High Pain Intervention in Cesarean Sections

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT01298778
• Collaborator: (none)
• Enrollment: 69
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 6.3

Study Details

Study Description

Brief Summary

In previous studies the investigators have seen that the severity of pain one day after cesarean delivery can predict the presence of pain and depression 2 months later. The investigators believe those at risk for severe acute post-partum pain can be identified, and medical interventions can be tailored to manage postoperative pain more effectively.

Condition or Disease	Intervention/Treatment	Phase
Other Chronic Postoperative Pain	Drug: Duramorph 150; Drug: Acetaminophen; Drug: Duramorph 300	N/A

Detailed Description

This study is randomizing patients into 2 different groups and seeing if by altering our pain management with this group of patients their acute 24 hour evoked pain is less than anticipated; and the incidence of persistent pain and depression when contacted 2 months after delivery is decreased. This study is designed to see if these additional interventions would prove effective for patients at risk of having high pain level after cesarean surgery.

Study Design

• Study Type: Interventional
• Actual Enrollment: 69 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Improving Pain Relief For Those Who Need It Most After Cesarean Delivery
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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.	Drug: Duramorph 150; Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses
Active Comparator: 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.	Drug: Acetaminophen; Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses; Drug: Duramorph 300; Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses

Outcome Measures

Primary Outcome Measures

1. Severity of Acute Pain [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.

Secondary Outcome Measures

1. Incidence of Persistent Pain [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.

2. Pain [24 hour]

   resting pain, worst pain

3. Analgesic Consumption [24 hour]

   total amount of analgesic consumption

4. Incidence of Depression [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.

5. Average Pain Over 24 Hours [24 hours]

Other Outcome Measures

1. Pruritus [24 hours]

   side effects-percentage of subjects requiring treatment

2. Emetic Symptoms [24hours]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• elective cesarean section

• age >/= 18 years old

• not allergic proposed study medications

• predicted to experience high pain postop based on preoperative evaluation

Exclusion Criteria:

• allergy to study medications

• known hepatic disease

• weight > 300 lbs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Forsyth Medical Center-Sara Lee Center for Women's Health	Winston-Salem	North Carolina	United States	27103

Sponsors and Collaborators

• Wake Forest University Health Sciences

Investigators

• Principal Investigator: Peter H. Pan, MD, MSEE, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT01298778
• Other Study ID Numbers: IRB00012376
• First Posted: Feb 18, 2011
• Last Update Posted: Sep 10, 2018
• Last Verified: Aug 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wake Forest University Health Sciences: chronic pain post delivery; postpartum depression; tailored pain management
• Additional relevant MeSH terms: Pain, Postoperative; Acetaminophen; Morphine

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Standard of Care	Acetaminophen and Increased Dose of Duramorph
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	33	36
COMPLETED	30	30
NOT COMPLETED	3	6

Baseline Characteristics

Arm/Group Title	Standard of Care	Acetaminophen and Increased Dose of Duramorph	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	30	30	60
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	30 100%	30 100%	60 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	30 100%	30 100%	60 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	30 100%	30 100%	60 100%
Height-cm (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	163 (6)	164 (6)	163.3 (6)
Weight-kg (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	88 (17)	92 (19)	89.7 (17.7)
Gestational Age-weeks (weeks gestation) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks gestation]	39 (0.3)	39 (0.7)	39 (0.5)
Parity (number previous deliveries) [Mean (Full Range) ]
Mean (Full Range) [number previous deliveries]	1	1	1
Previous Cesarean Section (Count of Participants)
Count of Participants [Participants]	27 90%	24 80%	51 85%
ASA class (units on a scale) [Median (Full Range) ]
Median (Full Range) [units on a scale]	2	2	2

Outcome Measures

1. Primary Outcome

Title	Severity of Acute Pain
Description	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.
Time Frame	24 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care	Acetaminophen and Increased Dose of Duramorph
Arm/Group Description	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	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
Measure Participants	30	30
Mean (Standard Deviation) [mm]	46 (25)	31 (17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Acetaminophen and Increased Dose of Duramorph
	Comments	acute pain scores with movement at 24 hours
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Incidence of Persistent Pain
Description	to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces persistent pain up to 2 months post delivery.
Time Frame	2 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care	Acetaminophen and Increased Dose of Duramorph
Arm/Group Description	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	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
Measure Participants	30	30
Number [percentage of participants]	13 43.3%	10 33.3%

3. Secondary Outcome

Title	Pain
Description	resting pain, worst pain
Time Frame	24 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care	Acetaminophen and Increased Dose of Duramorph
Arm/Group Description	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	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
Measure Participants	30	30
resting pain score over 24 hrs	19	4
worst pain score over 24 hrs	69	62

4. Secondary Outcome

Title	Analgesic Consumption
Description	total amount of analgesic consumption
Time Frame	24 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care	Acetaminophen and Increased Dose of Duramorph
Arm/Group Description	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	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
Measure Participants	30	30
IV PCA morphine	15	15
total 24 hr opioid use	21	15

5. Secondary Outcome

Title	Incidence of Depression
Description	to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces postpartum depression up to 2 months post delivery.
Time Frame	2 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care	Acetaminophen and Increased Dose of Duramorph
Arm/Group Description	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 150: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses	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 Duramorph 300: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses
Measure Participants	30	30
Count of Participants [Participants]	3 10%	4 13.3%

6. Secondary Outcome

Title	Average Pain Over 24 Hours
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Standard of Care	Acetaminophen and Increased Dose of Duramorph
Arm/Group Description	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	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
Measure Participants	30	30
Mean (Standard Deviation) [units on a scale]	37 (19)	23 (14)

7. Other Pre-specified Outcome

Title	Pruritus
Description	side effects-percentage of subjects requiring treatment
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

percentage of patients with pruritis requiring treatment.

Arm/Group Title	Standard of Care	Acetaminophen and Increased Dose of Duramorph
Arm/Group Description	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	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
Measure Participants	30	30
Count of Participants [Participants]	15 50%	21 70%

8. Other Pre-specified Outcome

Title	Emetic Symptoms
Description	side effect potential with the increased dose of duramorph-percentage experiencing such symptoms
Time Frame	24hours

Outcome Measure Data

Analysis Population Description

percentage of patients reporting emetic symptoms requiring treatment

Arm/Group Title	Standard of Care	Acetaminophen and Increased Dose of Duramorph
Arm/Group Description	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	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
Measure Participants	30	30
Count of Participants [Participants]	16 53.3%	18 60%

Adverse Events

Time Frame	Participants were followed at 24 hours postoperatively and for 8 weeks postpartum.
Adverse Event Reporting Description	Outcome measures for incidence of pruritis and emetic symptoms have been reported in the arms section as those were expected outcomes that could be measurable. These are all anticipated events for such surgery patients and do not exceed the normal frequency threshold; therefore they were not considered adverse events.
Arm/Group Title	Standard of Care		Acetaminophen and Increased Dose of Duramorph
Arm/Group Description	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		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
All Cause Mortality
	Standard of Care		Acetaminophen and Increased Dose of Duramorph
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard of Care		Acetaminophen and Increased Dose of Duramorph
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Standard of Care		Acetaminophen and Increased Dose of Duramorph
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.