Pain
Conditions
Brief summary
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.
Interventions
DRUGmultimodal:acetaminophen, gabapentin, ketamine, bupivacaine
acetaminophen, gabapentin, ketamine, bupivacaine and standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane
DRUGplacebo pills and injectables
receives standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane plus placebos of intervention arm meds
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption in the Immediate Postoperative Period | Up to 10 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Received Medication for Nausea | Up to 24 hours following surgery | Number of participant who received medication for nausea prior to discharge and after discharge, up to 24 hours post-op. |
| Post-Operative Incidence of Nausea | Up to 24 hours following surgery | Incidence of nausea as recorded in the electronic medical record (EMR) in the recovery room through the first 24-hrs post-op. |
| Post-Operative Nausea Scores | Up to 24 hours following surgery | 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). |
| Incidence of Post-Operative Pruritus | Up to 24 hours following surgery | Pruritus in recovery and through the first 24 hours post-op. |
| Post-Operative Pruritis Score | Up to 24 hours following surgery | 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. |
| Pain Scores During Recovery | up to 24 hours postoperatively | 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. |
| Impact of Block Characteristics on Pain Control | Up to 24 hours following surgery | — |
| Intraoperative Medication Use: Ketorolac and Lidocaine | From induction until arrival in post anesthesia care unit. | All participants received standard induction medications. |
| Intraoperative Medication Use: Fentanyl | From induction until arrival in post anesthesia care unit. | All participants received standard induction medications. |
| Number of Participants With Complications From the Procedure | Up to 24 hours following surgery | — |
| Time to Discharge | Up to 24 hours following surgery | Time to discharge from the recovery room (Phase I recovery) and the outpatient surgery center (Phase II recovery). |
| Sedation Scale | Up to 24 hours following surgery | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine aggressive multimodal plus standard care, which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane
multimodal:acetaminophen, gabapentin, ketamine, bupivacaine: acetaminophen, gabapentin, ketamine, bupivacaine and standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane | 55 |
| Placebo Pills and Injectables standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane
placebo pills and injectables: receives standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane plus placebos of intervention arm meds | 57 |
| Total | 112 |
Baseline characteristics
| Characteristic | Placebo Pills and Injectables | Total | Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine |
|---|---|---|---|
| Age, Continuous | 32.2 years STANDARD_DEVIATION 8.8 | 31.3 years STANDARD_DEVIATION 8.6 | 30.5 years STANDARD_DEVIATION 8.5 |
| ASA Physical Status ASA 1 | 39 Participants | 79 Participants | 40 Participants |
| ASA Physical Status ASA 2 | 18 Participants | 33 Participants | 15 Participants |
| Body Mass Index | 26.5 kg/m^2 STANDARD_DEVIATION 4.3 | 26.4 kg/m^2 STANDARD_DEVIATION 4.2 | 26.3 kg/m^2 STANDARD_DEVIATION 4.4 |
| Height | 175.8 cm STANDARD_DEVIATION 8.6 | 175.9 cm STANDARD_DEVIATION 8.7 | 175.9 cm STANDARD_DEVIATION 8.6 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 57 participants | 112 participants | 55 participants |
| Sex: Female, Male Female | 21 Participants | 37 Participants | 16 Participants |
| Sex: Female, Male Male | 36 Participants | 75 Participants | 39 Participants |
| Smoking Current Smoker | 9 Participants | 12 Participants | 3 Participants |
| Smoking Former Smoker | 5 Participants | 10 Participants | 5 Participants |
| Smoking Never a Smoker | 41 Participants | 90 Participants | 49 Participants |
| Weight | 82.2 kg STANDARD_DEVIATION 16.9 | 81.7 kg STANDARD_DEVIATION 16.3 | 81.1 kg STANDARD_DEVIATION 15.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 57 |
| other Total, other adverse events | 0 / 55 | 3 / 57 |
| serious Total, serious adverse events | 0 / 55 | 0 / 57 |
Outcome results
Primary
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.
Time frame: Up to 10 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine | Opioid Consumption in the Immediate Postoperative Period | 12.0 morphine mg equivalents | Standard Deviation 11.9 |
| Placebo Pills and Injectables | Opioid Consumption in the Immediate Postoperative Period | 14.4 morphine mg equivalents | Standard Deviation 9.3 |
Secondary
Impact of Block Characteristics on Pain Control
Time frame: Up to 24 hours following surgery
Population: This data was not collected. All participants had a femoral nerve block. The quality of this block was not assessed.
Secondary
Incidence of Post-Operative Pruritus
Pruritus in recovery and through the first 24 hours post-op.
Time frame: Up to 24 hours following surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine | Incidence of Post-Operative Pruritus | Number of patients with pruritis OR to discharge | 8 Participants |
| Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine | Incidence of Post-Operative Pruritus | Number of patients with pruritis discharge to 24 h | 13 Participants |
| Placebo Pills and Injectables | Incidence of Post-Operative Pruritus | Number of patients with pruritis OR to discharge | 10 Participants |
| Placebo Pills and Injectables | Incidence of Post-Operative Pruritus | Number of patients with pruritis discharge to 24 h | 19 Participants |
Secondary
Intraoperative Medication Use: Fentanyl
All participants received standard induction medications.
Time frame: From induction until arrival in post anesthesia care unit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine | Intraoperative Medication Use: Fentanyl | 125 mcg | Standard Deviation 64.4 |
| Placebo Pills and Injectables | Intraoperative Medication Use: Fentanyl | 128 mcg | Standard Deviation 81.8 |
Secondary
Intraoperative Medication Use: Ketorolac and Lidocaine
All participants received standard induction medications.
Time frame: From induction until arrival in post anesthesia care unit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine | Intraoperative Medication Use: Ketorolac and Lidocaine | Intraoperative Ketorolac | 15.0 mg | Standard Deviation 4.1 |
| Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine | Intraoperative Medication Use: Ketorolac and Lidocaine | Intraoperative Lidocaine | 71.5 mg | Standard Deviation 28.4 |
| Placebo Pills and Injectables | Intraoperative Medication Use: Ketorolac and Lidocaine | Intraoperative Ketorolac | 14.7 mg | Standard Deviation 4.5 |
| Placebo Pills and Injectables | Intraoperative Medication Use: Ketorolac and Lidocaine | Intraoperative Lidocaine | 65.6 mg | Standard Deviation 36.9 |
Secondary
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.
Time frame: Up to 24 hours following surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine | Number of Participants Who Received Medication for Nausea | Anti-Nausea Medication Before Discharge | 8 Participants |
| Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine | Number of Participants Who Received Medication for Nausea | Anti-Nausea Medication after Discharge | 6 Participants |
| Placebo Pills and Injectables | Number of Participants Who Received Medication for Nausea | Anti-Nausea Medication Before Discharge | 7 Participants |
| Placebo Pills and Injectables | Number of Participants Who Received Medication for Nausea | Anti-Nausea Medication after Discharge | 3 Participants |
Secondary
Number of Participants With Complications From the Procedure
Time frame: Up to 24 hours following surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine | Number of Participants With Complications From the Procedure | 0 Participants |
| Placebo Pills and Injectables | Number of Participants With Complications From the Procedure | 0 Participants |
Secondary
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.
Time frame: up to 24 hours postoperatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine | Pain Scores During Recovery | Lowest Score Upon Arrival to Recovery Room | 2.3 score on a scale | Standard Deviation 2.1 |
| Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine | Pain Scores During Recovery | Highest Score Upon Arrival to Recovery Room | 4.8 score on a scale | Standard Deviation 2.4 |
| Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine | Pain Scores During Recovery | 1 hour post-op | 3.4 score on a scale | Standard Deviation 1.9 |
| Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine | Pain Scores During Recovery | 24 hours post-op | 2.4 score on a scale | Standard Deviation 1.8 |
| Placebo Pills and Injectables | Pain Scores During Recovery | 24 hours post-op | 2.6 score on a scale | Standard Deviation 1.7 |
| Placebo Pills and Injectables | Pain Scores During Recovery | Lowest Score Upon Arrival to Recovery Room | 3.0 score on a scale | Standard Deviation 1.6 |
| Placebo Pills and Injectables | Pain Scores During Recovery | 1 hour post-op | 3.8 score on a scale | Standard Deviation 1.6 |
| Placebo Pills and Injectables | Pain Scores During Recovery | Highest Score Upon Arrival to Recovery Room | 5.5 score on a scale | Standard Deviation 2 |
Secondary
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.
Time frame: Up to 24 hours following surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine | Post-Operative Incidence of Nausea | Nausea Post op to discharge | 16 Participants |
| Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine | Post-Operative Incidence of Nausea | Nausea - discharge to 24 hour | 24 Participants |
| Placebo Pills and Injectables | Post-Operative Incidence of Nausea | Nausea Post op to discharge | 12 Participants |
| Placebo Pills and Injectables | Post-Operative Incidence of Nausea | Nausea - discharge to 24 hour | 23 Participants |
Secondary
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).
Time frame: Up to 24 hours following surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine | Post-Operative Nausea Scores | Post Operative (recovery room) | 1.2 score on a scale | Standard Deviation 2.3 |
| Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine | Post-Operative Nausea Scores | 24 hours post-op | 2.2 score on a scale | Standard Deviation 3 |
| Placebo Pills and Injectables | Post-Operative Nausea Scores | Post Operative (recovery room) | 0.7 score on a scale | Standard Deviation 1.7 |
| Placebo Pills and Injectables | Post-Operative Nausea Scores | 24 hours post-op | 1.6 score on a scale | Standard Deviation 2.7 |
Secondary
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.
Time frame: Up to 24 hours following surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine | Post-Operative Pruritis Score | Post Operative (recovery room) | 0.4 score on a scale | Standard Deviation 1 |
| Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine | Post-Operative Pruritis Score | 24 hours post-op | 0.7 score on a scale | Standard Deviation 1.4 |
| Placebo Pills and Injectables | Post-Operative Pruritis Score | Post Operative (recovery room) | 0.7 score on a scale | Standard Deviation 1.7 |
| Placebo Pills and Injectables | Post-Operative Pruritis Score | 24 hours post-op | 1.2 score on a scale | Standard Deviation 2.1 |
Secondary
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.
Time frame: Up to 24 hours following surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine | Sedation Scale | 1 hour post-op in Recovery Room | 5.0 score on a scale | Standard Deviation 2.3 |
| Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine | Sedation Scale | 24 hours post-op | 4.2 score on a scale | Standard Deviation 3 |
| Placebo Pills and Injectables | Sedation Scale | 1 hour post-op in Recovery Room | 4.6 score on a scale | Standard Deviation 2.2 |
| Placebo Pills and Injectables | Sedation Scale | 24 hours post-op | 4.3 score on a scale | Standard Deviation 2.8 |
Secondary
Time to Discharge
Time to discharge from the recovery room (Phase I recovery) and the outpatient surgery center (Phase II recovery).
Time frame: Up to 24 hours following surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine | Time to Discharge | Discharge from Recovery Room | 64.8 minutes | Standard Deviation 17.7 |
| Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine | Time to Discharge | Discharge from Outpatient Center | 132.1 minutes | Standard Deviation 64.2 |
| Placebo Pills and Injectables | Time to Discharge | Discharge from Recovery Room | 61.4 minutes | Standard Deviation 19.5 |
| Placebo Pills and Injectables | Time to Discharge | Discharge from Outpatient Center | 123.6 minutes | Standard Deviation 48.6 |