NCT03331315

Brief Summary

Randomized control trial between ketorolac versus celecoxib for postoperative pain following hysterectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2013

Typical duration for phase_2

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

Study Start

First participant enrolled

September 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
10 months until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
7 months until next milestone

Results Posted

Study results publicly available

June 4, 2018

Completed
Last Updated

December 7, 2023

Status Verified

November 1, 2023

Enrollment Period

2.8 years

First QC Date

April 7, 2015

Results QC Date

March 29, 2018

Last Update Submit

November 15, 2023

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Average Inpatient Postoperative Pain Score

    Pain measured using the Visual Analog Scale, no pain (0-0.4 cm), mild pain(0.5-4.4 cm), moderate pain (4.5-7.4 cm), and severe pain (7.5-10.0 cm). Subscale scoring was not used in analysis but provided as reference for patient and nursing staff.

    48 hrs following surgery

Secondary Outcomes (7)

  • Average Inpatient Hydromorphone Use

    48 hrs following surgery

  • Average Inpatient Ondansetron Use

    48 hrs following surgery

  • Total Hospital Stay

    Following surgery

  • Number of Participants With Perioperative Complications

    During and after surgery

  • Return to Activities of Daily Living

    2 weeks after discharge

  • +2 more secondary outcomes

Study Arms (2)

Ketorolac

ACTIVE COMPARATOR

Patients receiving scheduled ketorolac postoperatively

Drug: Ketorolac

Celecoxib

EXPERIMENTAL

Patients receiving celebrex preoperative and postoperatively for 7 days

Drug: Celecoxib

Interventions

CelecoxibDRUG
Celecoxib
KetorolacDRUG
Ketorolac

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing hysterectomy

You may not qualify if:

  • Coronary Artery Disease
  • Peptic Ulcer Disease
  • Chronic Renal Disease
  • Liver disease
  • Alcohol Abuse
  • Daily narcotic usage
  • Narcotic use 24 hours prior to surgery
  • Crohn's Disease
  • History of myocardial infarction
  • History of stroke
  • Preoperative hematocrit less than 24
  • Asthma
  • Ulcerative Colitis
  • Diverticulitis
  • Aspirin Allergy
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Hospital System

Memphis, Tennessee, 38104, United States

Location

Related Publications (4)

  • Azari L, Santoso JT, Osborne SE. Optimal pain management in total abdominal hysterectomy. Obstet Gynecol Surv. 2013 Mar;68(3):215-27. doi: 10.1097/OGX.0b013e31827f5119.

    PMID: 23945838BACKGROUND

  • Blanton E, Lamvu G, Patanwala I, Barron KI, Witzeman K, Tu FF, As-Sanie S. Non-opioid pain management in benign minimally invasive hysterectomy: A systematic review. Am J Obstet Gynecol. 2017 Jun;216(6):557-567. doi: 10.1016/j.ajog.2016.12.175. Epub 2016 Dec 30.

    PMID: 28043841BACKGROUND

  • Strom BL, Berlin JA, Kinman JL, Spitz PW, Hennessy S, Feldman H, Kimmel S, Carson JL. Parenteral ketorolac and risk of gastrointestinal and operative site bleeding. A postmarketing surveillance study. JAMA. 1996 Feb 7;275(5):376-82.

    PMID: 8569017BACKGROUND

  • Gong L, Thorn CF, Bertagnolli MM, Grosser T, Altman RB, Klein TE. Celecoxib pathways: pharmacokinetics and pharmacodynamics. Pharmacogenet Genomics. 2012 Apr;22(4):310-8. doi: 10.1097/FPC.0b013e32834f94cb. No abstract available.

    PMID: 22336956BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

CelecoxibKetorolac

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Michael Ulm
Organization
University of Tennessee - West Cancer Center
mulm@westclinic.com
404-281-9480

Study Officials

  • Michael A Ulm, MD

    University of Tennessee

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Priniciple Investigator

Study Record Dates

First Submitted

April 7, 2015

First Posted

November 6, 2017

Study Start

September 1, 2013

Primary Completion

June 30, 2016

Study Completion

January 1, 2017

Last Updated

December 7, 2023

Results First Posted

June 4, 2018

Record last verified: 2023-11

Locations

US(1)