Trial Outcomes & Findings for Single vs Double Epidural Catheter Analgesia for Scoliosis Surgery (NCT NCT01900626)

NCT ID: NCT01900626

Last Updated: 2019-05-08

Results Overview

The pain scores will be examined using the Numeric Rating Scale (NRS). NRS score ranges from 0-10. Higher score represents more pain/worse outcome

Recruitment status

TERMINATED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

72 hours

Results posted on

2019-05-08

Participant Flow

2 participants were enrolled in the study. However,this study was being closed due to difficulty with enrollment and changes to standard of care. No data was analysed for outcome measures.

Participant milestones

Participant milestones
Measure	Single Epidural Catheter	Double Epidural Catheter
Overall Study STARTED	1	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Epidural Catheter	Double Epidural Catheter
Overall Study study was closed due to low enrollment	1	1

Baseline Characteristics

Single vs Double Epidural Catheter Analgesia for Scoliosis Surgery

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 72 hours

Population: This study is being closed due to difficulty with enrollment and changes to standard of care. No participant data was collected for outcome measures

The pain scores will be examined using the Numeric Rating Scale (NRS). NRS score ranges from 0-10. Higher score represents more pain/worse outcome

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 hours

Population: This study is being closed due to difficulty with enrollment and changes to standard of care. No participant data was collected for outcome measures

The pain scores will be examined using the Numeric Rating Scale (NRS). NRS score ranges from 0-10. Higher score represents more pain/worse outcome

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 hours

Population: This study is being closed due to difficulty with enrollment and changes to standard of care.No data analyses was done

Hydromorphone usage measured in mcg/kg/day. No min/max. More hydromorphone usage represents worse outcome

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: This study is being closed due to difficulty with enrollment and changes to standard of care.No data analyses was done

Functional outcome will be measured by the Pediatric Outcomes Data Collection Instrument (PODCI). Scores range from 0-100, lower score represents higher degree of disability

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: This study is being closed due to difficulty with enrollment and changes to standard of care.No data analyses was done

Functional outcome will be measured by the Scoliosis Research Society-22r (SRS-22r). Scores range from 0-110, higher scores represent less disability/better outcome

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: This study is being closed due to difficulty with enrollment and changes to standard of care.No data analyses was done

Functional outcome will be measured by the Owestry Disability Index (ODI). ODI represents following disability levels: 0% -20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.

Outcome measures

Outcome data not reported

Adverse Events

Single Epidural Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Double Epidural Catheter

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

Benjamin J. Walker, MD

University of Wisconsin School of Medicine and Public Health

Phone: 608/262-8858

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Single Epidural Catheter n=1 Participants	Double Epidural Catheter n=1 Participants	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants