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

Phase 4

Withdrawn

• Conditions: Shoulder Arthroscopy; Knee Arthroscopy
• Interventions: Drug: Gabapentin; Drug: Sugar pill; Drug: Clonidine

• Registration Number: NCT01112878
• Lead Sponsor: Cedars-Sinai Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-23
• Study First Submitted QC: 2010-04-28
• Study First Posted: 2010-04-29
• Study Start: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-10
• Last Update Posted: 2015-09-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Sugar Pill	Gabapentin	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.
Clonidine	Sugar pill	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.
Gabapentin	Sugar pill	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.
Sugar Pill	Clonidine	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.
Clonidine	Gabapentin	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.
Gabapentin	Clonidine	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.

Primary Outcome Measures

Name	Time	Method
Postoperative Pain using a Verbal Rating Scale (VRS)	1 month	Outcomes will be measured with follow up questionnaires at 1, 2, or 3, then 7 and 30 days after surgery

Secondary Outcome Measures

Name	Time	Method
return to normal activities of daily living using follow up questionnaires	1 month	return to normal activities of daily living(including dietary intake, bowel and bladder function, physical activities)
Patient satisfaction using a verbal rating scale from 0 to 100	1 month	0= Not satisfied 100= Excellent
Opioid consumption obtained from the recorded data	1 month	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)
postoperative nausea and vomiting using a Verbal Rating Scale	1 month	Outcomes will be measured with follow up questionnaires at 1, 2, or 3, then 7 and 30 days after surgery

Trial Locations

Locations (1)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States