Anesthesia and Postoperative Pain

NCT00232817 | Completed Phase 4 Results FDA Drug

• 1 other identifier: AAAA6698
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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 receive intranasal nicotine or placebo in order to detect potential 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 the 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. The investigators 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.

Conditions

Postoperative Pain

Keywords

Postoperative pain

Outcome Measures

Primary Outcomes (1)

• Score on a Pain Rating Scale (Numerical Analog Score)

  Pain was reported on the Numerical Rating Scale for pain (NRS) with 0=no pain and 10=worst pain. Pain was assessed at 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 120, and 1440 minutes post-op, and the average of all time-points is reported.

  Up to 24 hours

Secondary Outcomes (1)

• Cumulative Morphine Usage

  Up to 24 hours

Study Arms (2)

1

EXPERIMENTAL

Propofol anesthetic with and without nicotine

Drug: Nicotine (drug)

2

EXPERIMENTAL

isoflurane anesthetic with and without nicotine

Drug: Nicotine (drug)

Interventions

Nicotine (drug) DRUG

nicotine nasal spray (3mg) before surgery

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• smoking
• uncontrolled hypertension
• myocardial disease
• history of stroke

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Related Publications (7)

• 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.

  PMID: 11094866 BACKGROUND

• 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. doi: 10.1097/00000542-199704000-00016.

  PMID: 9105230 BACKGROUND

• Flood P, Sonner JM, Gong D, Coates KM. Isoflurane hyperalgesia is modulated by nicotinic inhibition. Anesthesiology. 2002 Jul;97(1):192-8. doi: 10.1097/00000542-200207000-00027.

  PMID: 12131122 BACKGROUND

• 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. doi: 10.1007/s002280050686.

  PMID: 10638392 BACKGROUND

• 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. doi: 10.1097/00000542-199704000-00017.

  PMID: 9105231 BACKGROUND

• 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. doi: 10.1097/00000539-200008000-00044.

  PMID: 10910869 BACKGROUND

• Flood P, Daniel D. Intranasal nicotine for postoperative pain treatment. Anesthesiology. 2004 Dec;101(6):1417-21. doi: 10.1097/00000542-200412000-00023.

  PMID: 15564950 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Nicotine; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Pamela Flood
• Organization: Columbia University

pamelaflood181@gmail.com

201-370-3933

Study Officials

• Pamela D Flood, M.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2005
• First Posted: October 5, 2005
• Study Start: July 1, 2003
• Primary Completion: July 1, 2005
• Study Completion: March 1, 2006
• Last Updated: July 12, 2024
• Results First Posted: July 12, 2024

Record last verified: 2024-06

Locations

US (1)