Knee Arthroscopy, Shoulder Arthroscopy
Conditions
Keywords
Shoulder arthroscopy, Knee arthroscopy, Clonidine, Gabapentin, Pain management, Ambulatory surgery, Perioperative outcome, Analgesia
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.
Interventions
DRUGSugar pill
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.
DRUGGabapentin
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.
DRUGClonidine
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.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain using a Verbal Rating Scale (VRS) | 1 month | Outcomes will be measured with follow up questionnaires at 1, 2, or 3, then 7 and 30 days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption obtained from the recorded data | 1 month | 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) |
| postoperative nausea and vomiting using a Verbal Rating Scale | 1 month | Outcomes will be measured with follow up questionnaires at 1, 2, or 3, then 7 and 30 days after surgery |
| return to normal activities of daily living using follow up questionnaires | 1 month | return to normal activities of daily living(including dietary intake, bowel and bladder function, physical activities) |
| Patient satisfaction using a verbal rating scale from 0 to 100 | 1 month | 0= Not satisfied 100= Excellent |
Countries
United States
Outcome results
None listed