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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014