Trial Outcomes & Findings for Prospective Trial: Pain Management After Pectus Excavatum Repair, Epidural Versus PCA (NCT NCT01863498)

NCT ID: NCT01863498

Last Updated: 2020-11-03

Results Overview

The primary outcome variable is length of hospitalization after the intervention.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 65 participants
• Primary outcome timeframe: 3-8 days
• Results posted on: 2020-11-03

Participant Flow

Participant milestones

Measure	PCA Pain Control Patients will have PCA for pain control PCA: Patients will have PCA for pain control	Epidural Pain Control Patients will have an epidural for pain control Epidural: Patients will have an epidural for pain control
Overall Study STARTED	33	32
Overall Study COMPLETED	33	32
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	PCA Pain Control n=33 Participants Patients will have PCA for pain control PCA: Patients will have PCA for pain control	Epidural Pain Control n=32 Participants Patients will have an epidural for pain control Epidural: Patients will have an epidural for pain control	Total n=65 Participants Total of all reporting groups
Age, Continuous	14.5 years STANDARD_DEVIATION 1.3 • n=33 Participants	15 years STANDARD_DEVIATION 1.4 • n=32 Participants	14.75 years STANDARD_DEVIATION 1.36 • n=65 Participants
Sex: Female, Male Female	4 Participants n=33 Participants	1 Participants n=32 Participants	5 Participants n=65 Participants
Sex: Female, Male Male	29 Participants n=33 Participants	31 Participants n=32 Participants	60 Participants n=65 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Height	1.8 meters STANDARD_DEVIATION 0.5 • n=33 Participants	1.7 meters STANDARD_DEVIATION 0.1 • n=32 Participants	1.75 meters STANDARD_DEVIATION 0.36 • n=65 Participants
Weight	53.9 kg STANDARD_DEVIATION 7.7 • n=33 Participants	55.9 kg STANDARD_DEVIATION 10.4 • n=32 Participants	54.88 kg STANDARD_DEVIATION 9.11 • n=65 Participants
Corrective Index	34.9 index score STANDARD_DEVIATION 9.6 • n=33 Participants	28.6 index score STANDARD_DEVIATION 6.8 • n=32 Participants	31.80 index score STANDARD_DEVIATION 8.86 • n=65 Participants

PRIMARY outcome

Timeframe: 3-8 days

The primary outcome variable is length of hospitalization after the intervention.

Outcome measures

Measure	PCA Pain Control n=33 Participants Patients will have PCA for pain control PCA: Patients will have PCA for pain control	Epidural Pain Control n=32 Participants Patients will have an epidural for pain control Epidural: Patients will have an epidural for pain control
Length of Hospitalization After Surgery	111.4 hours Standard Deviation 51.4	111.3 hours Standard Deviation 18.5

SECONDARY outcome

Timeframe: Duration of operation, an average of 1 hour

Duration of operation in minutes

Outcome measures

Measure	PCA Pain Control n=33 Participants Patients will have PCA for pain control PCA: Patients will have PCA for pain control	Epidural Pain Control n=32 Participants Patients will have an epidural for pain control Epidural: Patients will have an epidural for pain control
Operation Time	58.9 minutes Standard Deviation 19.5	65.3 minutes Standard Deviation 22.9

SECONDARY outcome

Timeframe: Duration of time in operating room

Total operating room time in minutes

Outcome measures

Measure	PCA Pain Control n=33 Participants Patients will have PCA for pain control PCA: Patients will have PCA for pain control	Epidural Pain Control n=32 Participants Patients will have an epidural for pain control Epidural: Patients will have an epidural for pain control
Total Operating Room Time	102.8 minutes Standard Deviation 26.9	127.5 minutes Standard Deviation 28.4

Adverse Events

PCA Pain Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Epidural Pain 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. Shawn St. Peter

Children's Mercy Kansas City

Phone: 816-234-3575

Email: sspeter@cmh.edu

Results disclosure agreements

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