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

Knee Arthroscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01112878
• Other study ID #: Pro00019373
• Status: Withdrawn
• Phase: Phase 4
• First received: April 23, 2010
• Last updated: September 10, 2015
• Start date: June 2015
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Knee Arthroscopy
• Shoulder Arthroscopy

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Patient satisfaction using a verbal rating scale from 0 to 100	0= Not satisfied 100= Excellent	1 month	No