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

February 21, 2020 updated by: Duke University
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: Ropivacaine
Drug: Ketorolac
Placebo Comparator: 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.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
24 hours after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 hours
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
24 hours
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
48 hours
Opioid Consumption
Time Frame: 2 hours
measured in mg oxycodone equivalents
2 hours
Opioid Consumption
Time Frame: 24 hours
measured in mg oxycodone equivalents
24 hours
Opioid Consumption
Time Frame: 48 hours
measured in mg oxycodone equivalents
48 hours
Time to First Rescue Analgesic
Time Frame: 48 hours
48 hours
Number of Subjects Experiencing Nausea
Time Frame: 2 hours
Asking patients whether or not they experienced the symptom in the preceding time-frame
2 hours
Number of Subjects Experiencing Nausea
Time Frame: 24 hours
Asking patients whether or not they experienced the symptom in the preceding time-frame
24 hours
Number of Subjects Experiencing Nausea
Time Frame: 48 hours
Asking patients whether or not they experienced the symptom in the preceding time-frame
48 hours
Number of Subjects Experiencing Vomiting
Time Frame: 2 hours
Asking patients whether or not they experienced the symptom in the preceding time-frame
2 hours
Number of Subjects Experiencing Vomiting
Time Frame: 24 hours
Asking patients whether or not they experienced the symptom in the preceding time-frame
24 hours
Number of Subjects Experiencing Vomiting
Time Frame: 48 hours
Asking patients whether or not they experienced the symptom in the preceding time-frame
48 hours
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
2 hours
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
24 hours
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
48 hours
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
48 hours
Number of Subjects With Chronic Pain
Time Frame: 8 weeks
Phone interview asking patient about presence of pain at incision site
8 weeks
Number of Subjects With Chronic Pain
Time Frame: 6 months
Phone interview asking patient about presence of pain at incision site
6 months
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
8 weeks
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
6 months
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
48 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ashraf Habib, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00069752

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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