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

NCT01112878 | Withdrawn Phase 4 DMC

• 1 other identifier: Pro00019373
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Arthroscopy; Knee Arthroscopy

Keywords

Shoulder arthroscopy; Knee arthroscopy; Clonidine; Gabapentin; Pain management; Ambulatory surgery; Perioperative outcome; Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Opioid consumption obtained from the recorded data

  1 month

• postoperative nausea and vomiting using a Verbal Rating Scale

  1 month

• 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

Study Arms (3)

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.

Drug: Gabapentin; Drug: Clonidine

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.

Drug: Sugar pill; Drug: Gabapentin

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.

Drug: Sugar pill; Drug: Clonidine

Interventions

Sugar pill DRUG

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.

Also known as: placebo

Clonidine; Gabapentin

Gabapentin DRUG

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.

Also known as: Neurontin

Clonidine; Sugar Pill

Clonidine DRUG

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.

Also known as: Catapres

Gabapentin; Sugar Pill

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Sugars; Gabapentin; Clonidine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbohydrates; Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ronald H Wender, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Anesthesiology

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: April 29, 2010
• Study Start: June 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 14, 2015

Record last verified: 2015-09

Locations

US (1)