Abstract
Aim
In Germany, treatment of HSIL or AIS of the uterine cervix by loop excision is performed
almost exclusively under general anaesthesia (GA). International studies and guidelines
show high
acceptance of local anaesthesia (LA) due to hermeneutic, medical, and economic factors.
We performed an observational comparative study aiming to prove advantages of local
anaesthesia within
the German health system.
Patients and Methods
In a prospective observational study, patients diagnosed with HSIL or AIS of the uterine
cervix were treated at the Institute for Cytology and Dysplasia, Berlin, by loop excision
in 2021.
We started with a feasibility study : 303 patients diagnosed with HSIL/AIS of the uterine cervix and her colposcopist
answered an electronic questionnaire with respect
to loop excision under LA.
Since we found a high acceptance for LA in patients and colposcopists, we initiated
a comparative study LA vs. GA: 322 patients underwent loop excision and
selected their mode of anaesthesia: n = 206 LA vs. n = 116 GA. 114 patients of the
feasibility study had to undergo loop excision and became part of the comparative
study (n = 79 for the LA
group, n = 35 for the GA group). All patients received a standardised questionnaire
to document their pain score within 24 h after treatment on a visual analogue scale,
i.e. VAS, between 0 and
100. 178 patients of the LA group and 80 patients of the GA group completed and returned
the questionnaire and form the cohort for our comparison of LA vs. GA. With 191 of
these 258 patients,
i.e. 74%, a telephone survey was performed to ask for patient satisfaction and the
rates of recurrence after a mean interval of 1 year post surgery. We postulate that
there will be no
clinically relevant significant difference in satisfaction and postoperative pain
between patients in the LA group and the GA group.
Results
In the feasibility study , 90% (272 of 303) of patients diagnosed with HSIL or AIS were considered eligible
for LA by their colposcopists. 75% (227 of 303) of
patients were open to loop excision under LA.
In the comparative study , 63 of 206 women of the LA group were interviewed preoperatively: 89% would accept
a pain score above 20 during the procedure, 33% a pain
score above 50 and 11% of max. 20. Postoperatively, the median VAS pain score for
loop excision under local anaesthesia was 13.1 in 178 patients, and pain during injection
of local anaesthesia
was 20.9 (p < 0.001). The VAS pain score 20 minutes post surgery did not differ significantly
between 178 patients after local anaesthesia versus 80 patients after general anaesthesia
(p = 0.09). The surgeons estimated the patient’s pain significantly less than the
patients themselves with an underestimate of −14.63 points on the VAS (p < 0.001).
Within 7 days following loop excision under LA, 95.5% of 178 patients would choose
local anaesthesia as their preferred method for a potential repeat loop excision,
8.8% of which would
like additional painkillers, and 4.5% would choose general anaesthesia.
In a telephone follow-up survey of 133 women from the LA group after a mean of 12
months post surgery, 97% were “satisfied” or “very satisfied” with the treatment carried
out. For patient
satisfaction and postoperative pain, no clinically relevant significant difference
was seen between the LA and the GA group.
The rate of secondary bleeding (6.7% vs. 8.1%, p = 0.72), recurrence of HSIL/AIS (3.6%
vs. 5.2%, p = 0.62), and the distribution of the histopathological R status (R0 89.5%
vs. 81.1%,
p = 0.73; R1 5.3% vs.12.2%, p = 0.57, Rx 4.1% vs. 5.4%, p = 0.65) showed no significant
difference when comparing the LA group versus the GA group.
Conclusion
Following loop excision under local anaesthesia, more than 95% of patients would choose
this method again for repeat surgery. One year post surgery, 97% of the patients were
“satisfied” or
“very satisfied” with the treatment under local anaesthesia. Offering local anaesthesia
for loop excision to patients should be mandatory and included in current guidelines.
Keywords CIN - Loop excision - local anaesthesia
