Trial Outcomes & Findings for Recommendations of Enhanced Recovery Interventions for Patient's Clinical Team and Collection of Associated Data (NCT NCT04606264)

Last Updated: 2026-05-28

Results Overview

The primary endpoint for this domain is the REMAP Periop primary outcome of hospital free days at 30 days after the elective surgical encounter.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

3395 participants

Primary outcome timeframe

Day 0 - Day 30

Results posted on

2026-05-28

Participant Flow

Participant milestones

Participant milestones
Measure	PONV Supraoptimal Prophylaxis & Neuraxial and Regional Analgesia Block 2 Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron IT morphine and QL1	PONV Optimal Prophylaxis & Neuraxial Analgesia Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Intrathecal Morphine	PONV Optimal Prophylaxis & Regional Analgesia Block 1 Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Paravertebral block	PONV Optimal Prophylaxis & Regional Analgesia Block 2 Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron QL1	PONV Optimal Prophylaxis & Neuraxial and Regional Analgesia Block 1 Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron IT morphine and Paravertebral	PONV Optimal Prophylaxis & Neuraxial and Regional Analgesia Block 2 Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron IT morphine and QL1	PONV Supraoptimal Prophylaxis & Neuraxial Analgesia Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron Intrathecal morphine	PONV Supraoptimal Prophylaxis & Regional Analgesia Block 1 Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron Paravertebral block	PONV Supraoptimal Prophylaxis & Regional Analgesia Block 2 Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron QL1	PONV Supraoptimal Prophylaxis & Neuraxial and Regional Analgesia Block 1 Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron IT morphine and Paravertebral
Overall Study STARTED	434	128	135	132	134	135	179	161	149	1808
Overall Study COMPLETED	393	113	116	112	121	118	157	130	136	1581
Overall Study NOT COMPLETED	41	15	19	20	13	17	22	31	13	227

Reasons for withdrawal

Reasons for withdrawal
Measure	PONV Supraoptimal Prophylaxis & Neuraxial and Regional Analgesia Block 2 Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron IT morphine and QL1	PONV Optimal Prophylaxis & Neuraxial Analgesia Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Intrathecal Morphine	PONV Optimal Prophylaxis & Regional Analgesia Block 1 Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Paravertebral block	PONV Optimal Prophylaxis & Regional Analgesia Block 2 Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron QL1	PONV Optimal Prophylaxis & Neuraxial and Regional Analgesia Block 1 Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron IT morphine and Paravertebral	PONV Optimal Prophylaxis & Neuraxial and Regional Analgesia Block 2 Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron IT morphine and QL1	PONV Supraoptimal Prophylaxis & Neuraxial Analgesia Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron Intrathecal morphine	PONV Supraoptimal Prophylaxis & Regional Analgesia Block 1 Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron Paravertebral block	PONV Supraoptimal Prophylaxis & Regional Analgesia Block 2 Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron QL1	PONV Supraoptimal Prophylaxis & Neuraxial and Regional Analgesia Block 1 Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron IT morphine and Paravertebral
Overall Study Protocol Violation	34	14	17	15	13	15	22	29	12	210
Overall Study Enrolled in Another Trial	7	1	2	5	0	2	0	2	1	16
Overall Study Surgery Canceled	0	0	0	0	0	0	0	0	0	1

Baseline Characteristics

Recommendations of Enhanced Recovery Interventions for Patient's Clinical Team and Collection of Associated Data

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PONV Optimal Prophylaxis & Neuraxial and Regional Analgesia Block 1 n=134 Participants Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron IT morphine and Paravertebral	PONV Optimal Prophylaxis & Neuraxial and Regional Analgesia Block 2 n=135 Participants Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron IT morphine and QL1	PONV Supraoptimal Prophylaxis & Neuraxial Analgesia n=179 Participants Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron Intrathecal morphine	PONV Supraoptimal Prophylaxis & Regional Analgesia Block 1 n=161 Participants Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron Paravertebral block	PONV Supraoptimal Prophylaxis & Regional Analgesia Block 2 n=149 Participants Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron QL1	PONV Supraoptimal Prophylaxis & Neuraxial and Regional Analgesia Block 1 n=1808 Participants Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron IT morphine and Paravertebral	PONV Supraoptimal Prophylaxis & Neuraxial and Regional Analgesia Block 2 n=434 Participants Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron IT morphine and QL1	Total n=3395 Participants Total of all reporting groups	PONV Optimal Prophylaxis & Regional Analgesia Block 2 n=132 Participants Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron QL1	PONV Optimal Prophylaxis & Regional Analgesia Block 1 n=135 Participants Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Paravertebral block	PONV Optimal Prophylaxis & Neuraxial Analgesia n=128 Participants Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Intrathecal Morphine
Sex: Female, Male Male	39 Participants n=24 Participants	38 Participants n=107 Participants	60 Participants n=1000 Participants	40 Participants	48 Participants n=204 Participants	566 Participants	134 Participants n=792 Participants	1030 Participants n=20 Participants	29 Participants n=65 Participants	40 Participants n=14 Participants	36 Participants n=51 Participants
Age, Categorical <=18 years	0 Participants n=24 Participants	1 Participants n=107 Participants	0 Participants n=1000 Participants	1 Participants	0 Participants n=204 Participants	4 Participants	0 Participants n=792 Participants	6 Participants n=20 Participants	0 Participants n=65 Participants	0 Participants n=14 Participants	0 Participants n=51 Participants
Age, Categorical Between 18 and 65 years	92 Participants n=24 Participants	95 Participants n=107 Participants	101 Participants n=1000 Participants	112 Participants	103 Participants n=204 Participants	1199 Participants	280 Participants n=792 Participants	2253 Participants n=20 Participants	91 Participants n=65 Participants	88 Participants n=14 Participants	92 Participants n=51 Participants
Age, Categorical >=65 years	42 Participants n=24 Participants	39 Participants n=107 Participants	78 Participants n=1000 Participants	48 Participants	46 Participants n=204 Participants	605 Participants	154 Participants n=792 Participants	1136 Participants n=20 Participants	41 Participants n=65 Participants	47 Participants n=14 Participants	36 Participants n=51 Participants
Sex: Female, Male Female	95 Participants n=24 Participants	97 Participants n=107 Participants	119 Participants n=1000 Participants	121 Participants	101 Participants n=204 Participants	1242 Participants	300 Participants n=792 Participants	2365 Participants n=20 Participants	103 Participants n=65 Participants	95 Participants n=14 Participants	92 Participants n=51 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=24 Participants	0 Participants n=107 Participants	0 Participants n=1000 Participants	0 Participants	0 Participants n=204 Participants	2 Participants	0 Participants n=792 Participants	4 Participants n=20 Participants	0 Participants n=65 Participants	0 Participants n=14 Participants	1 Participants n=51 Participants
Race (NIH/OMB) Asian	0 Participants n=24 Participants	2 Participants n=107 Participants	3 Participants n=1000 Participants	0 Participants	0 Participants n=204 Participants	19 Participants	6 Participants n=792 Participants	33 Participants n=20 Participants	2 Participants n=65 Participants	1 Participants n=14 Participants	0 Participants n=51 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=24 Participants	0 Participants n=107 Participants	0 Participants n=1000 Participants	0 Participants	0 Participants n=204 Participants	2 Participants	0 Participants n=792 Participants	2 Participants n=20 Participants	0 Participants n=65 Participants	0 Participants n=14 Participants	0 Participants n=51 Participants
Race (NIH/OMB) Black or African American	12 Participants n=24 Participants	13 Participants n=107 Participants	21 Participants n=1000 Participants	19 Participants	16 Participants n=204 Participants	211 Participants	50 Participants n=792 Participants	375 Participants n=20 Participants	15 Participants n=65 Participants	7 Participants n=14 Participants	11 Participants n=51 Participants
Race (NIH/OMB) White	117 Participants n=24 Participants	115 Participants n=107 Participants	152 Participants n=1000 Participants	137 Participants	132 Participants n=204 Participants	1500 Participants	362 Participants n=792 Participants	2864 Participants n=20 Participants	112 Participants n=65 Participants	124 Participants n=14 Participants	113 Participants n=51 Participants
Race (NIH/OMB) More than one race	0 Participants n=24 Participants	0 Participants n=107 Participants	0 Participants n=1000 Participants	0 Participants	0 Participants n=204 Participants	0 Participants	0 Participants n=792 Participants	0 Participants n=20 Participants	0 Participants n=65 Participants	0 Participants n=14 Participants	0 Participants n=51 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=24 Participants	5 Participants n=107 Participants	3 Participants n=1000 Participants	5 Participants	1 Participants n=204 Participants	74 Participants	16 Participants n=792 Participants	117 Participants n=20 Participants	3 Participants n=65 Participants	3 Participants n=14 Participants	3 Participants n=51 Participants

PRIMARY outcome

Timeframe: Day 0 - Day 30

Population: Each participant was assigned an arm/intervention for the PONV domain and Analgesia domain. To make sure 1 participant was not counted twice, we had to arrange the participant flow by each of the possible combinations instead of separately. It was pre-specified to report the data for Outcome Measure 1 per individual intervention and not by combination.

The primary endpoint for this domain is the REMAP Periop primary outcome of hospital free days at 30 days after the elective surgical encounter.

Outcome measures

Outcome measures
Measure	PONV Supraoptimal Prophylaxis n=682 Participants Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron	Neuraxial Analgesia n=580 Participants Intrathecal morphine	Regional Analgesia Block 2 n=270 Participants QL1	Neuraxial and Regional Analgesia Block 1 n=246 Participants IT morphine and Paravertebral	Neuraxial and Regional Analgesia Block 2 n=248 Participants IT morphine and QL1	Neuraxial and Regional Analgesia Block 1 n=1702 Participants IT morphine and Paravertebral	Neuraxial and Regional Analgesia Block 2 n=511 Participants IT morphine and QL1
30 Day Hospital Free Days	27 Number of hospital free days Interval 25.0 to 28.0	27 Number of hospital free days Interval 25.0 to 28.0	26 Number of hospital free days Interval 24.0 to 28.0	27 Number of hospital free days Interval 25.0 to 28.0	27 Number of hospital free days Interval 25.0 to 28.0	27 Number of hospital free days Interval 25.0 to 28.0	27 Number of hospital free days Interval 25.0 to 28.0

SECONDARY outcome

Timeframe: 0 - 24 hours post-surgery

Population: Each participant was assigned an arm/intervention for the PONV domain and Analgesia domain. To make sure 1 participant was not counted twice, we had to arrange the participant flow by each of the possible combinations instead of separately. The different domains were analyzed separately though. They were not analyzed as a combination. This analysis only included the PONV domain because the measure is specific to PONV and does not involve analgesia.

Did the participant receive postoperative antiemetic medication within 24 hours of completion of surgery (number of participants who did receive postoperative antiemetics)

Outcome measures

Outcome measures
Measure	PONV Supraoptimal Prophylaxis n=680 Participants Pre-op * aprepitant * dimenhydrinate * perphenazine * ondansetron Induction -dexamethasone Emergence -ondansetron	Neuraxial Analgesia n=579 Participants Intrathecal morphine	Regional Analgesia Block 2 QL1	Neuraxial and Regional Analgesia Block 1 IT morphine and Paravertebral	Neuraxial and Regional Analgesia Block 2 IT morphine and QL1	Neuraxial and Regional Analgesia Block 1 IT morphine and Paravertebral	Neuraxial and Regional Analgesia Block 2 IT morphine and QL1
Change in Postoperative Nausea and Vomiting (PONV) by Measurement Incidences of Emesis Within 24 Hours Post Surgery	246 Participants	271 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 0-24 hours post-surgery

Population: Each participant was assigned an arm/intervention for the PONV domain and Analgesia domain. To make sure 1 participant was not counted twice, we had to arrange the participant flow by each of the possible combinations instead of separately. The different domains were analyzed separately though. They were not analyzed as a combination. This analysis only included the analgesia domain because the measure is specific to analgesia and does not involve PONV.

OME measurement is a method to compare and standardize different opioids administered to participants to account for varying strengths. OME is measured as a rate in milligrams per day and modeled as a continuous endpoint. For analysis purposes, OME was converted to log(OME) + 1