We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Anesthesia and Postoperative Pain

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.
ClinicalTrials.gov Identifier: NCT00232817
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : January 14, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:

The purpose of this study is to compare post-operative pain after anesthesia with either isoflurane or propofol. Each group will be further randomized to recieve intranasal nicotine or placebo inorder to detect potetial pronociceptive action of isoflurane.

The study is a randomized, prospective, double-blinded controlled trial. Eighty adult women undergoing uterine surgery will be recruited for this study. Enrollment in this study is limited to women, because our animal studies suggest that females have a greater hyperalgesic response to volatile anesthetics than do males.

The patient will be given one of two standard anesthetics for their surgery: isoflurane or propofol. We are interested in these two anesthetics because we seek to see if there exists a difference in their effects on a patient's perception of pain, as has been shown to be the case in animal studies but has not yet been studied in humans.

The primary outcome variable will be postoperative pain, as measured by a numerical analog pain score (VAS) at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 120, and 1440 minutes postoperatively. Secondary outcome measures will include morphine utilization via PCA and hemodynamics variables including heart rate, systolic BP, and diastolic BP, all of which will be measured at the same time points as the VAS score.


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Nicotine (drug) Phase 4

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intranasal Nicotine for Postoperative Pain Treatment: A Comparison of Its Effects in the Context of Isoflurane-induced Anesthesia Versus Propofol Anesthesia
Study Start Date : July 2003
Primary Completion Date : July 2005
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Propofol anesthetic with and without nicotine
Drug: Nicotine (drug)
nicotine nasal spray (3mg) before surgery
Experimental: 2
isoflurane anesthetic with and without nicotine
Drug: Nicotine (drug)
nicotine nasal spray (3mg) before surgery


Outcome Measures

Primary Outcome Measures :
  1. - Score on a pain rating scale (numerical analog score) at 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 120, and 1440 minutes post-op [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. - Cumulative morphine usage at 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 120, and 1440 minutes post-op [ Time Frame: 24 hours ]
  2. - Heart rate and blood pressure at 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 120, and 1440 minutes post-op [ Time Frame: 24 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • greater than or equal to 18 years of age
  • female sex
  • present to New York Presbyterian Hospital for open pelvic surgery

Exclusion Criteria:

  • smoking
  • uncontrolled hypertension
  • myocardial disease
  • history of stroke
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00232817


Locations
United States, New York
New York Presbyterian Hospital
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Pamela D Flood, M.D. Columbia University
More Information

Publications:
Responsible Party: Pamela Flood, Principal Investigator, Columbia University Medical Center
ClinicalTrials.gov Identifier: NCT00232817     History of Changes
Other Study ID Numbers: AAAA6698
First Posted: October 5, 2005    Key Record Dates
Last Update Posted: January 14, 2011
Last Verified: January 2011

Keywords provided by Columbia University:
Postoperative pain

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Nicotine
Isoflurane
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants