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

Study Overview
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Brief Summary
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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.

Official Title
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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
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Shoulder Arthroscopy, Knee Arthroscopy

Intervention / Treatment
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* Drug: Sugar pill
* Drug: Gabapentin
* Drug: Clonidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sugar Pill<br>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<br>* 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.<br>* Other names: Neurontin;Drug: Clonidine<br>* 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.<br>* Other names: Catapres;|
| Active Comparator: Clonidine<br>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<br>* 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.<br>* Other names: placebo;Drug: Gabapentin<br>* 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.<br>* Other names: Neurontin;|
| Active Comparator: Gabapentin<br>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<br>* 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.<br>* Other names: placebo;Drug: Clonidine<br>* 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.<br>* Other names: Catapres;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain using a Verbal Rating Scale (VRS) | Outcomes will be measured with follow up questionnaires at 1, 2, or 3, then 7 and 30 days after surgery | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption obtained from the recorded data | 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) | 1 month | 
| postoperative nausea and vomiting using a Verbal Rating Scale | Outcomes will be measured with follow up questionnaires at 1, 2, or 3, then 7 and 30 days after surgery | 1 month | 
| return to normal activities of daily living using follow up questionnaires | return to normal activities of daily living(including dietary intake, bowel and bladder function, physical activities) | 1 month | 
| Patient satisfaction using a verbal rating scale from 0 to 100 | 0= Not satisfied 100= Excellent | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder arthroscopy, Knee arthroscopy, Clonidine, Gabapentin, Pain management, Ambulatory surgery, Perioperative outcome, Analgesia