Skip to main content
Clinical Trials/NCT01112878
NCT01112878WithdrawnPhase 4

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

Cedars-Sinai Medical Center1 site in 1 countryStarted: June 2015Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Withdrawn
Locations
1
Primary Endpoint
Postoperative Pain using a Verbal Rating Scale (VRS)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Prevention
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

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.

Intervention: Gabapentin (Drug)

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.

Intervention: Clonidine (Drug)

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.

Intervention: Sugar pill (Drug)

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.

Intervention: Gabapentin (Drug)

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.

Intervention: Sugar pill (Drug)

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.

Intervention: Clonidine (Drug)

Outcomes

Primary Outcomes

Postoperative Pain using a Verbal Rating Scale (VRS)

Time Frame: 1 month

Outcomes will be measured with follow up questionnaires at 1, 2, or 3, then 7 and 30 days after surgery

Secondary Outcomes

  • 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)
  • Opioid consumption obtained from the recorded data(1 month)
  • postoperative nausea and vomiting using a Verbal Rating Scale(1 month)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ronald Wender

Chairman, Department of Anesthesiology

Cedars-Sinai Medical Center

Study Sites (1)

Loading locations...

Similar Trials