Trial Outcomes & Findings for Multimodal Pain Management for Cesarean Delivery (NCT NCT02922985)

NCT ID: NCT02922985

Last Updated: 2021-12-06

Results Overview

Every opioid intake by the patient in the first 48 hours after CD will be recorded and quantified in morphine milligram equivalents

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 120 participants
• Primary outcome timeframe: 48 hours post cesarean delivery
• Results posted on: 2021-12-06

Participant Flow

Participant milestones

Measure	Placebo Control Group Patients will receive a placebo dose of all three study medications Normal saline: Normal saline will be given intravenously, intra-muscularly, and subcutaneously in the same volume as the study drugs for the patients in the placebo group.	Multimodal Pain Regimen Group Patients will receive the actual study medication for all three study medications. Intravenous acetominophen: One dose if 1 gram intravenous to be given pre-surgery Ketorolac, intramuscular: One dose of 60 mg Intramuscular to be given at time of skin closure Bupivacaine, subcutaneous: Inject 20 mL of 0.25% bupivacaine at the site of anticipated skin incision.
Overall Study STARTED	60	60
Overall Study COMPLETED	60	60
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multimodal Pain Management for Cesarean Delivery

Baseline characteristics by cohort

Measure	Placebo Control Group n=60 Participants Patients will receive a placebo dose of all three study medications Normal saline: Normal saline will be given intravenously, intra-muscularly, and subcutaneously in the same volume as the study drugs for the patients in the placebo group.	Multimodal Pain Regimen Group n=60 Participants Patients will receive the actual study medication for all three study medications. Intravenous acetominophen: One dose if 1 gram intravenous to be given pre-surgery Ketorolac, intramuscular: One dose of 60 mg Intramuscular to be given at time of skin closure Bupivacaine, subcutaneous: Inject 20 mL of 0.25% bupivacaine at the site of anticipated skin incision.	Total n=120 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	60 Participants n=5 Participants	60 Participants n=7 Participants	120 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	29.4 years STANDARD_DEVIATION 5.2 • n=5 Participants	29.6 years STANDARD_DEVIATION 5.1 • n=7 Participants	29.5 years STANDARD_DEVIATION 5.1 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	60 Participants n=7 Participants	120 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Hispanic	39 Participants n=5 Participants	40 Participants n=7 Participants	79 Participants n=5 Participants
Race/Ethnicity, Customized Race · Caucasian	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Race · African American	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants	60 participants n=7 Participants	120 participants n=5 Participants
worst pain in the last 24 hours prior to cesarean delivery	2 score on a scale n=5 Participants	3 score on a scale n=7 Participants	2 score on a scale n=5 Participants

PRIMARY outcome

Timeframe: 48 hours post cesarean delivery

Every opioid intake by the patient in the first 48 hours after CD will be recorded and quantified in morphine milligram equivalents

Outcome measures

Measure	Placebo Control Group n=60 Participants Patients will receive a placebo dose of all three study medications Normal saline: Normal saline will be given intravenously, intra-muscularly, and subcutaneously in the same volume as the study drugs for the patients in the placebo group.	Multimodal Pain Regimen Group n=60 Participants Patients will receive the actual study medication for all three study medications. Intravenous acetominophen: One dose if 1 gram intravenous to be given pre-surgery Ketorolac, intramuscular: One dose of 60 mg Intramuscular to be given at time of skin closure Bupivacaine, subcutaneous: Inject 20 mL of 0.25% bupivacaine at the site of anticipated skin incision.
Total Opioid Intake in Morphine Milligram Equivalents in the First 48 Hours After Cesarean Delivery (CD)	42 morphine milligram equivalents Interval 30.0 to 60.0	49.5 morphine milligram equivalents Interval 32.0 to 69.0

SECONDARY outcome

Timeframe: 48 hours post cesarean delivery

Time, in hours, to first administration of opioid pain medication post operatively

Outcome measures

Measure	Placebo Control Group n=60 Participants Patients will receive a placebo dose of all three study medications Normal saline: Normal saline will be given intravenously, intra-muscularly, and subcutaneously in the same volume as the study drugs for the patients in the placebo group.	Multimodal Pain Regimen Group n=60 Participants Patients will receive the actual study medication for all three study medications. Intravenous acetominophen: One dose if 1 gram intravenous to be given pre-surgery Ketorolac, intramuscular: One dose of 60 mg Intramuscular to be given at time of skin closure Bupivacaine, subcutaneous: Inject 20 mL of 0.25% bupivacaine at the site of anticipated skin incision.
Time to First Administration of Opioid Pain Medication Post Operatively	6.05 hours Interval 1.9 to 13.5	6.35 hours Interval 2.2 to 16.3

SECONDARY outcome

Timeframe: 6-12 hours post-operatively

Pain score at 6-12 hours post-operatively, expressed on a pain scale from 0-10 with the higher score meaning worse pain (outcome).

Outcome measures

Measure	Placebo Control Group n=60 Participants Patients will receive a placebo dose of all three study medications Normal saline: Normal saline will be given intravenously, intra-muscularly, and subcutaneously in the same volume as the study drugs for the patients in the placebo group.	Multimodal Pain Regimen Group n=60 Participants Patients will receive the actual study medication for all three study medications. Intravenous acetominophen: One dose if 1 gram intravenous to be given pre-surgery Ketorolac, intramuscular: One dose of 60 mg Intramuscular to be given at time of skin closure Bupivacaine, subcutaneous: Inject 20 mL of 0.25% bupivacaine at the site of anticipated skin incision.
Pain Score at 6-12 Hours Post Operatively	6 score on a scale Interval 2.0 to 7.0	6 score on a scale Interval 0.25 to 7.0

SECONDARY outcome

Timeframe: 7 days post delivery

Population: We could not get the outcome on two patients from placebo control group and three patients from multimodal pain regimen group due to patients not responding to calls. These 5 five subjects were considered lost to follow up for this outcome.

Number of opioid pain tablets remaining on post-operative day #7 from hospital discharge as reported by patients

Outcome measures

Measure	Placebo Control Group n=58 Participants Patients will receive a placebo dose of all three study medications Normal saline: Normal saline will be given intravenously, intra-muscularly, and subcutaneously in the same volume as the study drugs for the patients in the placebo group.	Multimodal Pain Regimen Group n=57 Participants Patients will receive the actual study medication for all three study medications. Intravenous acetominophen: One dose if 1 gram intravenous to be given pre-surgery Ketorolac, intramuscular: One dose of 60 mg Intramuscular to be given at time of skin closure Bupivacaine, subcutaneous: Inject 20 mL of 0.25% bupivacaine at the site of anticipated skin incision.
Number of Opioid Pain Tablets Remaining on Post-operative Day #7 From the Discharge Prescription.	18 Tablets Interval 12.0 to 24.0	19 Tablets Interval 8.5 to 25.0

SECONDARY outcome

Timeframe: From time of hospital admission to time of discharge home up to 168 hours.

Time to discharge from hospital, measured in hours

Outcome measures

Measure	Placebo Control Group n=60 Participants Patients will receive a placebo dose of all three study medications Normal saline: Normal saline will be given intravenously, intra-muscularly, and subcutaneously in the same volume as the study drugs for the patients in the placebo group.	Multimodal Pain Regimen Group n=60 Participants Patients will receive the actual study medication for all three study medications. Intravenous acetominophen: One dose if 1 gram intravenous to be given pre-surgery Ketorolac, intramuscular: One dose of 60 mg Intramuscular to be given at time of skin closure Bupivacaine, subcutaneous: Inject 20 mL of 0.25% bupivacaine at the site of anticipated skin incision.
Hospital Length of Stay	50.2 hours Interval 41.5 to 52.5	50 hours Interval 42.9 to 52.0

SECONDARY outcome

Timeframe: 24 hours post-operatively

Pain Score at 24 Hours Post Operatively, expressed on a pain scale from 0-10 with the higher score meaning worse pain (outcome).

Outcome measures

Measure	Placebo Control Group n=60 Participants Patients will receive a placebo dose of all three study medications Normal saline: Normal saline will be given intravenously, intra-muscularly, and subcutaneously in the same volume as the study drugs for the patients in the placebo group.	Multimodal Pain Regimen Group n=60 Participants Patients will receive the actual study medication for all three study medications. Intravenous acetominophen: One dose if 1 gram intravenous to be given pre-surgery Ketorolac, intramuscular: One dose of 60 mg Intramuscular to be given at time of skin closure Bupivacaine, subcutaneous: Inject 20 mL of 0.25% bupivacaine at the site of anticipated skin incision.
Pain Score at 24 Hours Post-operatively	5 score on a scale Interval 2.0 to 7.0	6 score on a scale Interval 3.0 to 7.0

SECONDARY outcome

Timeframe: 48 hours post-operatively

Pain Score at 48 Hours Post-operatively, expressed on a pain scale from 0-10 with the higher score meaning worse pain (outcome).

Outcome measures

Measure	Placebo Control Group n=60 Participants Patients will receive a placebo dose of all three study medications Normal saline: Normal saline will be given intravenously, intra-muscularly, and subcutaneously in the same volume as the study drugs for the patients in the placebo group.	Multimodal Pain Regimen Group n=60 Participants Patients will receive the actual study medication for all three study medications. Intravenous acetominophen: One dose if 1 gram intravenous to be given pre-surgery Ketorolac, intramuscular: One dose of 60 mg Intramuscular to be given at time of skin closure Bupivacaine, subcutaneous: Inject 20 mL of 0.25% bupivacaine at the site of anticipated skin incision.
Pain Score at 48 Hours Post-operatively	4 score on a scale Interval 0.0 to 6.0	3 score on a scale Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: 5 minutes after birth

This is the Apgar score of the newborn collected at 5 minutes. Range is from 0-10, with the higher scores meaning a better outcome.

Outcome measures

Measure	Placebo Control Group n=60 Participants Patients will receive a placebo dose of all three study medications Normal saline: Normal saline will be given intravenously, intra-muscularly, and subcutaneously in the same volume as the study drugs for the patients in the placebo group.	Multimodal Pain Regimen Group n=60 Participants Patients will receive the actual study medication for all three study medications. Intravenous acetominophen: One dose if 1 gram intravenous to be given pre-surgery Ketorolac, intramuscular: One dose of 60 mg Intramuscular to be given at time of skin closure Bupivacaine, subcutaneous: Inject 20 mL of 0.25% bupivacaine at the site of anticipated skin incision.
Apgar Score at 5 Minutes	9 score on a scale Interval 9.0 to 9.0	9 score on a scale Interval 9.0 to 9.0

SECONDARY outcome

Timeframe: after birth and before hospital discharge

Rate of admission to the neonatal intensive care unit

Outcome measures

Measure	Placebo Control Group n=60 Participants Patients will receive a placebo dose of all three study medications Normal saline: Normal saline will be given intravenously, intra-muscularly, and subcutaneously in the same volume as the study drugs for the patients in the placebo group.	Multimodal Pain Regimen Group n=60 Participants Patients will receive the actual study medication for all three study medications. Intravenous acetominophen: One dose if 1 gram intravenous to be given pre-surgery Ketorolac, intramuscular: One dose of 60 mg Intramuscular to be given at time of skin closure Bupivacaine, subcutaneous: Inject 20 mL of 0.25% bupivacaine at the site of anticipated skin incision.
NICU Admission	2 Participants	6 Participants

SECONDARY outcome

Timeframe: after birth and before hospital discharge

neonate receipt of oxygen by nasal cannula or mechanical ventilation

Outcome measures

Measure	Placebo Control Group n=60 Participants Patients will receive a placebo dose of all three study medications Normal saline: Normal saline will be given intravenously, intra-muscularly, and subcutaneously in the same volume as the study drugs for the patients in the placebo group.	Multimodal Pain Regimen Group n=60 Participants Patients will receive the actual study medication for all three study medications. Intravenous acetominophen: One dose if 1 gram intravenous to be given pre-surgery Ketorolac, intramuscular: One dose of 60 mg Intramuscular to be given at time of skin closure Bupivacaine, subcutaneous: Inject 20 mL of 0.25% bupivacaine at the site of anticipated skin incision.
Need for Respiratory Support	0 Participants	4 Participants

Adverse Events

Placebo Control Group

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Multimodal Pain Regimen Group

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo Control Group n=60 participants at risk Patients will receive a placebo dose of all three study medications Normal saline: Normal saline will be given intravenously, intra-muscularly, and subcutaneously in the same volume as the study drugs for the patients in the placebo group.	Multimodal Pain Regimen Group n=60 participants at risk Patients will receive the actual study medication for all three study medications. Intravenous acetominophen: One dose if 1 gram intravenous to be given pre-surgery Ketorolac, intramuscular: One dose of 60 mg Intramuscular to be given at time of skin closure Bupivacaine, subcutaneous: Inject 20 mL of 0.25% bupivacaine at the site of anticipated skin incision.
Pregnancy, puerperium and perinatal conditions October 2016-May 2017	1.7% 1/60 • Number of events 1 • 9 months	1.7% 1/60 • Number of events 1 • 9 months
Pregnancy, puerperium and perinatal conditions October 2016-May 2018	1.7% 1/60 • Number of events 1 • 9 months	0.00% 0/60 • 9 months

Other adverse events

Measure	Placebo Control Group n=60 participants at risk Patients will receive a placebo dose of all three study medications Normal saline: Normal saline will be given intravenously, intra-muscularly, and subcutaneously in the same volume as the study drugs for the patients in the placebo group.	Multimodal Pain Regimen Group n=60 participants at risk Patients will receive the actual study medication for all three study medications. Intravenous acetominophen: One dose if 1 gram intravenous to be given pre-surgery Ketorolac, intramuscular: One dose of 60 mg Intramuscular to be given at time of skin closure Bupivacaine, subcutaneous: Inject 20 mL of 0.25% bupivacaine at the site of anticipated skin incision.
Skin and subcutaneous tissue disorders October 2016-May 2017	0.00% 0/60 • 9 months	1.7% 1/60 • Number of events 1 • 9 months
Renal and urinary disorders October 2016-May 2018	0.00% 0/60 • 9 months	1.7% 1/60 • Number of events 1 • 9 months
Cardiac disorders October 2016-May 2017	1.7% 1/60 • Number of events 1 • 9 months	0.00% 0/60 • 9 months

Additional Information

Emily Hadley

University of Texas Medical Branch

Phone: 4022028626

Email: ehadley15@gmail.com

Results disclosure agreements

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