Nonopioid Analgesia After Arthroscopic Meniscus Surgery
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03820193 |
Recruitment Status :
Recruiting
First Posted : January 29, 2019
Last Update Posted : February 15, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Meniscus Disorder Narcotic Use | Drug: Celecoxib Drug: Hydrocodon/Acetaminophen Drug: Ketorolac Drug: Gabapentin Drug: Acetaminophen Drug: Diazepam | Early Phase 1 |
Study Design: This is a randomized, single blinded, standard of care-controlled clinical trial. All adult patients over eighteen desiring arthroscopic meniscus surgery will be eligible. Nonnarcotic postoperative pain control regimen described below were chosen based on previous studies in fracture care and joint arthroplasty.
Patients will be consented and recruited. Once participation has been determined and consent obtained, the names of participating patients will be provided to the research pharmacy. Patients will be randomized with a computer-generated table in 2 patient blocks by the research pharmacy. Patients postoperative analgesia will be divided into one of the following 2 treatment arms: 1) A novel nonopioid pain protocol or 2) traditional narcotic pain analgesia
Primary endpoints is reduction in pain as measured by Visual Analog Score and Patient Reported Outcome Measurement Informatics Systems. The endpoints will be collected at each post-operative day using a journal. Moreover, endpoints will be collected at the patient's first post-operative appointment. These appointments are scheduled within one-week of the index procedure.
Statistical Analysis: All continuous data will be analyzed using independent 2-group t tests and reported as means ± standard deviations. Categorical data will be compared between the 2 groups using chi-square tests and reported as counts and percentages. A preliminary test to confirm the quality of variances will be conducted prior to utilizing the t test to confirm the appropriate statistical analysis. Nonparametric equivalents Wilcoxon rank-sum and Fisher exact tests will be used as needed for nonnormal distributions and low variable numbers, respectively. A multivariable regression analysis was performed to assess for potential confounding demographic variables.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Care Provider) |
Primary Purpose: | Treatment |
Official Title: | Traditional vs. Nonopioid Analgesia After Arthroscopic Meniscus Surgery |
Actual Study Start Date : | January 22, 2019 |
Estimated Primary Completion Date : | January 20, 2020 |
Estimated Study Completion Date : | May 20, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Post-Operative Non Opioid Pain Protocol
Patients will be administered a post-operative non-opioid pain protocol consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam
|
Drug: Celecoxib
Post-Operative Non Opioid Pain Protocol
Other Name: Celebrex Drug: Ketorolac Post-Operative Non Opioid Pain Protocol
Other Name: Toradol Drug: Gabapentin Post-Operative Non Opioid Pain Protocol
Other Name: Neurontin Drug: Acetaminophen Post-Operative Non Opioid Pain Protocol
Other Name: Tylenol Drug: Diazepam Post-Operative Non Opioid Pain Protocol
Other Name: Valium |
Active Comparator: Post-Operative Traditional Pain Protocol
Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-acetaminophen
|
Drug: Hydrocodon/Acetaminophen
Traditionally used narcotic pain control
Other Name: Norco |
- Pain Levels [ Time Frame: 10 days post-operatively ]Patients record pain levels every 3 hours using Visual analog scales for 10 days post-operatively. Average daily pain was calculated for each patient. Higher values portend worse control.
- Patient Reported Outcome Measurement Information System [ Time Frame: 10 days post-operatively ]Patient Reported Outcome Measurement Information System - Pain Interference (PROMIS PI) scores collected nightly until study completion. Average PROMIS PI values calculated nightly. A higher score indicates more pain interference.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- All adult patients over age 18 scheduled for arthroscopic meniscus repair or partial menisectomy
Exclusion Criteria:
- Patients with a medical history of known allergies or intolerance to allergies or intolerance to Celebrex, Tylenol, Neurontin, dexamethasone, tramadol, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820193
Contact: Toufic R Jildeh, MD | 5172308511 | tjildeh1@hfhs.org |
United States, Michigan | |
Henry Ford Health System | Recruiting |
Detroit, Michigan, United States, 48202 | |
Contact: Toufic R Jildeh 517-230-8511 tjildeh1@hfhs.org |
Principal Investigator: | Toufic R Jildeh, MD | Henry Ford Health System |
Responsible Party: | Toufic R. Jildeh, Resident, Henry Ford Health System |
ClinicalTrials.gov Identifier: | NCT03820193 |
Other Study ID Numbers: |
123193 |
First Posted: | January 29, 2019 Key Record Dates |
Last Update Posted: | February 15, 2019 |
Last Verified: | February 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Per Request |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Acetaminophen Celecoxib Ketorolac Acetaminophen, hydrocodone drug combination Diazepam Gabapentin Hydrocodone Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents |
Antirheumatic Agents Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticonvulsants Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Antimanic Agents Analgesics, Opioid |