Anesthesia and Postoperative Pain - Full Text View

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:

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

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

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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

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:

Fishbein L, O'Brien P, Hutson A, Theriaque D, Stacpoole PW, Flotte T. Pharmacokinetics and pharmacodynamic effects of nicotine nasal spray devices on cardiovascular and pulmonary function. J Investig Med. 2000 Nov;48(6):435-40.

Flood P, Ramirez-Latorre J, Role L. Alpha 4 beta 2 neuronal nicotinic acetylcholine receptors in the central nervous system are inhibited by isoflurane and propofol, but alpha 7-type nicotinic acetylcholine receptors are unaffected. Anesthesiology. 1997 Apr;86(4):859-65.

Flood P, Sonner JM, Gong D, Coates KM. Isoflurane hyperalgesia is modulated by nicotinic inhibition. Anesthesiology. 2002 Jul;97(1):192-8.

Guthrie SK, Zubieta JK, Ohl L, Ni L, Koeppe RA, Minoshima S, Domino EF. Arterial/venous plasma nicotine concentrations following nicotine nasal spray. Eur J Clin Pharmacol. 1999 Nov;55(9):639-43.

Violet JM, Downie DL, Nakisa RC, Lieb WR, Franks NP. Differential sensitivities of mammalian neuronal and muscle nicotinic acetylcholine receptors to general anesthetics. Anesthesiology. 1997 Apr;86(4):866-74.

Zhang Y, Eger EI 2nd, Dutton RC, Sonner JM. Inhaled anesthetics have hyperalgesic effects at 0.1 minimum alveolar anesthetic concentration. Anesth Analg. 2000 Aug;91(2):462-6.

Flood P, Daniel D. Intranasal nicotine for postoperative pain treatment. Anesthesiology. 2004 Dec;101(6):1417-21.

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
Nicotine polacrilex
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
Central Nervous System Stimulants

ClinicalTrials.gov processed this record on May 23, 2013