Trial Outcomes & Findings for ACL Repair and Multimodal Analgesia (NCT NCT01868425)

NCT ID: NCT01868425

Last Updated: 2020-03-30

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 112 participants
• Primary outcome timeframe: Up to 10 hours
• Results posted on: 2020-03-30

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	55	57
Overall Study COMPLETED	55	57
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine n=55 Participants 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	Placebo Pills and Injectables n=57 Participants 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	Total n=112 Participants Total of all reporting groups
Age, Continuous	30.5 years STANDARD_DEVIATION 8.5 • n=55 Participants	32.2 years STANDARD_DEVIATION 8.8 • n=57 Participants	31.3 years STANDARD_DEVIATION 8.6 • n=112 Participants
Sex: Female, Male Female	16 Participants n=55 Participants	21 Participants n=57 Participants	37 Participants n=112 Participants
Sex: Female, Male Male	39 Participants n=55 Participants	36 Participants n=57 Participants	75 Participants n=112 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	55 participants n=55 Participants	57 participants n=57 Participants	112 participants n=112 Participants
Smoking Current Smoker	3 Participants n=55 Participants	9 Participants n=57 Participants	12 Participants n=112 Participants
Smoking Former Smoker	5 Participants n=55 Participants	5 Participants n=57 Participants	10 Participants n=112 Participants
Smoking Never a Smoker	49 Participants n=55 Participants	41 Participants n=57 Participants	90 Participants n=112 Participants
Weight	81.1 kg STANDARD_DEVIATION 15.8 • n=55 Participants	82.2 kg STANDARD_DEVIATION 16.9 • n=57 Participants	81.7 kg STANDARD_DEVIATION 16.3 • n=112 Participants
Height	175.9 cm STANDARD_DEVIATION 8.6 • n=55 Participants	175.8 cm STANDARD_DEVIATION 8.6 • n=57 Participants	175.9 cm STANDARD_DEVIATION 8.7 • n=112 Participants
Body Mass Index	26.3 kg/m^2 STANDARD_DEVIATION 4.4 • n=55 Participants	26.5 kg/m^2 STANDARD_DEVIATION 4.3 • n=57 Participants	26.4 kg/m^2 STANDARD_DEVIATION 4.2 • n=112 Participants
ASA Physical Status ASA 1	40 Participants n=55 Participants	39 Participants n=57 Participants	79 Participants n=112 Participants
ASA Physical Status ASA 2	15 Participants n=55 Participants	18 Participants n=57 Participants	33 Participants n=112 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine n=55 Participants 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	Placebo Pills and Injectables n=57 Participants 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
Opioid Consumption in the Immediate Postoperative Period	12.0 morphine mg equivalents Standard Deviation 11.9	14.4 morphine mg equivalents Standard Deviation 9.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine n=55 Participants 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	Placebo Pills and Injectables n=57 Participants 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
Pain Scores During Recovery Highest Score Upon Arrival to Recovery Room	4.8 score on a scale Standard Deviation 2.4	5.5 score on a scale Standard Deviation 2.0
Pain Scores During Recovery 1 hour post-op	3.4 score on a scale Standard Deviation 1.9	3.8 score on a scale Standard Deviation 1.6
Pain Scores During Recovery Lowest Score Upon Arrival to Recovery Room	2.3 score on a scale Standard Deviation 2.1	3.0 score on a scale Standard Deviation 1.6
Pain Scores During Recovery 24 hours post-op	2.4 score on a scale Standard Deviation 1.8	2.6 score on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine n=55 Participants 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	Placebo Pills and Injectables n=57 Participants 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
Number of Participants Who Received Medication for Nausea Anti-Nausea Medication Before Discharge	8 Participants	7 Participants
Number of Participants Who Received Medication for Nausea Anti-Nausea Medication after Discharge	6 Participants	3 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine n=55 Participants 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	Placebo Pills and Injectables n=57 Participants 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
Post-Operative Incidence of Nausea Nausea Post op to discharge	16 Participants	12 Participants
Post-Operative Incidence of Nausea Nausea - discharge to 24 hour	24 Participants	23 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine n=55 Participants 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	Placebo Pills and Injectables n=57 Participants 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
Post-Operative Nausea Scores 24 hours post-op	2.2 score on a scale Standard Deviation 3.0	1.6 score on a scale Standard Deviation 2.7
Post-Operative Nausea Scores Post Operative (recovery room)	1.2 score on a scale Standard Deviation 2.3	0.7 score on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: Up to 24 hours following surgery

Pruritus in recovery and through the first 24 hours post-op.

Outcome measures

Measure	Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine n=55 Participants 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	Placebo Pills and Injectables n=57 Participants 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
Incidence of Post-Operative Pruritus Number of patients with pruritis OR to discharge	8 Participants	10 Participants
Incidence of Post-Operative Pruritus Number of patients with pruritis discharge to 24 h	13 Participants	19 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine n=55 Participants 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	Placebo Pills and Injectables n=57 Participants 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
Post-Operative Pruritis Score Post Operative (recovery room)	0.4 score on a scale Standard Deviation 1.0	0.7 score on a scale Standard Deviation 1.7
Post-Operative Pruritis Score 24 hours post-op	0.7 score on a scale Standard Deviation 1.4	1.2 score on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine n=55 Participants 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	Placebo Pills and Injectables n=57 Participants 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
Sedation Scale 1 hour post-op in Recovery Room	5.0 score on a scale Standard Deviation 2.3	4.6 score on a scale Standard Deviation 2.2
Sedation Scale 24 hours post-op	4.2 score on a scale Standard Deviation 3.0	4.3 score on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From induction until arrival in post anesthesia care unit.

All participants received standard induction medications.

Outcome measures

Measure	Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine n=55 Participants 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	Placebo Pills and Injectables n=57 Participants 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
Intraoperative Medication Use: Ketorolac and Lidocaine Intraoperative Ketorolac	15.0 mg Standard Deviation 4.1	14.7 mg Standard Deviation 4.5
Intraoperative Medication Use: Ketorolac and Lidocaine Intraoperative Lidocaine	71.5 mg Standard Deviation 28.4	65.6 mg Standard Deviation 36.9

SECONDARY outcome

Timeframe: From induction until arrival in post anesthesia care unit.

All participants received standard induction medications.

Outcome measures

Measure	Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine n=55 Participants 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	Placebo Pills and Injectables n=57 Participants 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
Intraoperative Medication Use: Fentanyl	125 mcg Standard Deviation 64.4	128 mcg Standard Deviation 81.8

SECONDARY outcome

Timeframe: Up to 24 hours following surgery

Outcome measures

Measure	Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine n=55 Participants 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	Placebo Pills and Injectables n=57 Participants 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
Number of Participants With Complications From the Procedure	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 24 hours following surgery

Time to discharge from the recovery room (Phase I recovery) and the outpatient surgery center (Phase II recovery).

Outcome measures

Measure	Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine n=55 Participants 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	Placebo Pills and Injectables n=57 Participants 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
Time to Discharge Discharge from Recovery Room	64.8 minutes Standard Deviation 17.7	61.4 minutes Standard Deviation 19.5
Time to Discharge Discharge from Outpatient Center	132.1 minutes Standard Deviation 64.2	123.6 minutes Standard Deviation 48.6

Adverse Events

Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Pills and Injectables

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine n=55 participants at risk 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	Placebo Pills and Injectables n=57 participants at risk 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
Surgical and medical procedures Light Headed After Surgery	0.00% 0/55 • up to 24 hours post-op	1.8% 1/57 • up to 24 hours post-op
Nervous system disorders Vivid Dreams	0.00% 0/55 • up to 24 hours post-op	1.8% 1/57 • up to 24 hours post-op
Gastrointestinal disorders Nausea	0.00% 0/55 • up to 24 hours post-op	1.8% 1/57 • up to 24 hours post-op

Additional Information

John Shepler

University of Wisconsin - Madison

Phone: 608-263-8100

Email: jashepler@wisc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place