Clinical trial NCT02829944: Impact of Local Anesthetic Wound Infiltration on Postoperative Pain Following Cesarean Delivery
Official title: Impact of Local Anesthetic Wound Infiltration on Postoperative Pain Following Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Cesarean section
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain Score on Movement (Sitting in Bed From a Supine Position)
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Pain Scores at Rest
timeFrame: 2 hours
measure: Pain Scores at Rest
timeFrame: 24 hours
measure: Pain Scores at Rest
timeFrame: 48 hours
measure: Opioid Consumption
timeFrame: 2 hours
measure: Opioid Consumption
timeFrame: 24 hours
measure: Opioid Consumption
timeFrame: 48 hours
measure: Time to First Rescue Analgesic
timeFrame: 48 hours
measure: Number of Subjects Experiencing Nausea
timeFrame: 2 hours
measure: Number of Subjects Experiencing Nausea
timeFrame: 24 hours
measure: Number of Subjects Experiencing Nausea
timeFrame: 48 hours
measure: Number of Subjects Experiencing Vomiting
timeFrame: 2 hours
measure: Number of Subjects Experiencing Vomiting
timeFrame: 24 hours
measure: Number of Subjects Experiencing Vomiting
timeFrame: 48 hours
measure: Number of Subjects Experiencing Pruritus
timeFrame: 2 hours
measure: Number of Subjects Experiencing Pruritus
timeFrame: 24 hours
measure: Number of Subjects Experiencing Pruritus
timeFrame: 48 hours
measure: Patient Satisfaction With Postoperative Analgesia on a 0-10 Scale
timeFrame: 48 hours
measure: Number of Subjects With Chronic Pain
timeFrame: 8 weeks
measure: Number of Subjects With Chronic Pain
timeFrame: 6 months
measure: Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale
timeFrame: 8 weeks
measure: Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale
timeFrame: 6 months
measure: Pain Score on Movement
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Duke University
name: Ashraf Habib, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.