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

Cedars-Sinai Medical Center

Status and phase: Withdrawn; Phase 4

Conditions: Shoulder Arthroscopy; Knee Arthroscopy

Treatments: Drug: Clonidine; Drug: Sugar pill; Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT01112878

Pro00019373

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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0 participants in 3 patient groups, including a placebo group

Sugar Pill

Placebo Comparator group

Description:

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.

Treatment:

Drug: Gabapentin

Drug: Clonidine

Clonidine

Active Comparator group

Description:

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.

Treatment:

Drug: Gabapentin

Drug: Sugar pill

Gabapentin

Active Comparator group

Description:

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.

Treatment:

Drug: Sugar pill

Drug: Clonidine