Trial Outcomes & Findings for Impact of Local Anesthetic Wound Infiltration on Postoperative Pain Following Cesarean Delivery (NCT NCT02829944)
NCT ID: NCT02829944
Last Updated: 2020-03-06
Results Overview
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
84 participants
Primary outcome timeframe
24 hours after surgery
Results posted on
2020-03-06
Participant Flow
This study recruited participants from the Duke Labor and Delivery population, as they presented for scheduled Cesarean Delivery.
Participant milestones
| Measure |
Placebo
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
40
|
|
Overall Study
COMPLETED
|
38
|
33
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
Placebo
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Screen Failure
|
2
|
2
|
|
Overall Study
Inadequate Neuraxial Block
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Catheter Displacement
|
1
|
0
|
|
Overall Study
Catheter broke
|
0
|
1
|
|
Overall Study
Staff unavailable
|
0
|
1
|
Baseline Characteristics
Impact of Local Anesthetic Wound Infiltration on Postoperative Pain Following Cesarean Delivery
Baseline characteristics by cohort
| Measure |
Placebo
n=38 Participants
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
n=33 Participants
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age
|
31.5 years
n=99 Participants
|
30 years
n=107 Participants
|
31 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
37 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=99 Participants
|
33 participants
n=107 Participants
|
71 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 hours after surgeryScore reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Outcome measures
| Measure |
Placebo
n=38 Participants
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
n=33 Participants
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
|---|---|---|
|
Pain Score on Movement (Sitting in Bed From a Supine Position)
|
5 score on a scale
Interval 3.0 to 7.0
|
5 score on a scale
Interval 4.0 to 6.0
|
SECONDARY outcome
Timeframe: 2 hoursScore reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Outcome measures
| Measure |
Placebo
n=38 Participants
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
n=33 Participants
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
|---|---|---|
|
Pain Scores at Rest
|
2 score on a scale
Interval 0.0 to 3.0
|
0 score on a scale
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: 24 hoursScore reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Outcome measures
| Measure |
Placebo
n=38 Participants
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
n=33 Participants
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
|---|---|---|
|
Pain Scores at Rest
|
2 score on a scale
Interval 0.0 to 3.0
|
2 score on a scale
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: 48 hoursScore reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Outcome measures
| Measure |
Placebo
n=38 Participants
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
n=33 Participants
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
|---|---|---|
|
Pain Scores at Rest
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: 2 hoursmeasured in mg oxycodone equivalents
Outcome measures
| Measure |
Placebo
n=38 Participants
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
n=33 Participants
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
|---|---|---|
|
Opioid Consumption
|
0 mg Oxycodone Equivalent
Interval 0.0 to 0.0
|
0 mg Oxycodone Equivalent
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 24 hoursmeasured in mg oxycodone equivalents
Outcome measures
| Measure |
Placebo
n=38 Participants
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
n=33 Participants
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
|---|---|---|
|
Opioid Consumption
|
5 mg Oxycodone Equivalent
Interval 0.0 to 15.0
|
5 mg Oxycodone Equivalent
Interval 0.0 to 15.0
|
SECONDARY outcome
Timeframe: 48 hoursmeasured in mg oxycodone equivalents
Outcome measures
| Measure |
Placebo
n=38 Participants
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
n=33 Participants
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
|---|---|---|
|
Opioid Consumption
|
20 mg Oxycodone Equivalent
Interval 10.0 to 35.0
|
10 mg Oxycodone Equivalent
Interval 0.0 to 30.0
|
SECONDARY outcome
Timeframe: 48 hoursOutcome measures
| Measure |
Placebo
n=38 Participants
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
n=33 Participants
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
|---|---|---|
|
Time to First Rescue Analgesic
|
660 Minutes
Interval 99.0 to 1496.0
|
954 Minutes
Interval 244.0 to 1710.0
|
SECONDARY outcome
Timeframe: 2 hoursAsking patients whether or not they experienced the symptom in the preceding time-frame
Outcome measures
| Measure |
Placebo
n=38 Participants
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
n=33 Participants
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
|---|---|---|
|
Number of Subjects Experiencing Nausea
|
14 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 24 hoursAsking patients whether or not they experienced the symptom in the preceding time-frame
Outcome measures
| Measure |
Placebo
n=38 Participants
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
n=33 Participants
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
|---|---|---|
|
Number of Subjects Experiencing Nausea
|
9 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 48 hoursAsking patients whether or not they experienced the symptom in the preceding time-frame
Outcome measures
| Measure |
Placebo
n=38 Participants
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
n=33 Participants
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
|---|---|---|
|
Number of Subjects Experiencing Nausea
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 hoursAsking patients whether or not they experienced the symptom in the preceding time-frame
Outcome measures
| Measure |
Placebo
n=38 Participants
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
n=33 Participants
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
|---|---|---|
|
Number of Subjects Experiencing Vomiting
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 24 hoursAsking patients whether or not they experienced the symptom in the preceding time-frame
Outcome measures
| Measure |
Placebo
n=38 Participants
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
n=33 Participants
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
|---|---|---|
|
Number of Subjects Experiencing Vomiting
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 48 hoursAsking patients whether or not they experienced the symptom in the preceding time-frame
Outcome measures
| Measure |
Placebo
n=38 Participants
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
n=33 Participants
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
|---|---|---|
|
Number of Subjects Experiencing Vomiting
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 hoursScore reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Outcome measures
| Measure |
Placebo
n=38 Participants
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
n=33 Participants
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
|---|---|---|
|
Number of Subjects Experiencing Pruritus
|
4 score on a scale
Interval 1.0 to 7.0
|
5.5 score on a scale
Interval 3.5 to 8.0
|
SECONDARY outcome
Timeframe: 24 hoursScore reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Outcome measures
| Measure |
Placebo
n=38 Participants
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
n=33 Participants
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
|---|---|---|
|
Number of Subjects Experiencing Pruritus
|
3.5 units on a scale
Interval 0.0 to 7.0
|
4 units on a scale
Interval 1.0 to 8.0
|
SECONDARY outcome
Timeframe: 48 hoursScore reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Outcome measures
| Measure |
Placebo
n=38 Participants
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
n=33 Participants
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
|---|---|---|
|
Number of Subjects Experiencing Pruritus
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 48 hoursScore reported on a scale of 0-10, with 0 being not at all satisfied and 10 being completely satisfied
Outcome measures
| Measure |
Placebo
n=38 Participants
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
n=33 Participants
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
|---|---|---|
|
Patient Satisfaction With Postoperative Analgesia on a 0-10 Scale
|
9.5 score on a scale
Interval 8.0 to 10.0
|
8 score on a scale
Interval 8.0 to 9.5
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Unable to make contact with 9 participants in the Placebo group and 13 participants in the Ropivacaine group.
Phone interview asking patient about presence of pain at incision site
Outcome measures
| Measure |
Placebo
n=29 Participants
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
n=20 Participants
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
|---|---|---|
|
Number of Subjects With Chronic Pain
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 28 participants in each group (Placebo and Ropivacaine) did not complete the interview.
Phone interview asking patient about presence of pain at incision site
Outcome measures
| Measure |
Placebo
n=10 Participants
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
n=5 Participants
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
|---|---|---|
|
Number of Subjects With Chronic Pain
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Unable to make contact with 9 participants in the Placebo group and 13 participants in the Ropivacaine group.
Patients contacted over the phone completed screening with the EPDS, on a scale of 0-30. A score of over 13 indicate risk for postpartum depression
Outcome measures
| Measure |
Placebo
n=29 Participants
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
n=20 Participants
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
|---|---|---|
|
Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale
|
1 units on a scale
Interval 0.0 to 4.0
|
0.5 units on a scale
Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Unable to make contact with 19 participants in the Placebo group and 22 participants in the Ropivacaine group.
Patients contacted over the phone completed screening with the EPDS, on a scale of 0-30. A score of over 13 indicate risk for postpartum depression
Outcome measures
| Measure |
Placebo
n=19 Participants
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
n=11 Participants
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
|---|---|---|
|
Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 48 hours after surgeryScore reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Outcome measures
| Measure |
Placebo
n=38 Participants
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
n=33 Participants
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
|---|---|---|
|
Pain Score on Movement
|
5.5 score on a scale
Interval 3.0 to 8.0
|
5 score on a scale
Interval 4.0 to 6.0
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Ropivacaine
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=38 participants at risk
Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Placebo
|
Ropivacaine
n=33 participants at risk
Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.
Ropivacaine
Ketorolac
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
47.4%
18/38 • From Anesthesia start to 48 hours postoperatively.
Patients were asked at 2 hours, 24 hours and 48 hours to rate any symptoms on a scale of 0-10, with 0 being none at all and 10 being the worst imaginable symptom
|
48.5%
16/33 • From Anesthesia start to 48 hours postoperatively.
Patients were asked at 2 hours, 24 hours and 48 hours to rate any symptoms on a scale of 0-10, with 0 being none at all and 10 being the worst imaginable symptom
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
52.6%
20/38 • From Anesthesia start to 48 hours postoperatively.
Patients were asked at 2 hours, 24 hours and 48 hours to rate any symptoms on a scale of 0-10, with 0 being none at all and 10 being the worst imaginable symptom
|
54.5%
18/33 • From Anesthesia start to 48 hours postoperatively.
Patients were asked at 2 hours, 24 hours and 48 hours to rate any symptoms on a scale of 0-10, with 0 being none at all and 10 being the worst imaginable symptom
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place