Phase 4
N=23
Anesthesia and Postoperative Pain
Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT00232817 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Score on a Pain Rating Scale (Numerical Analog Score) — 1.5; 4.9 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nicotine (drug) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Columbia University
- Primary completion
- Jul 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Score on a Pain Rating Scale (Numerical Analog Score) |
1.5; 4.9 | — |
| SECONDARY Cumulative Morphine Usage |
35.3; 51.6 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00232817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.