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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Knee Arthroscopy; Shoulder Arthroscopy
• Intervention / Treatment: Drug: Gabapentin; Drug: Clonidine; Drug: Sugar pill

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Sugar Pill; 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; 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.; Other Names: Neurontin; Drug: Clonidine; 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.; Other Names: Catapres
ACTIVE_COMPARATOR: Clonidine; 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: Gabapentin; 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.; Other Names: Neurontin; Drug: Sugar 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.; Other Names: placebo
ACTIVE_COMPARATOR: Gabapentin; 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: Clonidine; 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.; Other Names: Catapres; Drug: Sugar 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.; Other Names: placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (ANTICIPATED): June 1, 2015
• Study Completion (ANTICIPATED): June 1, 2015

Study Registration Dates

• First Submitted: April 23, 2010
• First Submitted That Met QC Criteria: April 28, 2010
• First Posted (ESTIMATE): April 29, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): September 14, 2015
• Last Update Submitted That Met QC Criteria: September 10, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Analgesia; Pain management; Gabapentin; Ambulatory surgery; Clonidine; Knee arthroscopy; Shoulder arthroscopy; Perioperative outcome
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Sympatholytics; Gabapentin; Clonidine
• Other Study ID Numbers: Pro00019373