Trial Outcomes & Findings for A Multimodal Analgesia Protocol Adapted for Ambulatory Surgery (NCT NCT04015908)

Last Updated: 2024-07-08

Results Overview

Pain as measured by a 0-10 Visual Analog Scale (VAS) pain scale, where "0" is the lowest score and "10" is the highest score. For example, 10 would be severe pain and 0 would be none. Cumulative scores were the total scores over 6 days and were expressed with the absolute totals with range. No subscales were used. Cumulative scores represent the absolute sum of each data point for 6 days. The total cumulative range for pain is 0-60.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

Cumulative every day after 6 days post-operative

Results posted on

2024-07-08

Participant Flow

Participant milestones

Participant milestones
Measure	Multi-modal 3 Different Non-opioid pain medication taken every 6 hours Celecoxib 100mg Acetaminophen 325mg Pregabalin 50 mg Plus, for breakthrough pain oxycodone 5-10 mg will be taken every 4 hours as needed for pain. Celecoxib: Celecoxib 100mg Acetaminophen: Acetaminophen 325mg Pregabalin: Pregabalin 50 mg Oxycodone: oxycodone 5-10 mg	Control 7 day supply of Percocet (oxycodone 5mg/acetaminophen 325 mg) to be taken 1-2 by mouth every 4 hours as needed for pain. Percocet: Percocet (oxycodone 5mg/acetaminophen 325 mg)
Overall Study STARTED	50	50
Overall Study COMPLETED	50	49
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Multi-modal 3 Different Non-opioid pain medication taken every 6 hours Celecoxib 100mg Acetaminophen 325mg Pregabalin 50 mg Plus, for breakthrough pain oxycodone 5-10 mg will be taken every 4 hours as needed for pain. Celecoxib: Celecoxib 100mg Acetaminophen: Acetaminophen 325mg Pregabalin: Pregabalin 50 mg Oxycodone: oxycodone 5-10 mg	Control 7 day supply of Percocet (oxycodone 5mg/acetaminophen 325 mg) to be taken 1-2 by mouth every 4 hours as needed for pain. Percocet: Percocet (oxycodone 5mg/acetaminophen 325 mg)
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Multi-modal n=50 Participants 3 Different Non-opioid pain medication taken every 6 hours Celecoxib 100mg Acetaminophen 325mg Pregabalin 50 mg Plus, for breakthrough pain oxycodone 5-10 mg will be taken every 4 hours as needed for pain. Celecoxib: Celecoxib 100mg Acetaminophen: Acetaminophen 325mg Pregabalin: Pregabalin 50 mg Oxycodone: oxycodone 5-10 mg	Control n=50 Participants 7 day supply of Percocet (oxycodone 5mg/acetaminophen 325 mg) to be taken 1-2 by mouth every 4 hours as needed for pain. Percocet: Percocet (oxycodone 5mg/acetaminophen 325 mg)	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=100 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=50 Participants	50 Participants n=50 Participants	100 Participants n=100 Participants
Age, Categorical >=65 years	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=100 Participants
Age, Continuous	32 years STANDARD_DEVIATION 11 • n=50 Participants	37 years STANDARD_DEVIATION 11 • n=50 Participants	35 years STANDARD_DEVIATION 11 • n=100 Participants
Sex: Female, Male Female	37 Participants n=50 Participants	32 Participants n=50 Participants	69 Participants n=100 Participants
Sex: Female, Male Male	13 Participants n=50 Participants	18 Participants n=50 Participants	31 Participants n=100 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Height	169 cm STANDARD_DEVIATION 9 • n=50 Participants	171 cm STANDARD_DEVIATION 8 • n=50 Participants	170 cm STANDARD_DEVIATION 9 • n=100 Participants
Weight	75 kg STANDARD_DEVIATION 13 • n=50 Participants	80 kg STANDARD_DEVIATION 13 • n=50 Participants	76 kg STANDARD_DEVIATION 13 • n=100 Participants
Body mass index	26 kg/m^2 STANDARD_DEVIATION 6 • n=50 Participants	27 kg/m^2 STANDARD_DEVIATION 4 • n=50 Participants	27 kg/m^2 STANDARD_DEVIATION 5 • n=100 Participants
Scopolamine patch	19 Participants n=50 Participants	19 Participants n=50 Participants	38 Participants n=100 Participants
Intraoperative fentanyl	110 mg STANDARD_DEVIATION 45 • n=50 Participants	110 mg STANDARD_DEVIATION 46 • n=50 Participants	110 mg STANDARD_DEVIATION 45 • n=100 Participants
PACU fentanyl	93 mg STANDARD_DEVIATION 66 • n=50 Participants	92 mg STANDARD_DEVIATION 77 • n=50 Participants	93 mg STANDARD_DEVIATION 72 • n=100 Participants

PRIMARY outcome

Timeframe: Cumulative every day after 6 days post-operative

Outcome measures

Outcome measures
Measure	Multi-modal n=50 Participants 3 Different Non-opioid pain medication taken every 6 hours Celecoxib 100mg Acetaminophen 325mg Pregabalin 50 mg Plus, for breakthrough pain oxycodone 5-10 mg will be taken every 4 hours as needed for pain. Celecoxib: Celecoxib 100mg Acetaminophen: Acetaminophen 325mg Pregabalin: Pregabalin 50 mg Oxycodone: oxycodone 5-10 mg	Control n=49 Participants 7 day supply of Percocet (oxycodone 5mg/acetaminophen 325 mg) to be taken 1-2 by mouth every 4 hours as needed for pain. Percocet: Percocet (oxycodone 5mg/acetaminophen 325 mg)
Amount of Pain Experienced	28 Score on a scale Interval 14.0 to 35.0	35 Score on a scale Interval 28.0 to 41.0

SECONDARY outcome

Timeframe: Cumulative every day after 6 days post-operative

Nausea as measured by a 0-10 Visual Analog Scale (VAS) nausea scale, where "0" is the lowest score and "10" is the highest score. For example, 10 would be severe nausea and 0 would be none. Cumulative scores were the total scores over 6 days and were expressed with the absolute totals with range. No subscales were used. Cumulative scores represent the absolute sum of each data point for 6 days. The total cumulative range for nausea is 0-60.

Outcome measures

Outcome measures
Measure	Multi-modal n=50 Participants 3 Different Non-opioid pain medication taken every 6 hours Celecoxib 100mg Acetaminophen 325mg Pregabalin 50 mg Plus, for breakthrough pain oxycodone 5-10 mg will be taken every 4 hours as needed for pain. Celecoxib: Celecoxib 100mg Acetaminophen: Acetaminophen 325mg Pregabalin: Pregabalin 50 mg Oxycodone: oxycodone 5-10 mg	Control n=49 Participants 7 day supply of Percocet (oxycodone 5mg/acetaminophen 325 mg) to be taken 1-2 by mouth every 4 hours as needed for pain. Percocet: Percocet (oxycodone 5mg/acetaminophen 325 mg)
Amount of Nausea Experienced	0 Score on a scale Interval 0.0 to 0.0	0 Score on a scale Interval 0.0 to 8.0

SECONDARY outcome

Timeframe: Cumulative every day after 6 days post-operative

Itching as measured by a 0-10 Visual Analog Scale (VAS) itching scale, where "0" is the lowest score and "10" is the highest score. For example, 10 would be severe itching and 0 would be none. Cumulative scores were the total scores over 6 days and were expressed with the absolute totals with range. No subscales were used. Cumulative scores represent the absolute sum of each data point for 6 days. The total cumulative range for itching is 0-60.

Outcome measures

Outcome measures
Measure	Multi-modal n=50 Participants 3 Different Non-opioid pain medication taken every 6 hours Celecoxib 100mg Acetaminophen 325mg Pregabalin 50 mg Plus, for breakthrough pain oxycodone 5-10 mg will be taken every 4 hours as needed for pain. Celecoxib: Celecoxib 100mg Acetaminophen: Acetaminophen 325mg Pregabalin: Pregabalin 50 mg Oxycodone: oxycodone 5-10 mg	Control n=49 Participants 7 day supply of Percocet (oxycodone 5mg/acetaminophen 325 mg) to be taken 1-2 by mouth every 4 hours as needed for pain. Percocet: Percocet (oxycodone 5mg/acetaminophen 325 mg)
Amount of Itching Experienced	0 Score on a scale Interval 0.0 to 0.0	0 Score on a scale Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: Cumulative every day after 6 days post-operative

Oxycodone use, measured by number of 5-mg tablets as standard dose

Outcome measures

Outcome measures
Measure	Multi-modal n=50 Participants 3 Different Non-opioid pain medication taken every 6 hours Celecoxib 100mg Acetaminophen 325mg Pregabalin 50 mg Plus, for breakthrough pain oxycodone 5-10 mg will be taken every 4 hours as needed for pain. Celecoxib: Celecoxib 100mg Acetaminophen: Acetaminophen 325mg Pregabalin: Pregabalin 50 mg Oxycodone: oxycodone 5-10 mg	Control n=49 Participants 7 day supply of Percocet (oxycodone 5mg/acetaminophen 325 mg) to be taken 1-2 by mouth every 4 hours as needed for pain. Percocet: Percocet (oxycodone 5mg/acetaminophen 325 mg)
Amount of Oxycodone Used	0 tablets Interval 0.0 to 2.0	8 tablets Interval 1.25 to 16.0

Adverse Events

Multi-modal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jeffrey D. Swenson

University of Utah

Phone: 801-581-6393

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place