Ketolorac Versus Saline at Laparoscopic Incision Sites

This study has been withdrawn prior to enrollment.
(lack of funding)
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01374828
First received: June 15, 2011
Last updated: January 9, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Pain, Postoperative
Drug: Ketolorac
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Randomized Double-blind Study of Incisional Local Anesthesia in Laparoscopic Surgery (Ketorolac Versus Normal Saline)

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01374828

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

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01374828     History of Changes
Other Study ID Numbers: 11-452
Study First Received: June 15, 2011
Last Updated: January 9, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 20, 2014