Pain
Conditions
Keywords
Cesarean section
Brief summary
The purpose of this study is to determine if the infusion of the local anesthetic ropivacaine (a numbing medicine) and the non-steroidal anti-inflammatory drug ketorolac (a pain killer similar to ibuprofen) through a catheter placed along the cesarean delivery incision, will reduce the pain experienced after cesarean section and need for narcotic pain medicine.
Interventions
DRUGRopivacaine
DRUGKetorolac
DRUGPlacebo
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiology (ASA) class 1,2, and 3 * English speaking women at a gestational age \> 37 weeks * scheduled for cesarean delivery under spinal or combined spinal epidural anesthesia
Exclusion criteria
* BMI \> 50 kg/m2 * history of intravenous drug or opioid abuse * previous history of chronic pain syndrome * history of opioid use in the past week * allergy or contraindication to any of the study medications * non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score on Movement (Sitting in Bed From a Supine Position) | 24 hours after surgery | Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | 2 hours | measured in mg oxycodone equivalents |
| Time to First Rescue Analgesic | 48 hours | — |
| Number of Subjects Experiencing Nausea | 2 hours | Asking patients whether or not they experienced the symptom in the preceding time-frame |
| Number of Subjects Experiencing Vomiting | 2 hours | Asking patients whether or not they experienced the symptom in the preceding time-frame |
| Pain Scores at Rest | 2 hours | Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable |
| Patient Satisfaction With Postoperative Analgesia on a 0-10 Scale | 48 hours | Score reported on a scale of 0-10, with 0 being not at all satisfied and 10 being completely satisfied |
| Number of Subjects With Chronic Pain | 8 weeks | Phone interview asking patient about presence of pain at incision site |
| Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale | 8 weeks | 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 |
| Pain Score on Movement | 48 hours after surgery | Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable |
| Number of Subjects Experiencing Pruritus | 2 hours | Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable |
Countries
United States
Participant flow
Recruitment details
This study recruited participants from the Duke Labor and Delivery population, as they presented for scheduled Cesarean Delivery.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 38 |
| 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 | 33 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Catheter broke | 0 | 1 |
| Overall Study | Catheter Displacement | 1 | 0 |
| Overall Study | Inadequate Neuraxial Block | 1 | 1 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Screen Failure | 2 | 2 |
| Overall Study | Staff unavailable | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Placebo | Total | Ropivacaine |
|---|---|---|---|
| Age, Continuous Age | 31.5 years | 31 years | 30 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 37 Participants | 68 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 24 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 40 Participants | 18 Participants |
| Region of Enrollment United States | 38 participants | 71 participants | 33 participants |
| Sex: Female, Male Female | 38 Participants | 71 Participants | 33 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 33 |
| other Total, other adverse events | 20 / 38 | 18 / 33 |
| serious Total, serious adverse events | 0 / 38 | 0 / 33 |
Outcome results
Primary
Pain Score on Movement (Sitting in Bed From a Supine Position)
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Time frame: 24 hours after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Pain Score on Movement (Sitting in Bed From a Supine Position) | 5 score on a scale |
| Ropivacaine | Pain Score on Movement (Sitting in Bed From a Supine Position) | 5 score on a scale |
Secondary
Number of Subjects Experiencing Nausea
Asking patients whether or not they experienced the symptom in the preceding time-frame
Time frame: 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Subjects Experiencing Nausea | 4 Participants |
| Ropivacaine | Number of Subjects Experiencing Nausea | 1 Participants |
Secondary
Number of Subjects Experiencing Nausea
Asking patients whether or not they experienced the symptom in the preceding time-frame
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Subjects Experiencing Nausea | 9 Participants |
| Ropivacaine | Number of Subjects Experiencing Nausea | 7 Participants |
Secondary
Number of Subjects Experiencing Nausea
Asking patients whether or not they experienced the symptom in the preceding time-frame
Time frame: 2 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Subjects Experiencing Nausea | 14 Participants |
| Ropivacaine | Number of Subjects Experiencing Nausea | 12 Participants |
Secondary
Number of Subjects Experiencing Pruritus
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Time frame: 2 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Number of Subjects Experiencing Pruritus | 4 score on a scale |
| Ropivacaine | Number of Subjects Experiencing Pruritus | 5.5 score on a scale |
Secondary
Number of Subjects Experiencing Pruritus
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Time frame: 48 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Number of Subjects Experiencing Pruritus | 0 score on a scale |
| Ropivacaine | Number of Subjects Experiencing Pruritus | 0 score on a scale |
Secondary
Number of Subjects Experiencing Pruritus
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Number of Subjects Experiencing Pruritus | 3.5 units on a scale |
| Ropivacaine | Number of Subjects Experiencing Pruritus | 4 units on a scale |
Secondary
Number of Subjects Experiencing Vomiting
Asking patients whether or not they experienced the symptom in the preceding time-frame
Time frame: 2 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Subjects Experiencing Vomiting | 7 Participants |
| Ropivacaine | Number of Subjects Experiencing Vomiting | 8 Participants |
Secondary
Number of Subjects Experiencing Vomiting
Asking patients whether or not they experienced the symptom in the preceding time-frame
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Subjects Experiencing Vomiting | 4 Participants |
| Ropivacaine | Number of Subjects Experiencing Vomiting | 4 Participants |
Secondary
Number of Subjects Experiencing Vomiting
Asking patients whether or not they experienced the symptom in the preceding time-frame
Time frame: 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Subjects Experiencing Vomiting | 1 Participants |
| Ropivacaine | Number of Subjects Experiencing Vomiting | 0 Participants |
Secondary
Number of Subjects With Chronic Pain
Phone interview asking patient about presence of pain at incision site
Time frame: 6 months
Population: 28 participants in each group (Placebo and Ropivacaine) did not complete the interview.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Subjects With Chronic Pain | 0 Participants |
| Ropivacaine | Number of Subjects With Chronic Pain | 0 Participants |
Secondary
Number of Subjects With Chronic Pain
Phone interview asking patient about presence of pain at incision site
Time frame: 8 weeks
Population: Unable to make contact with 9 participants in the Placebo group and 13 participants in the Ropivacaine group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Subjects With Chronic Pain | 3 Participants |
| Ropivacaine | Number of Subjects With Chronic Pain | 3 Participants |
Secondary
Opioid Consumption
measured in mg oxycodone equivalents
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Opioid Consumption | 5 mg Oxycodone Equivalent |
| Ropivacaine | Opioid Consumption | 5 mg Oxycodone Equivalent |
Secondary
Opioid Consumption
measured in mg oxycodone equivalents
Time frame: 2 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Opioid Consumption | 0 mg Oxycodone Equivalent |
| Ropivacaine | Opioid Consumption | 0 mg Oxycodone Equivalent |
Secondary
Opioid Consumption
measured in mg oxycodone equivalents
Time frame: 48 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Opioid Consumption | 20 mg Oxycodone Equivalent |
| Ropivacaine | Opioid Consumption | 10 mg Oxycodone Equivalent |
Secondary
Pain Score on Movement
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Time frame: 48 hours after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Pain Score on Movement | 5.5 score on a scale |
| Ropivacaine | Pain Score on Movement | 5 score on a scale |
Secondary
Pain Scores at Rest
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Time frame: 2 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Pain Scores at Rest | 2 score on a scale |
| Ropivacaine | Pain Scores at Rest | 0 score on a scale |
Secondary
Pain Scores at Rest
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Time frame: 24 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Pain Scores at Rest | 2 score on a scale |
| Ropivacaine | Pain Scores at Rest | 2 score on a scale |
Secondary
Pain Scores at Rest
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Time frame: 48 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Pain Scores at Rest | 2 score on a scale |
| Ropivacaine | Pain Scores at Rest | 2 score on a scale |
Secondary
Patient Satisfaction With Postoperative Analgesia on a 0-10 Scale
Score reported on a scale of 0-10, with 0 being not at all satisfied and 10 being completely satisfied
Time frame: 48 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Patient Satisfaction With Postoperative Analgesia on a 0-10 Scale | 9.5 score on a scale |
| Ropivacaine | Patient Satisfaction With Postoperative Analgesia on a 0-10 Scale | 8 score on a scale |
Secondary
Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale
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
Time frame: 6 months
Population: Unable to make contact with 19 participants in the Placebo group and 22 participants in the Ropivacaine group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale | 3 Participants |
| Ropivacaine | Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale | 1 Participants |
Secondary
Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale
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
Time frame: 8 weeks
Population: Unable to make contact with 9 participants in the Placebo group and 13 participants in the Ropivacaine group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale | 1 units on a scale |
| Ropivacaine | Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale | 0.5 units on a scale |
Secondary
Time to First Rescue Analgesic
Time frame: 48 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Time to First Rescue Analgesic | 660 Minutes |
| Ropivacaine | Time to First Rescue Analgesic | 954 Minutes |