NCT02829944

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for phase_4 pain

Timeline
Completed

Started Nov 2016

Longer than P75 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
6 months until next milestone

Results Posted

Study results publicly available

March 6, 2020

Completed
Last Updated

March 6, 2020

Status Verified

February 1, 2020

Enrollment Period

2.3 years

First QC Date

July 8, 2016

Results QC Date

February 21, 2020

Last Update Submit

February 21, 2020

Conditions

Pain

Keywords

Cesarean section

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (22)

  • Pain Scores at Rest

    2 hours

  • Pain Scores at Rest

    24 hours

  • Pain Scores at Rest

    48 hours

  • Opioid Consumption

    2 hours

  • Opioid Consumption

    24 hours

  • +17 more secondary outcomes

Study Arms (2)

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.

Drug: RopivacaineDrug: 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.

Drug: Placebo

Interventions

RopivacaineDRUG
Ropivacaine
KetorolacDRUG
Ropivacaine
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

  • 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.

    PMID: 31923061DERIVED

MeSH Terms

Conditions

Pain

Interventions

RopivacaineKetorolac

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesIndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Emily Barney
Organization
Duke University Medical Center
ezb2@duke.edu
9709031869

Study Officials

  • Ashraf Habib, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2016

First Posted

July 12, 2016

Study Start

November 1, 2016

Primary Completion

March 1, 2019

Study Completion

September 1, 2019

Last Updated

March 6, 2020

Results First Posted

March 6, 2020

Record last verified: 2020-02

Locations

US(1)