Anesthesia and Postoperative Pain

This study has been completed.
Sponsor:
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT00232817
First received: October 3, 2005
Last updated: January 12, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Postoperative Pain
Drug: Nicotine (drug)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Columbia University:

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

Secondary Outcome Measures:
  • - Cumulative morphine usage at 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 120, and 1440 minutes post-op [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • - 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 ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: July 2003
Study Completion Date: March 2006
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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: 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
Study First Received: October 3, 2005
Last Updated: January 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Columbia University:
Postoperative pain

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics
Nicotine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014