparator
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.
Intervention: Clonidine (Drug)
Clonidine
Active Comparator
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.
Intervention: Sugar pill (Drug)
Clonidine
Active Comparator
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.
Intervention: Gabapentin (Drug)
Gabapentin
Active Comparator
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.
Intervention: Sugar pill (Drug)
Gabapentin
Active Comparator
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.
Intervention: Clonidine (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- return to normal activities of daily living using follow up questionnaires(1 month)
- Patient satisfaction using a verbal rating scale from 0 to 100(1 month)
- Opioid consumption obtained from the recorded data(1 month)
- postoperative nausea and vomiting using a Verbal Rating Scale(1 month)
Investigators
Ronald Wender
Chairman, Department of Anesthesiology
Cedars-Sinai Medical Center
Study Sites (1)
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