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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug |
| ||
| Ketorolac |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores at Rest | Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable | 2 hours |
| Pain Scores at Rest | Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashraf Habib, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31923061 | Derived | Barney EZ, Pedro CD, Gamez BH, Fuller ME, Dominguez JE, Habib AS. Ropivacaine and Ketorolac Wound Infusion for Post-Cesarean Delivery Analgesia: A Randomized Controlled Trial. Obstet Gynecol. 2020 Feb;135(2):427-435. doi: 10.1097/AOG.0000000000003601. |
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This study recruited participants from the Duke Labor and Delivery population, as they presented for scheduled Cesarean Delivery.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Ropivacaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Median | Inter-Quartile Range | score on a scale | 24 hours after surgery |
|
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Barney | Duke University Medical Center | 9709031869 | ezb2@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 26, 2018 | Feb 14, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 9, 2016 | Feb 21, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| Placebo | Drug |
|
| 24 hours |
| Pain Scores at Rest | Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable | 48 hours |
| Opioid Consumption | measured in mg oxycodone equivalents | 2 hours |
| Opioid Consumption | measured in mg oxycodone equivalents | 24 hours |
| Opioid Consumption | measured in mg oxycodone equivalents | 48 hours |
| Time to First Rescue Analgesic | 48 hours |
| Number of Subjects Experiencing Nausea | Asking patients whether or not they experienced the symptom in the preceding time-frame | 2 hours |
| Number of Subjects Experiencing Nausea | Asking patients whether or not they experienced the symptom in the preceding time-frame | 24 hours |
| Number of Subjects Experiencing Nausea | Asking patients whether or not they experienced the symptom in the preceding time-frame | 48 hours |
| Number of Subjects Experiencing Vomiting | Asking patients whether or not they experienced the symptom in the preceding time-frame | 2 hours |
| Number of Subjects Experiencing Vomiting | Asking patients whether or not they experienced the symptom in the preceding time-frame | 24 hours |
| Number of Subjects Experiencing Vomiting | Asking patients whether or not they experienced the symptom in the preceding time-frame | 48 hours |
| Number of Subjects Experiencing Pruritus | Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable | 2 hours |
| Number of Subjects Experiencing Pruritus | Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable | 24 hours |
| Number of Subjects Experiencing Pruritus | Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable | 48 hours |
| 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 | 48 hours |
| Number of Subjects With Chronic Pain | Phone interview asking patient about presence of pain at incision site | 8 weeks |
| Number of Subjects With Chronic Pain | Phone interview asking patient about presence of pain at incision site | 6 months |
| 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 | 8 weeks |
| 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 | 6 months |
| Pain Score on Movement | Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable | 48 hours after surgery |
| Inadequate Neuraxial Block |
|
| Withdrawal by Subject |
|
| Catheter Displacement |
|
| Catheter broke |
|
| Staff unavailable |
|
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Pain Scores at Rest | Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable | Posted | Median | Inter-Quartile Range | score on a scale | 2 hours |
|
|
|
| Secondary | Pain Scores at Rest | Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable | Posted | Mean | Inter-Quartile Range | score on a scale | 24 hours |
|
|
|
| Secondary | Pain Scores at Rest | Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable | Posted | Median | Inter-Quartile Range | score on a scale | 48 hours |
|
|
|
| Secondary | Opioid Consumption | measured in mg oxycodone equivalents | Posted | Median | Inter-Quartile Range | mg Oxycodone Equivalent | 2 hours |
|
|
|
| Secondary | Opioid Consumption | measured in mg oxycodone equivalents | Posted | Median | Inter-Quartile Range | mg Oxycodone Equivalent | 24 hours |
|
|
|
| Secondary | Opioid Consumption | measured in mg oxycodone equivalents | Posted | Mean | Inter-Quartile Range | mg Oxycodone Equivalent | 48 hours |
|
|
|
| Secondary | Time to First Rescue Analgesic | Posted | Mean | Inter-Quartile Range | Minutes | 48 hours |
|
|
|
| Secondary | Number of Subjects Experiencing Nausea | Asking patients whether or not they experienced the symptom in the preceding time-frame | Posted | Count of Participants | Participants | 2 hours |
|
|
|
| Secondary | Number of Subjects Experiencing Nausea | Asking patients whether or not they experienced the symptom in the preceding time-frame | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Secondary | Number of Subjects Experiencing Nausea | Asking patients whether or not they experienced the symptom in the preceding time-frame | Posted | Count of Participants | Participants | 48 hours |
|
|
|
| Secondary | Number of Subjects Experiencing Vomiting | Asking patients whether or not they experienced the symptom in the preceding time-frame | Posted | Count of Participants | Participants | 2 hours |
|
|
|
| Secondary | Number of Subjects Experiencing Vomiting | Asking patients whether or not they experienced the symptom in the preceding time-frame | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Secondary | Number of Subjects Experiencing Vomiting | Asking patients whether or not they experienced the symptom in the preceding time-frame | Posted | Count of Participants | Participants | 48 hours |
|
|
|
| Secondary | Number of Subjects Experiencing Pruritus | Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable | Posted | Median | Inter-Quartile Range | score on a scale | 2 hours |
|
|
|
| Secondary | Number of Subjects Experiencing Pruritus | Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable | Posted | Median | Inter-Quartile Range | units on a scale | 24 hours |
|
|
|
| Secondary | Number of Subjects Experiencing Pruritus | Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable | Posted | Mean | Inter-Quartile Range | score on a scale | 48 hours |
|
|
|
| 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 | Posted | Median | Inter-Quartile Range | score on a scale | 48 hours |
|
|
|
| Secondary | Number of Subjects With Chronic Pain | Phone interview asking patient about presence of pain at incision site | Unable to make contact with 9 participants in the Placebo group and 13 participants in the Ropivacaine group. | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Secondary | Number of Subjects With Chronic Pain | Phone interview asking patient about presence of pain at incision site | 28 participants in each group (Placebo and Ropivacaine) did not complete the interview. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 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 | Unable to make contact with 9 participants in the Placebo group and 13 participants in the Ropivacaine group. | Posted | Median | Inter-Quartile Range | units on a scale | 8 weeks |
|
|
|
| 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 | Unable to make contact with 19 participants in the Placebo group and 22 participants in the Ropivacaine group. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Pain Score on Movement | Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable | Posted | Median | Inter-Quartile Range | score on a scale | 48 hours after surgery |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 20 |
| 38 |
| EG001 | 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 | 0 | 33 | 0 | 33 | 18 | 33 |
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D000588 |
| Amines |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |