Ketolorac Versus Saline at Laparoscopic Incision Sites

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01374828
Recruitment Status : Withdrawn (lack of funding)
First Posted : June 16, 2011
Last Update Posted : January 10, 2013
Information provided by (Responsible Party):
The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Ketolorac Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Randomized Double-blind Study of Incisional Local Anesthesia in Laparoscopic Surgery (Ketorolac Versus Normal Saline)
Study Start Date : January 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ketorolac

Arm Intervention/treatment
Experimental: Ketolorac Drug: Ketolorac
Ketorolac 30 mg in 10 ml saline will be injected at the incision sites at the conclusion of the procedure.
Other Name: Toradol

Primary Outcome Measures :
  1. Determine if ketorolac decreases incisional pain in laparoscopic surgery [ Time Frame: 60 minutes post-op, 120 minutes post-op, at D/C from PACU and 24-hours following surgery ]

Secondary Outcome Measures :
  1. Determine if amount of postoperative narcotics decreases after ketorolac use; monitor side effects and adverse outcomes [ Time Frame: 60-minutes post-op; 120 minutes post-op; at time of D/C from PACU; and 24-hours post-op ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01374828

United States, Ohio
Cleveland Clinic - Beachwood Ambulatory Surgery Center
Beachwood, Ohio, United States, 44122
Sponsors and Collaborators
The Cleveland Clinic
Principal Investigator: Jeffrey M. Goldberg, MD The Cleveland Clinic

Responsible Party: The Cleveland Clinic Identifier: NCT01374828     History of Changes
Other Study ID Numbers: 11-452
First Posted: June 16, 2011    Key Record Dates
Last Update Posted: January 10, 2013
Last Verified: January 2013

Keywords provided by The Cleveland Clinic:
Normal saline
Postoperative pain control
Incisional analgesia

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action