Pain Relief, Analgesia
Conditions
Keywords
Hysterosalpingogram, HSG, Pain relief, Analgesia, Benzocaine
Brief summary
The objective of this study is to assess the utility of benzocaine spray versus a placebo spray in alleviating pain during and after hysterosalpingogram (HSG).
Detailed description
Hysterosalpingography (HSG) is a radiographic evaluation during which a radio-opaque medium is inserted through the cervical canal in order to define the size and shape of the uterine cavity and patency of the fallopian tubes. The utility of HSG is an integral part of the evaluation of infertile women for intrauterine pathology. In some cases, HSG can be a painful procedure. Poor pain control can limit the quality of the study due to inability to complete the procedure in cases of extreme discomfort. There is little consensus regarding pain control during HSG, although a number of approaches have been studied. Patients undergoing HSG are typically advised to premedicate with ibuprofen, which is consistent with the current standard of care. This study will assess pain control using a benzocaine spray (in addition to ibuprofen) in patients undergoing routine HSG at the Hospital of the University of Pennsylvania. All patients who present to the Hospital of the University of Pennsylvania for HSG will be eligible for the study. Benzocaine spray versus a placebo spray will be applied to a tenaculum (a surgical hooklike instrument used to grasp and hold the cervix). The tenaculum will then be applied to the cervix prior to HSG and pain relief will be assessed at 3 time intervals: 0, 5, and 30 minutes. The primary outcome is the mean difference in patients pain score and will be measured using the Visual Analogue Scale (VAS) which has been shown to be a valid and reliable scale. The secondary outcome will assess patient satisfaction in each group using a validated patient satisfaction survey. The study design will be prospective, randomized, placebo controlled, and double blinded.
Interventions
DRUGBenzocaine
DRUGSaline spray
A saline spray will be used in the placebo group
Sponsors
University of Pennsylvania
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
Yes
Inclusion criteria
* All women who present to Penn Fertility Care over the age of 18 years old
Exclusion criteria
* Patients under the age of 18 * Pregnant patients * Patients with a history of hypersensitivity to benzocaine * Patients with a history of asthma or bronchitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Score | Pre-procedure (Baseline) and procedure (Time 0) | The primary outcome is the difference in pain score using a validated visual analog scale before the procedure, which is designated as the pre-procedure (or baseline) pain score to the maximum pain during procedure (designated as time 0) These two pain scores will be subtracted and the change in pain score will be reported. The validated visual analog scale allows patients to report pain on a scale of 0 to 100 mm long. At the beginning and at the end, there are two descriptors representing extremes of pain (i.e. no pain = 0 and extreme pain = 100). The patient rated her pain by making a vertical mark on the 100-mm line. The measurement in millimeters was converted to the same number of points ranging from 0 to 100 points. There are no subgroups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 30 minutes post procedure | The patient's satisfaction will be assessed using a validated satisfaction scale 30 minutes post procedure. |
| Change in Pain Score From Pre-procedure to 5 Minutes Post Procedure. | 5 minutes | The patients pain scores will also be assessed at 5 minutes post procedure and the change in pain scores from baseline to this time points will be analyzed. The pain scores will be subtracted to obtain the change in pain score |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Benzocaine Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.
Benzocaine | 15 |
| Saline Spray A saline placebo spray will be used in the placebo group.
Saline spray: A saline spray will be used in the placebo group | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Benzocaine | Total | Saline Spray |
|---|---|---|---|
| Age, Continuous | 34.3 years STANDARD_DEVIATION 4.8 | 33.9 years STANDARD_DEVIATION 5.7 | 33.3 years STANDARD_DEVIATION 6.5 |
| Bilateral obstruction | 2 participants | 3 participants | 1 participants |
| History of chronic pelvic pain | 2 participants | 4 participants | 2 participants |
| History of dysmenorrhea | 7 participants | 13 participants | 6 participants |
| Nulligravid | 7 participants | 17 participants | 10 participants |
| Nulliparous | 12 participants | 24 participants | 12 participants |
| Pre-medication | 15 participants | 28 participants | 13 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 11 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 14 Participants | 6 Participants |
| Region of Enrollment United States | 15 participants | 30 participants | 15 participants |
| Sex: Female, Male Female | 15 Participants | 30 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Unilateral obstruction | 4 participants | 7 participants | 3 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Change in Pain Score
The primary outcome is the difference in pain score using a validated visual analog scale before the procedure, which is designated as the pre-procedure (or baseline) pain score to the maximum pain during procedure (designated as time 0) These two pain scores will be subtracted and the change in pain score will be reported. The validated visual analog scale allows patients to report pain on a scale of 0 to 100 mm long. At the beginning and at the end, there are two descriptors representing extremes of pain (i.e. no pain = 0 and extreme pain = 100). The patient rated her pain by making a vertical mark on the 100-mm line. The measurement in millimeters was converted to the same number of points ranging from 0 to 100 points. There are no subgroups.
Time frame: Pre-procedure (Baseline) and procedure (Time 0)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Benzocaine | Change in Pain Score | 50.6 mm |
| Saline Spray | Change in Pain Score | 70.4 mm |
Comparison: An a priori sample size calculation determined at least 28 patients were needed to detect a clinically significant 13 mm difference in pain score (α=0.05, power =0.80) with a standard deviation of 12 mm. Intention to treat analysis was performed.p-value: 0.43Wilcoxon (Mann-Whitney)
Secondary
Change in Pain Score From Pre-procedure to 5 Minutes Post Procedure.
The patients pain scores will also be assessed at 5 minutes post procedure and the change in pain scores from baseline to this time points will be analyzed. The pain scores will be subtracted to obtain the change in pain score
Time frame: 5 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Benzocaine | Change in Pain Score From Pre-procedure to 5 Minutes Post Procedure. | -11.1 mm |
| Saline Spray | Change in Pain Score From Pre-procedure to 5 Minutes Post Procedure. | -37 mm |
p-value: 0.33Wilcoxon (Mann-Whitney)
Secondary
Patient Satisfaction
The patient's satisfaction will be assessed using a validated satisfaction scale 30 minutes post procedure.
Time frame: 30 minutes post procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Benzocaine | Patient Satisfaction | Extremely satisfied | 10 participants |
| Benzocaine | Patient Satisfaction | Very satisfied | 2 participants |
| Benzocaine | Patient Satisfaction | Satisfied | 2 participants |
| Saline Spray | Patient Satisfaction | Extremely satisfied | 10 participants |
| Saline Spray | Patient Satisfaction | Very satisfied | 4 participants |
| Saline Spray | Patient Satisfaction | Satisfied | 0 participants |
Comparison: Fisher exact test was used to assess differences in satisfaction scores by treatment group. Correlation between pain and satisfaction scores was assessed by Spearman's correlation coefficient.p-value: 0.4Fisher Exact