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Shoulder Arthroscopy |

Shoulder Arthroscopy research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Shoulder Arthroscopy

Knee Arthroscopy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Sugar pillDosage 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.

Drug:GabapentinDosage 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.

Drug:ClonidineDosage 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Sugar PillFrequency 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.

ClonidineDosage: 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.

GabapentinDosage: 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.

Study Status

Withdrawn

Start Date: June 2015

Completed Date: June 2015

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Postoperative Pain using a Verbal Rating Scale (VRS)

Secondary Outcome: Opioid consumption obtained from the recorded data

Study sponsors, principal investigator, and references

Principal Investigator: Ronald H Wender, MD

Lead Sponsor: Cedars-Sinai Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01112878

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