NCT01374828

Brief Summary

Pain control following surgery is a critical aspect of patient care. Pain at incision sites in laparoscopic surgery contributes to overall pain felt by a patient. There is no definitive proof that the typical medications (such as lidocaine) injected at incision sites during surgery improve pain control. This study looks at a different type of medication (ketorolac - an NSAID) to better control pain at laparoscopic incision sites.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
withdrawn

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

June 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 10, 2013

Status Verified

January 1, 2013

Enrollment Period

1.9 years

First QC Date

June 15, 2011

Last Update Submit

January 9, 2013

Conditions

Pain, Postoperative

Keywords

ToradolKetorolacNormal salineLaparoscopicPostoperative pain controlIncisional analgesia

Outcome Measures

Primary Outcomes (1)

  • Determine if ketorolac decreases incisional pain in laparoscopic surgery

    60 minutes post-op, 120 minutes post-op, at D/C from PACU and 24-hours following surgery

Secondary Outcomes (1)

  • Determine if amount of postoperative narcotics decreases after ketorolac use; monitor side effects and adverse outcomes

    60-minutes post-op; 120 minutes post-op; at time of D/C from PACU; and 24-hours post-op

Study Arms (1)

Ketolorac

EXPERIMENTAL
Drug: Ketolorac

Interventions

KetoloracDRUG

Ketorolac 30 mg in 10 ml saline will be injected at the incision sites at the conclusion of the procedure.

Also known as: Toradol
Ketolorac

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female undergoing gynecologic laparoscopic surgery
  • Surgeries less than 60 minutes

You may not qualify if:

  • Patients with a diagnosis of stage III or IV endometriosis, chronic pelvic pain, chronic narcotic use, allergy to anesthetics, contraindication to ketolorac
  • Robotic assisted procedures, single-port laparoscopy or conversion to laparotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic - Beachwood Ambulatory Surgery Center

Beachwood, Ohio, 44122, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jeffrey M. Goldberg, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

June 15, 2011

First Posted

June 16, 2011

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 10, 2013

Record last verified: 2013-01

Locations

US(1)