ACL-R Opioid Sparing Study

Opiate Sparing Pain Management Protocol After Anterior Cruciate Ligament Reconstruction Surgery

This is a randomized control trial to investigate the effectiveness of a multimodal opiate sparing analgesic regimen in controlling post-operative pain and potentially reduce post-operative opioid consumption in patients undergoing Anterior Cruciate Ligament Reconstruction (ACL-R).

Study Overview

• Status: Enrolling by invitation
• Conditions: Anterior Cruciate Ligament Injuries
• Intervention / Treatment: Drug: Opiate Sparing; Drug: Opiate Based

Detailed Description

There is increased attention on opioid prescription patterns and post-operative narcotic consumption in light of the ongoing opioid crisis in the United States. Patients with opioid use disorders often have their first exposure to opioids following a medical or surgical procedure (Shah et al., 2019). Approximately 6% of patients who were opioid native preoperatively and received opioids postoperatively became long term users. As orthopedic surgeons account for approximately 8% of all dispensed opioid prescriptions (Volkow et al., 2011), surgeons have investigated the effectiveness of multimodal analgesic regimens in controlling post-operative pain and reducing the amount of opioid consumption. Recent studies have shown that an opiate sparing regimen consisted of nonsteroidal anti-inflammatory drugs can control post-operative pain adequately while reducing opioid consumption in patients who underwent arthroscopic knee or shoulder surgeries (Gazendam et al., 2022; Jones et al., 2022). Currently, there is no clear consensus on pain management regimen after anterior cruciate ligament reconstruction.

The purpose of this study is to 1) investigate the difference in pain score and opioid consumption among patients who receive the opioid-based protocol and those who receive opioid-sparing protocol; 2) minimize and potentially eliminate the utilization of narcotics following anterior cruciate ligament reconstruction (ACL-R) surgery.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38138
      • Campbell Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 14-85 years of age.
• Patients undergoing primary ACL-R with or without meniscus repair or meniscectomy, with or without chondroplasty.
• Patients weigh at least 90lbs at time of enrollment.
• Surgery scheduled at a Campbell Clinic Surgery Center (Midtown or Wolf River).
• Willing and able to provide written informed consent.
• Willing and able to cooperate with postoperative therapy.
• Speak and read fluent English.

Exclusion Criteria:

• Multiligament knee reconstruction.
• Pre-injury opioid consumption.
• Substance abuse disorder (illicit drug abuse, alcoholism, etc).
• Concomitant injuries or surgeries warranting pain medication (i.e. polytrauma patient).
• Chronic pain syndrome.
• Renal disease.
• Currently taking selective serotonin reuptake inhibitors and/or serotonin and norepinephrine reuptake inhibitors.
• Known sensitivity, allergy, or intolerance to medications within protocols.
• History of diabetes.
• Currently taking glucagon-like peptide 1 agonist.
• Female patient who is pregnant on day of surgery or becomes pregnant during study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Opiate Sparing; Discharge medications: Medrol Dosepak, take per package instructions from postoperative day 1 to postoperative day 6.; Diclofenac 75 milligram (mg) twice per day from postoperative day 7 to postoperative day 14.; Tylenol 1000 mg three times per day from postoperative day 1 to postoperative day 14.; Gabapentin 100 mg three times per day from postoperative day 1 to postoperative day 14.; Methocarbamol (Robaxin) 750mg twice per day from postoperative day 1 to postoperative day 14.; Promethazine 25 mg every 8 hours as needed for nausea.; Aspirin 81 once per day from postoperative day 1 to postoperative day 30.; Senokot-S (Sennosides and Docusate) as needed for constipation.; 10 tablets of Tramadol 50mg as needed for moderate breakthrough pain only.; 5 tablets of oxycodone 5mg as needed for severe breakthrough pain only.; Supervised physical therapy to start within postoperative day 2 and postoperative day 7.	Drug: Opiate Sparing; Subjects will receive medications in the Opiate Sparing arm for pain control.
Active Comparator: Opiate Based; Discharge medications: Diclofenac 75 milligram (mg) twice per day from postoperative day 1 to postoperative day 14.; Tylenol 1000 mg three times per day from postoperative day 1 to postoperative day 14.; Gabapentin 100 mg three times per day from postoperative day 1 to postoperative day 14.; Methocarbamol (Robaxin) 750mg twice per day from postoperative day 1 to postoperative day 14.; Promethazine 25 mg every 8 hours as needed for nausea.; Aspirin 81 once per day from postoperative day 1 to postoperative day 30.; Senokot-S (Sennosides and Docusate) as needed for constipation.; 10 tablets of Tramadol 50mg as needed for moderate breakthrough pain only.; 5 tablets of oxycodone 5mg as needed for severe breakthrough pain only.; Supervised physical therapy to start within postoperative day 2 and postoperative day 7.	Drug: Opiate Based; Subjects will receive medications in the Opiate Based arm for pain control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	Record pain score with 0 being no pain at all and 10 being worst pain possible.	Once per day from postoperative day 1 to postoperative day 14; at two weeks follow up visit, 6 weeks follow up visit and 12 weeks follow up visit.
Oral morphine equivalent	Opiate pill count	daily pill count from postoperative day 1 to postoperative day 14; at 2-week follow up visit, 6-week follow up visit and 12-week follow up visit.

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of treatment-emergent adverse event.	From day of surgery to 12-week follow up visit.

Collaborators and Investigators

• Sponsor: Campbell Clinic
• Investigators: Principal Investigator: Joseph Lamplot, MD, Campbell Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: August 16, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Opiate Alkaloids
• Other Study ID Numbers: 24-09976-FB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No