ACL Repair and Multimodal Analgesia

Study Overview
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Brief Summary
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This study will evaluate the effectiveness of an aggressive multimodal regimen versus standard multimodal for Anterior Cruciate Ligament (ACL) repair using hamstring graft for patients having surgery in our outpatient surgicenter.

Official Title
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ACL Repair and Multimodal Analgesia

Conditions
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Pain

Intervention / Treatment
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* Drug: multimodal:acetaminophen, gabapentin, ketamine, bupivacaine
* Drug: placebo pills and injectables


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of orthopedic surgeons on the study team scheduled for ACL repair using hamstring graft from the same leg will be considered for inclusion in this study. Other inclusion criteria are as follows: American Society of Anesthesiologists (ASA) physical status 1-3 BMI of < 40 kg/m2 Consents to general anesthesia and pre-operative femoral nerve block for case Exclusion Criteria: Any contraindication to a femoral nerve block Allergy to local anesthetics, nonsteroidal anti-inflammatory medications, ketamine, acetaminophen, hydromorphone, oxycodone Peripheral or central nervous system disease Renal or hepatic impairment History of opioid dependence or current regular narcotic use Significant psychiatric disease Pregnancy or lactation (by verbal report) Seizure Disorder History of post-operative nausea and vomiting Latex allergy Clinically significant cardiac or pulmonary disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: multimodal:acetaminophen, gabapentin, ketamine, bupivacaine<br>aggressive multimodal plus standard care, which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane | Drug: multimodal:acetaminophen, gabapentin, ketamine, bupivacaine<br>* acetaminophen, gabapentin, ketamine, bupivacaine and standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane<br>|
| Placebo Comparator: placebo pills and injectables<br>standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane | Drug: placebo pills and injectables<br>* receives standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane plus placebos of intervention arm meds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption in the Immediate Postoperative Period | This data will be entered into the participants electronic medical record and collected from their chart once the participant has been discharged. The immediate postoperative period covers the participant's entire time in the outpatient surgery center after they have entered the recovery room postoperatively. The amount of time they remain in the outpatient surgery center postoperatively varies from a minimum of 1 hour to a maximum of 10 hours and an average of 4 hours. | Up to 10 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores During Recovery | Pain scores during recovery period through the first 24 hours of recovery, recorded upon arrival to recovery room, 1-hr post-op, 24-hrs post-op. This outcome reports lowest and highest pain score since discharge to 24 hour phone call. Pain scores are collected verbally on a scale of 0-10 where 10 is the most severe pain. | up to 24 hours postoperatively | 
| Number of Participants Who Received Medication for Nausea | Number of participant who received medication for nausea prior to discharge and after discharge, up to 24 hours post-op. | Up to 24 hours following surgery | 
| Post-Operative Incidence of Nausea | Incidence of nausea as recorded in the electronic medical record (EMR) in the recovery room through the first 24-hrs post-op. | Up to 24 hours following surgery | 
| Post-Operative Nausea Scores | Nausea scores will be collected in post-operative recovery and 24 hours later (via phone). The participant will be asked to rate their nausea on a scale of 0 (no nausea) - 10 (worst possible). | Up to 24 hours following surgery | 
| Incidence of Post-Operative Pruritus | Pruritus in recovery and through the first 24 hours post-op. | Up to 24 hours following surgery | 
| Post-Operative Pruritis Score | Participants will be asked to rate their pruritis on a scale of 0 (no itching) - 10 (worst itchiness) while in post-op recovery room and then at 24 hours post-op via phone call. | Up to 24 hours following surgery | 
| Sedation Scale | Sedation scale measured in recovery room, 1-hr post op, and 24 hrs op. The Sedation Scale is scored from 0-10 where 0 = normal, no sleepier than average, 10 = sleepy, hard to stay awake. | Up to 24 hours following surgery | 
| Impact of Block Characteristics on Pain Control |  | Up to 24 hours following surgery | 
| Intraoperative Medication Use: Ketorolac and Lidocaine | All participants received standard induction medications. | From induction until arrival in post anesthesia care unit. | 
| Intraoperative Medication Use: Fentanyl | All participants received standard induction medications. | From induction until arrival in post anesthesia care unit. | 
| Number of Participants With Complications From the Procedure |  | Up to 24 hours following surgery | 
| Time to Discharge | Time to discharge from the recovery room (Phase I recovery) and the outpatient surgery center (Phase II recovery). | Up to 24 hours following surgery |