Phase 4 Completed N=23 Randomized Triple-blind Treatment

Anesthesia and Postoperative Pain

Postoperative Pain

Source: ClinicalTrials.gov NCT00232817 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2024

Primary outcomePrimary: Score on a Pain Rating Scale (Numerical Analog Score) — 1.5; 4.9 scores on a scale

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.