Skip to main content
OpenTrials
Completed

NCT Number: NCT02829944

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Duke University Hospital

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

Ketorolac

Drug

Placebo

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. Pain Scores at Rest

    Time frame: 2 hours

    Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable

  2. Pain Scores at Rest

    Time frame: 24 hours

    Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable

  3. Pain Scores at Rest

    Time frame: 48 hours

    Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable

  4. Opioid Consumption

    Time frame: 2 hours

    measured in mg oxycodone equivalents

  5. Opioid Consumption

    Time frame: 24 hours

    measured in mg oxycodone equivalents

  6. Opioid Consumption

    Time frame: 48 hours

    measured in mg oxycodone equivalents

  7. Time to First Rescue Analgesic

    Time frame: 48 hours

  8. Number of Subjects Experiencing Nausea

    Time frame: 2 hours

    Asking patients whether or not they experienced the symptom in the preceding time-frame

  9. Number of Subjects Experiencing Nausea

    Time frame: 24 hours

    Asking patients whether or not they experienced the symptom in the preceding time-frame

  10. Number of Subjects Experiencing Nausea

    Time frame: 48 hours

    Asking patients whether or not they experienced the symptom in the preceding time-frame

  11. Number of Subjects Experiencing Vomiting

    Time frame: 2 hours

    Asking patients whether or not they experienced the symptom in the preceding time-frame

  12. Number of Subjects Experiencing Vomiting

    Time frame: 24 hours

    Asking patients whether or not they experienced the symptom in the preceding time-frame

  13. Number of Subjects Experiencing Vomiting

    Time frame: 48 hours

    Asking patients whether or not they experienced the symptom in the preceding time-frame

  14. Number of Subjects Experiencing Pruritus

    Time frame: 2 hours

    Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable

  15. Number of Subjects Experiencing Pruritus

    Time frame: 24 hours

    Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable

  16. Number of Subjects Experiencing Pruritus

    Time frame: 48 hours

    Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable

  17. Patient Satisfaction With Postoperative Analgesia on a 0-10 Scale

    Time frame: 48 hours

    Score reported on a scale of 0-10, with 0 being not at all satisfied and 10 being completely satisfied

  18. Number of Subjects With Chronic Pain

    Time frame: 8 weeks

    Phone interview asking patient about presence of pain at incision site

  19. Number of Subjects With Chronic Pain

    Time frame: 6 months

    Phone interview asking patient about presence of pain at incision site

  20. Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale

    Time frame: 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

  21. Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale

    Time frame: 6 months

    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

  22. Pain Score on Movement

    Time frame: 48 hours after surgery

    Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 12, 2016
Registry last updated
Mar 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.