Trial Outcomes & Findings for High Pain Intervention in Cesarean Sections (NCT NCT01298778)

NCT ID: NCT01298778

Last Updated: 2018-09-10

Results Overview

to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces acute post-delivery pain (24 hour evoked pain post delivery). The scale utilized was a 100mm sliding VAS, where 0mm=no pain up to 100mm-worst pain imaginable.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 69 participants
• Primary outcome timeframe: 24 hour
• Results posted on: 2018-09-10

Participant Flow

Participants were approached during the pre-anesthesia evaluation regarding their interest in the study. Once consent was signed, subjects completed their pre-surgery questionnaires. On the day of surgery, I/E criteria were re-reviewed for confirmed enrollment for study.A total of 74 were consented with 69 randomized, with 60 completing the study.

Participant milestones

Measure	Standard of Care Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses	Acetaminophen and Increased Dose of Duramorph Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses
Overall Study STARTED	33	36
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Measure	Standard of Care Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses	Acetaminophen and Increased Dose of Duramorph Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses
Overall Study Lost to Follow-up	2	3
Overall Study Incorrect use of VAS	1	0
Overall Study Withdrawal by Subject	0	1
Overall Study Protocol Violation	0	1
Overall Study not meet inclusion/exclusion criteria	0	1

Baseline Characteristics

High Pain Intervention in Cesarean Sections

Baseline characteristics by cohort

Measure	Standard of Care n=30 Participants Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses	Acetaminophen and Increased Dose of Duramorph n=30 Participants Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 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	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants
Height-cm	163 cm STANDARD_DEVIATION 6 • n=5 Participants	164 cm STANDARD_DEVIATION 6 • n=7 Participants	163.3 cm STANDARD_DEVIATION 6 • n=5 Participants
Weight-kg	88 kg STANDARD_DEVIATION 17 • n=5 Participants	92 kg STANDARD_DEVIATION 19 • n=7 Participants	89.7 kg STANDARD_DEVIATION 17.7 • n=5 Participants
Gestational Age-weeks	39 weeks gestation STANDARD_DEVIATION 0.3 • n=5 Participants	39 weeks gestation STANDARD_DEVIATION 0.7 • n=7 Participants	39 weeks gestation STANDARD_DEVIATION 0.5 • n=5 Participants
Parity	1 number previous deliveries n=5 Participants	1 number previous deliveries n=7 Participants	1 number previous deliveries n=5 Participants
Previous Cesarean Section	27 Participants n=5 Participants	24 Participants n=7 Participants	51 Participants n=5 Participants
ASA class	2 units on a scale n=5 Participants	2 units on a scale n=7 Participants	2 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 24 hour

to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces acute post-delivery pain (24 hour evoked pain post delivery). The scale utilized was a 100mm sliding VAS, where 0mm=no pain up to 100mm-worst pain imaginable.

Outcome measures

Measure	Standard of Care n=30 Participants Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses	Acetaminophen and Increased Dose of Duramorph n=30 Participants Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses
Severity of Acute Pain	46 mm Standard Deviation 25	31 mm Standard Deviation 17

SECONDARY outcome

Timeframe: 2 months

to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces persistent pain up to 2 months post delivery.

Outcome measures

Measure	Standard of Care n=30 Participants Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses	Acetaminophen and Increased Dose of Duramorph n=30 Participants Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses
Incidence of Persistent Pain	13 percentage of participants	10 percentage of participants

SECONDARY outcome

Timeframe: 24 hour

resting pain, worst pain

Outcome measures

Measure	Standard of Care n=30 Participants Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses	Acetaminophen and Increased Dose of Duramorph n=30 Participants Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses
Pain resting pain score over 24 hrs	19 units on a scale, 0 -none, 100-worst Interval 0.0 to 33.0	4 units on a scale, 0 -none, 100-worst Interval 0.0 to 10.0
Pain worst pain score over 24 hrs	69 units on a scale, 0 -none, 100-worst Interval 49.0 to 77.0	62 units on a scale, 0 -none, 100-worst Interval 42.0 to 70.0

SECONDARY outcome

Timeframe: 24 hour

total amount of analgesic consumption

Outcome measures

Measure	Standard of Care n=30 Participants Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses	Acetaminophen and Increased Dose of Duramorph n=30 Participants Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses
Analgesic Consumption IV PCA morphine	15 mg Interval 11.0 to 32.0	15 mg Interval 11.0 to 29.0
Analgesic Consumption total 24 hr opioid use	21 mg Interval 11.0 to 37.0	15 mg Interval 13.0 to 33.0

SECONDARY outcome

Timeframe: 2 months

to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces postpartum depression up to 2 months post delivery.

Outcome measures

Measure	Standard of Care n=30 Participants Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses	Acetaminophen and Increased Dose of Duramorph n=30 Participants Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses
Incidence of Depression	3 Participants	4 Participants

SECONDARY outcome

Timeframe: 24 hours

Population: VAS pain score of 0=no pain at all up to 100 being worst pain imaginable.

Outcome measures

Measure	Standard of Care n=30 Participants Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses	Acetaminophen and Increased Dose of Duramorph n=30 Participants Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses
Average Pain Over 24 Hours	37 units on a scale Standard Deviation 19	23 units on a scale Standard Deviation 14

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours

Population: percentage of patients with pruritis requiring treatment.

side effects-percentage of subjects requiring treatment

Outcome measures

Measure	Standard of Care n=30 Participants Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses	Acetaminophen and Increased Dose of Duramorph n=30 Participants Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses
Pruritus	15 Participants	21 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24hours

Population: percentage of patients reporting emetic symptoms requiring treatment

side effect potential with the increased dose of duramorph-percentage experiencing such symptoms

Outcome measures

Measure	Standard of Care n=30 Participants Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses	Acetaminophen and Increased Dose of Duramorph n=30 Participants Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care. Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses
Emetic Symptoms	16 Participants	18 Participants

Adverse Events

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acetaminophen and Increased Dose of 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: 336-718-8278

Email: jbooth@wakehealth.edu

Results disclosure agreements

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