PainPhase 4NCT02829944
Impact of Local Anesthetic Wound Infiltration on Postoperative Pain Following Cesarean Delivery
A Phase 4 study testing Ropivacaine and Ketorolac in people with Pain, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain
- What is being tested?
- Ropivacaine and Ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Sep 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27705
About this study
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.
- Conditions
- Pain
- Being tested
- Ropivacaine, Ketorolac, Placebo
- Keywords
- Cesarean section
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
KetorolacDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ropivacaine; Drug: Ketorolac |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours after surgery
Secondary outcomes (22)
Pain Scores at Rest
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Measured: 2 hours
Pain Scores at Rest
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Measured: 24 hours
Pain Scores at Rest
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Measured: 48 hours
Opioid Consumption
measured in mg oxycodone equivalents
Measured: 2 hours
Opioid Consumption
measured in mg oxycodone equivalents
Measured: 24 hours
Opioid Consumption
measured in mg oxycodone equivalents
Measured: 48 hours
Time to First Rescue Analgesic
Measured: 48 hours
Number of Subjects Experiencing Nausea
Asking patients whether or not they experienced the symptom in the preceding time-frame
Measured: 2 hours
Number of Subjects Experiencing Nausea
Asking patients whether or not they experienced the symptom in the preceding time-frame
Measured: 24 hours
Number of Subjects Experiencing Nausea
Asking patients whether or not they experienced the symptom in the preceding time-frame
Measured: 48 hours
Number of Subjects Experiencing Vomiting
Asking patients whether or not they experienced the symptom in the preceding time-frame
Measured: 2 hours
Number of Subjects Experiencing Vomiting
Asking patients whether or not they experienced the symptom in the preceding time-frame
Measured: 24 hours
Number of Subjects Experiencing Vomiting
Asking patients whether or not they experienced the symptom in the preceding time-frame
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 48 hours
Number of Subjects With Chronic Pain
Phone interview asking patient about presence of pain at incision site
Measured: 8 weeks
Number of Subjects With Chronic Pain
Phone interview asking patient about presence of pain at incision site
Measured: 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
Measured: 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
Measured: 6 months
Pain Score on Movement
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashraf Habib, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829944
- Sponsor's protocol ID
- Pro00069752
- Status last verified
- Feb 2020
- First submitted
- 8 Jul 2016
- Last updated
- 6 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 31923061
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Local Anesthetic Wound Infiltration on Postoperative Pain Following Cesarean Delivery
- ClinicalTrials.gov ID
- NCT02829944
- Acronym / sponsor ID
- Pro00069752
- Conditions
- Pain
- Keywords
- Cesarean section
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Posted 6 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | Experimental | Drug: Ropivacaine, Drug: KetorolacSubjects 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 | Drug: PlaceboSubjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine | Drug | Ropivacaine |
| Ketorolac | Drug | Ropivacaine |
| Placebo | Drug | Placebo |
Primary outcome
Pain Score on Movement (Sitting in Bed From a Supine Position)
Time frame: 24 hours after surgery
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
22 secondary outcomes
Pain Scores at Rest
Time frame: 2 hours
Pain Scores at Rest
Time frame: 24 hours
Pain Scores at Rest
Time frame: 48 hours
Opioid Consumption
Time frame: 2 hours
Opioid Consumption
Time frame: 24 hours
Opioid Consumption
Time frame: 48 hours
Time to First Rescue Analgesic
Time frame: 48 hours
Number of Subjects Experiencing Nausea
Time frame: 2 hours
Number of Subjects Experiencing Nausea
Time frame: 24 hours
Number of Subjects Experiencing Nausea
Time frame: 48 hours
Number of Subjects Experiencing Vomiting
Time frame: 2 hours
Number of Subjects Experiencing Vomiting
Time frame: 24 hours
Number of Subjects Experiencing Vomiting
Time frame: 48 hours
Number of Subjects Experiencing Pruritus
Time frame: 2 hours
Number of Subjects Experiencing Pruritus
Time frame: 24 hours
Number of Subjects Experiencing Pruritus
Time frame: 48 hours
Patient Satisfaction With Postoperative Analgesia on a 0-10 Scale
Time frame: 48 hours
Number of Subjects With Chronic Pain
Time frame: 8 weeks
Number of Subjects With Chronic Pain
Time frame: 6 months
Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale
Time frame: 8 weeks
Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale
Time frame: 6 months
Pain Score on Movement
Time frame: 48 hours after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31923061Barney 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashraf Habib, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine and Ketorolac in people with Pain, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score on Movement (Sitting in Bed From a Supine Position) (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02829944, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.