Trial Outcomes & Findings for Low Pain Prediction in Cesarean Section Patients (NCT NCT02143141)

Results Overview

Pain assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no pain to 100 indicating the most severe pain.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

13 participants

Primary outcome timeframe

24 hours

Results posted on

2018-09-10

Participant Flow

Recruitment and enrollment occurred between December 2011 and September 2013. The study was terminated due to extreme difficulty in recruiting patients willing to participate in the study.

Participant milestones

Participant milestones
Measure	Duramorph duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours duramorph: duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching.	no Duramorph no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively placebo: placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching.
Overall Study STARTED	7	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Duramorph duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours duramorph: duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching.	no Duramorph no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively placebo: placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching.
Overall Study pain scores at 24 hours not collected	1	0

Baseline Characteristics

Low Pain Prediction in Cesarean Section Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Duramorph n=7 Participants duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours duramorph: duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching.	no Duramorph n=6 Participants no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively placebo: placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching.	Total n=13 Participants Total of all reporting groups
Age, Continuous	32 years n=39 Participants	30 years n=41 Participants	31 years n=35 Participants
Sex/Gender, Customized female participants	7 Participants n=39 Participants	6 Participants n=41 Participants	13 Participants n=35 Participants
Region of Enrollment United States	7 Participants n=39 Participants	6 Participants n=41 Participants	13 Participants n=35 Participants
gravida	3 number n=39 Participants	2 number n=41 Participants	2 number n=35 Participants
para	1 number n=39 Participants	1 number n=41 Participants	1 number n=35 Participants
estimated gestational age of fetus	39 weeks n=39 Participants	39 weeks n=41 Participants	39 weeks n=35 Participants
height	64.8 inches n=39 Participants	64.5 inches n=41 Participants	64.6 inches n=35 Participants
weight	206 pounds n=39 Participants	166 pounds n=41 Participants	186 pounds n=35 Participants

PRIMARY outcome

Timeframe: 24 hours

Pain assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no pain to 100 indicating the most severe pain.

Outcome measures

Outcome measures
Measure	Duramorph n=7 Participants duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours duramorph: duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching.	no Duramorph n=6 Participants no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively placebo: placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching.
Pain	56 units on a scale Standard Deviation 27	21 units on a scale Standard Deviation 11

SECONDARY outcome

Timeframe: 24 hours

The itching assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no itching to 100 indicating the most severe itching.

Outcome measures

Outcome measures
Measure	Duramorph n=7 Participants duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours duramorph: duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching.	no Duramorph n=6 Participants no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively placebo: placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching.
Itching	55.3 units on a scale Standard Deviation 21.7	1.3 units on a scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: 24 hours

The nausea/vomiting assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no nausea/vomiting to 100 indicating the most severe nausea/vomiting.

Outcome measures

Outcome measures
Measure	Duramorph n=7 Participants duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours duramorph: duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching.	no Duramorph n=6 Participants no duramorph is administered spinally for surgery; subjects receive acetaminophen 1 G orally x 4 doses during first 24 hours postoperatively placebo: placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching.
Nausea/Vomiting	37 units on a scale Standard Deviation 38.2	6.2 units on a scale Standard Deviation 15.1

Adverse Events

Duramorph

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

no Duramorph

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. Jessica Booth

Wake Forest School of Medicine

Phone: 3367188278

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place