Impact of Local Anesthetic Wound Infiltration on Postoperative Pain Following Cesarean Delivery

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Local Anesthetic Wound Infiltration on Postoperative Pain Following Cesarean Delivery

Conditions
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Pain

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Ketorolac
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine<br>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. | Drug: Ropivacaine<br> <br> Drug: Ketorolac<br> <br> |
| Placebo Comparator: Placebo<br>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. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean section