Pain, Postoperative
Conditions
Keywords
preemptive analgesia, paracervical block, vaginal hysterectomy
Brief summary
Preemptive analgesia is an intervention which provides an anesthetic prior to initiating a painful stimulus. This trial is examining the effects of a local anesthetic given at the point of innervation prior to performing a vaginal hysterectomy with suspension sutures.
Interventions
20 ml of 0.5% bupivacaine with 1:200,000 epinephrine paracervical injection.
DRUGPlacebo
20 ml normal saline injection.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women undergoing vaginal hysterectomy with McCall's culdoplasty
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) Pain Score | 30 minutes post-op | Visual Analogue Scale (VAS) pain score on a scale from 0 (None) to 10 (Worst) points. |
Countries
United States
Participant flow
Recruitment details
Patients undergoing vaginal hysterectomy with McCall culdoplasty at the Mayo Clinic Hospital were recruited from 17 May 2006 to 14 February 2008. We screened 146 patients who were scheduled for vaginal surgery, and 142 were eligible to participate.
Pre-assignment details
95 of the eligible patients consented to participate. 3 were excluded prior to treatment because they converted to abdominal hysterectomy. 2 were excluded because the study treatment was unintentionally missed by the operating staff.
Participants by arm
| Arm | Count |
|---|---|
| Preemptive Local Analgesia (PLA) Active preemptive local analgesia. | 45 |
| Placebo Placebo for preemptive local analgesia. | 45 |
| Total | 90 |
Baseline characteristics
| Characteristic | Preemptive Local Analgesia (PLA) | Placebo | Total |
|---|---|---|---|
| Age Continuous | 57 years STANDARD_DEVIATION 15 | 54 years STANDARD_DEVIATION 20 | 56 years STANDARD_DEVIATION 18 |
| BMI | 26.2 kg/m^2 STANDARD_DEVIATION 5.4 | 25.4 kg/m^2 STANDARD_DEVIATION 4 | 25.8 kg/m^2 STANDARD_DEVIATION 4.8 |
| Sex: Female, Male Female | 45 Participants | 45 Participants | 90 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 45 | 22 / 45 |
| serious Total, serious adverse events | 5 / 45 | 3 / 45 |
Outcome results
Primary
Visual Analogue Scale (VAS) Pain Score
Visual Analogue Scale (VAS) pain score on a scale from 0 (None) to 10 (Worst) points.
Time frame: 30 minutes post-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Preemptive Local Analgesia (PLA) | Visual Analogue Scale (VAS) Pain Score | 2.5 points on a scale | Standard Deviation 3.1 |
| Placebo | Visual Analogue Scale (VAS) Pain Score | 4.4 points on a scale | Standard Deviation 3 |
p-value: 0.00395% CI: [-3.2, -0.7]t-test, 2 sided