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ABSTRACT Study Objective: To evaluate the effectiveness of a multimodality local anesthetic protocol for office diagnostic and operative
hysteroscopy.
Design: Retrospective cohort study (Canadian Task Force classification II-3).
Setting: Academic communitybased institution.
Patients: Five hundred sixty-nine women undergoing 639 office-based diagnostic or operative hysteroscopic procedures.
Interventions: Multimodality local anesthetic protocol addressing vagina, cervix, paracervical region, and endometrial cavity.
Measurements and Main Results: Primary outcomes were numeric pain scores and rate of premature termination because of
pain. Secondary outcomes included procedure pain and parity, delivery route, menopausal status, procedure type, and cost
effect on procedure delivery. The overall mean (SD) pain score across 535 evaluable procedures was 3.7 (2.5). Patients
undergoing operative hysteroscopy had a higher mean maximum pain score than did those who underwent diagnostic hysteroscopy only (4.1 vs 3.2; p , .001). There was no difference among women in different age groups; however, those with both
cesarean section and vaginal delivery had scores higher than the mean (4.7 [0.4]; p , .001). The estimated cost savings was
almost $2 million.
Conclusion: Using a multimodality approach to local anesthesia, a broad spectrum of diagnostic and operative procedures can
be performed successfully, comfortably, and inexpensively in the context of an office procedure room, without the need for
procedural sedation. Journal of Minimally Invasive Gynecology (2014) 21, 791798 2014 AAGL. All rights reserved.
Keywords:
DISCUSS
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http://www.AAGL.org/jmig-21-4-JMIG-D-14-00046
792
793
about the maximum pain during both anesthetic administration and the hysteroscopic procedure. The patient was asked
to report the most severe pain experienced, rather than a
perceived mean, even if the most severe pain lasted only seconds. The surgeon recorded all pain scores in the database.
All statistical analyses were performed using SAS 4.3
software (SAS Institute, Inc, Cary, NC). Wilcoxon signedrank tests were used to compare mean pain scores during
anesthetic administration vs during the procedure. Nonparametric tests were used because anesthesia and procedure
pain scores from a procedure for the same patient were
treated as paired data, and the underlying distributions of
the paired score differences were unknown, in particular
for procedures with a small sample size. For patients who
underwent multiple procedures on different days, we
assumed independence between their paired score differences to simplify analyses. Pain scores for diagnostic, operative, and all procedures were collectively analyzed using
linear mixed-effects regression models to account for
within-subject correlation between pain scores per patient.
Pain scores were analyzed in terms of anesthesia-related
pain, procedure-related pain, and overall pain. An overall
pain score of a procedure refers to the maximum value of
the anesthesia and procedure scores. In addition, linear
mixed-effects modeling was performed to determine the
effects of age, menopausal status, previous delivery method,
and category of surgeon performing the procedure on pain
scores during hysteroscopic procedures. We first compared
diagnostic and operative procedures with respect to anesthesia pain scores. On finding no significant difference in
anesthesia pain scores between the diagnostic and operative
procedures, we considered that all procedures had the same
baseline anesthesia pain score. The procedure pain scores
were then adjusted for age and obstetric delivery history.
All statistical tests were 2-sided, with significance set at .05.
Resource use was estimated for diagnostic hysteroscopic
procedures via review of 3 randomly selected institutional
cases, with determination of mean line item costs (not
charges) by the SCPMG Clinical Analysis group in 2006,
the first year of the study. The office procedure room costs
were determined by a system-wide analysis of line item
costs of a large sample of procedures in multiple SCPMG
centers, including our own. These means were calculated
and placed on a spreadsheet (Excel; Microsoft Corp.,
Redmond, WA) for analysis.
Results
A total of 569 consecutive women underwent either diagnostic hysteroscopy or hysteroscopically directed surgical
procedures at UPIC during the study. Because some patients
underwent multiple procedures, 639 procedures were
eligible for the study.
Of these women, 478 were available for analysis of their
surgical pain experience; 91 were excluded owing to missing
pain data. The 478 patients underwent 535 procedures, with
794
pain scores available for each. The missing data were due to a
number of surgeons not being compliant with recording pain
scores. For an additional 12 patients, parity data were missing.
None of the patients with missing data had failed uterine
access or other complications. A total of 639 procedures
were performed: 412 by 1 primary surgeon (M.M.); 136 by
the primary surgeon along with a resident, who administered
anesthesia; and 91 by another surgeon alone. The baseline
characteristics of the study population are given in Table 1.
Of the 639 procedures, 5 were prematurely terminated
because of procedure-related pain, and 3 because of failed
endometrial cavity access. One patient in whom premature
termination was required because of pain returned for a second time after nonsteroidal anti-inflammatory drug prophylaxis and underwent a successful endometrial polypectomy.
Table 1
Patient demographic dataa
Procedure type
Variable
Age, yr
Mean (SD)
Median
Q1, Q3
Range
Age group
1829
3039
4049
5059
R60
Postmenopausal status
No
Yes
Previous obstetric
delivery
Cesarean section
Vaginal
Both
Nulliparous
Indication for
hysteroscopy
Abnormal bleeding
Contraception
management
Infertility
M
ullerian anomaly
Postmenopausal
bleeding
Recurrent pregnancy
loss
Cervical stenosis
Other/Unknown
a
Diagnostic
(n 5 212)
Operative
(n 5 427)
Total
(n 5 639)
41.5 (10.16)
40
35.0, 45.0
(18.082.0)
42.1 (10.97)
39
35.0, 46.0
(20.086.0)
41.9 (10.71)
39
35.0, 46.0
(18.086.0)
14 (6.6)
91 (42.9)
75 (35.4)
16 (7.5)
16 (7.5)
28 (6.6)
189 (44.3)
128 (30)
41 (9.6)
41 (9.6)
42 (6.6)
280 (43.8)
203 (31.8)
57 (8.9)
57 (8.9)
187 (88.2)
25 (11.8)
355 (83.1)
72 (16.9)
542 (84.8)
97 (15.2)
26 (12.3)
62 (29.2)
11 (5.2)
105 (18.9)
43 (10.1)
173 (40.5)
30 (7)
177 (13.3)
69 (10.8)
235 (36.8)
41 (6.4)
282 (15.2)
109 (51.4)
2 (0.9)
115 (26.9)
112 (26.2)
224 (35.1)
114 (17.8)
70 (33)
2 (0.9)
22 (10.4)
110 (25.8)
9 (2.1)
64 (15)
180 (28.2)
11 (1.7)
86 (13.5)
1 (0.5)
5 (1.2)
6 (0.9)
3 (1.4)
3 (1.4)
0
12 (2.8)
3 (0.5)
15 (2.3)
Table 2
Procedure
Adhesiolysis
Catheter placement
Cervical stenosis
Diagnosis
Endometrial ablation
Endometrial biopsy catheter
Endometrial biopsy forceps
Metroplasty
Myomectomy
Polyp, cervix
Polyp, endometrium
Sterilization
21
5
7
189
6
6
11
7
31
4
156
77
4.5
2.2
3.3
3.2
5.3
6.0
3.9
4.7
4.8
3.5
3.8
4.4
2.9
1.8
2.7
2.4
3.6
3.0
2.7
3.1
2.6
1.3
2.1
2.6
4.0
1.0
2.0
3.0
5.0
6.5
5.0
4.0
5.0
3.5
3.0
4.0
2, 6
1, 3
1, 6
1, 5
2, 9
3, 9
1, 7
2, 7
3, 6
2.5, 4.5
2, 5
2, 7
795
.8
ND
1.0
.01
.25
.19
.50
.36
1.0
.01
.25
.52
.02
1.6
ND
1.1
0.7
1.9
0.8
1.7
0.9
1.0
0.7
1.1
0.3
0.4
Age group, yr
1829
3039
4049
5059
R60
Postmenopausal status
No
Yes
Obstetric delivery history
Cesarean section
Vaginal
Both
Abortiona
Never pregnant
2.5, 5
1, 1
1, 2
1, 4
2, 9
1, 2
1, 4
1, 2.5
2, 6
1, 2
2.5, 4.5
2, 4
2, 3
4
1
2
2
3
2
2
1
2
2
4
3
3
2.8
0.0
0.8
2.1
3.8
1.2
1.5
2.2
3.2
2.0
1.3
1.8
1.9
4.3
1.0
1.7
2.7
4.7
1.9
2.3
2.0
3.9
2.0
3.5
2.8
2.8
8
3
6
93
3
9
3
12
7
24
4
90
63
Adhesiolysis
Catheter placement
Cervical stenosis
Diagnosis
Foley catheter
Foley forceps
Endometrial ablation
IUD insertion/removal
Metroplasty
Myomectomy
Polyp, cervix
Polyp, endometrium
Sterilization
Only procedures after 2009 for which there were separate anesthesia and procedure pain scores. Scores are based on a numeric scale of 0 to 10.
a
Wilcoxon signed rank test.
0.0
0.0
0.7
20.6
23.3
1.2
3.0
20.8
0.0
2.4
22.0
20.2
0.9
4
1
2
1
1
2
5
0
4
5
2
2
3
4.3
1.0
2.3
2.1
1.3
3.1
5.3
1.2
3.9
4.4
1.5
2.6
3.6
3.8
0.0
2.9
2.4
0.6
3.1
4.5
1.7
2.7
2.9
1.3
2.5
3.0
1, 7.5
1, 1
1, 2
0, 3
1, 2
0, 6
1, 10
0, 2
1, 6
2.5, 6
0.5, 2.5
0, 5
1, 7
p Value
Median
Median
Procedures (n 5 325)
Anesthesia score
SD
Q1, Q3
Procedure score
SD
Mean differencea
Variable
Q1, Q3
SE
Table 4
Procedure
Table 3
Mean
SE
95% CI
3.8
3.7
3.8
3.7
3.8
0.4
0.2
0.2
0.4
0.4
3.04.6
3.44.1
3.44.1
3.04.4
3.14.5
3.7
3.9
0.1
0.3
3.54.0
3.44.5
3.6
3.9
4.7
3.7
3.5
0.3
0.2
0.4
0.3
0.2
3.04.2
3.54.3
3.95.5
3.14.2
3.13.9
796
Table 5
Total cost comparison: institution operating room vs office procedure room
Office procedure rooma
Preop visit
Preop roomc
Preop laboratory testsc,d
OR/procedure room suppliese
Lidocaine gel 2%
OR time
OR/procedure room staffing
Surgeonf
Anesthesiologist
CRNA
Recovery room
Total
Timed items
Item cost
Cost/Min
Minutes
Cost
Item cost
Cost/Min
Minutes
Cost
$254.85
$224.68
$37.19
$101.81
$44.15
NA
In OR time
Not calculated
NA
NA
NA
NA
NA
NA
NA
NA
$28.97
NA
$0.00
$8.02
$7.73
$6.08
NA
NA
NA
NA
NA
53
NA
Not calculated
30
60
60
$254.85
$224.68
$37.19
$101.81
$44.15
$1535.41
$0.00
$0.00
$240.60
$463.80
$364.80
$3627.29
0.00
0.00
0.00
36.00
44.15
NA
$136.00
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
$0.00
$0.00
$0.00
$36.00
$44.15
$0.00
$136.00
NA
NA
NA
Total
NA
NA
NA
NA
NA
NA
$0.00
$0.00
$0.00
$216.15
CRNA 5 Certified Registered Nurse Anesthetist; NA 5 not applicable, included in OR; OR 5 operating room; Preop 5 preoperative.
a
Diagnostic hysteroscopy only.
b
At Kaiser Permanente Los Angles Medical Center a preop visit is mandatory before operating roombased procedures.
c
No preop visit, room, or laboratory tests are required for office-based procedures.
d
Type and screen, complete blood cell count.
e
Drapes, anesthesia, supplies.
f
Surgeon calculation not included because it was believed to be equal regardless of site.
patients. However, in their study, the primary procedure performed was polypectomy, and the procedure was limited on
the basis of the size of the polyps. In 2007, Bettocchi et al
[24] conducted a study of 260 patients undergoing metroplasty with or without local anesthesia in the office using a
vaginoscopic approach. Overall, the authors were able to
complete the metroplasty successfully in 93.1% of patients,
and no patients experienced any particular discomfort, pain,
or excessive bleeding. However, this was not a randomized
trial, and there was no comparison of pain scores between
patients who received anesthesia vs those who did not.
Moreover, the present study included a larger spectrum of
invasive procedures such as myomectomy and transcervical
sterilization.
In the present study, we were able to effectively demonstrate that the pain associated with application of anesthesia
was not rated any higher than the pain associated with the
procedure itself for operative hysteroscopy (anesthesia/procedure, 2.7 vs 3.1) but not for diagnostic hysteroscopy (anesthesia/procedure, 2.7 vs 2.1). Although vaginoscopy is a
reasonable and practical option for diagnostic hysteroscopy,
it is not always practical in nulliparous women, when larger
diameter instrumentation is required, or when anatomic issues such as cervical stenosis make access to the endometrial
cavity difficult.
Another comparison to highlight involves the metaanalysis by Cooper et al [22] that showed paracervical injection of local anesthetic to be the most effective anesthesia
technique when compared with intracervical, transcervical,
and topical types of anesthesia used during diagnostic office
797
798
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