Download One-Step Topical Anesthetic / Dilating Drop CombinationQA Study

Quality Improvement Analysis
3rd Quarter 2002
One-Step Topical Anesthetic / Dilating Drop Study
1) Identification of an important problem/concern.
The process for preparing each patient for cataract eye surgery is laborintensive and time-consuming. Pre-op dilating eye drops ordered by the
surgeon must be started after the patient has been registered on admission,
their consent form has been explained and they have signed it, and their
admission assessment has been completed. There is often inadequate time
for the dilating drops to be fully effective before the patient needs to be taken
into the O.R. Secondly, patients often complain about the discomfort of
receiving the eye drops.
2) Evaluation of the frequency, severity, and source of the problem / concern.
The patients scheduled for cataract surgery must be admitted at least an hour
before their anticipated surgery time in order to receive the multiples of eye
drops multiple times to ensure adequate dilation of their pupil. The patients
are often anxious and unhappy about the long wait-time between their arrival
and the actual start time of their surgery. The pupil-dilation process is started
by the RN as soon as possible after the patient is admitted. However, when
the surgical procedure is short in duration and the time between cases is very
short, there is often too short a time interval from the time the final set of
dilating drops have been given until the time the patient is to be taken into the
O.R. for surgery. Therefore, the pupil of the operative eye is often
inadequately dilated for the procedure. In addition, the instillation of the drops
often causes a burning discomfort for the patient even when preceded by a
drop of Alcaine (proparacaine.) The repeated process of drop instillation adds
to the pre-operative anxiety and discomfort for many of the patients.
3) Measures Implemented to Resolve the Problem / Concern
A study of a time-saving and cost-saving method was proposed for
administering a pre-mixed combination of dilating, antibiotic, and antiinflammatory eye drops combined with anesthetic jelly and instilling this
mixture into the operative eye of forty (40) cataract surgery patients. This
method was based on the study that was done at the Gossage Eye Institute
in Hillsdale, MI and published in Ophthalmology Times (June 15, 2002.)
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The mixture can easily be made by the RN’s pre-operatively the morning of
surgery according to the following formula:
4mL
2% Lidocaine jelly
4gtts
1% Tropicamide Ophth. Sol. (Mydriacyl)
4gtts
2% Cyclopentolate HCl Ophth. Sol. (Cyclogyl)
4gtts 10% Phenylephrine HCl Ophth. Sol. (Ak-Dilate)
4gtts 0.5% Ketorolac tromethamine Ophth. Sol. (Acular)
4gtts 0.3% Ofloxacin Ophth. Sol. (Ocuflox)
This mixture totals approximately 4mL and provides about 16 doses. Using
strict aseptic technique, the ingredients are thoroughly mixed in a sterile cup
with a sterile needle cap. Approximately 0.25mL is drawn through a largebore blunt needle into a TB syringe for each dose and the syringe is recapped
in an aseptic manner. Pre-made labels with the ingredients, the date, and the
initials of the RN are affixed to each syringe. One TB syringe equals one dose
(of approximately 0.25mL.) which equals one liberal strip placed into the
inferior cul-de-sac of the operative eye. It takes approximately 20 minutes for
it to take effect. The operative eye is taped shut following each application to
allow the mixture to penetrate the ocular tissues and prevent the eye from
drying out. Additional applications can be added every 20 minutes. The
mixture initially may be administered by the RN with a written order from the
surgeon. Subsequent doses are administered per the anesthesiologist on an
“as needed” basis. Pre-printed Physician Orders sheets are provided for each
patient, signed by the physician, and noted by the RN.
For the purpose of doing the study, information was entered onto a preprinted monitoring sheet that was placed in each patient’s pre-op file. (See
accompanying form.) As a means for comparison, a “control” group of twentyfive (25) patients who received the traditional method of drop administration
and anesthetic (either topical or eye block) were also evaluated. Rather than
focusing on the obvious time-saving, cost-saving, and safety value of the onestep topical method, our focus during the study was on the effectiveness of
the mixture to adequately dilate the pupil for surgery and on the patient’s
comfort level during their procedure. Therefore the following information was
obtained and evaluated:
 Amount of pupil dilation 20 minutes after initial application of mixture.
 The need for additional application(s) of mixture for additional pupil
dilation and/or additional anesthetic level.
 The need for additional drops or mechanical means for pupil dilation.
 The need for additional anesthetic medication(s) and/or adjuncts for
pain control.
 Each patient’s rating of comfort vs. discomfort with the use of “0 to 10
Rating Scale” (with “0” as no discomfort and “10” as the worst pain
they can imagine.)
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Study Results:
C = Control Group of 25 patients. (All 25 patients received the traditional 4-drop regimen
every 5 minutes x3.)
S = Study Group of 40 Patients.
Pupil dilation 20 minutes after initial application of mixture:
<4mm 4-4.5mm 5-5.5mm 6-6.5mm 7-7.5mm 8mm
9mm
C: None None
2(15%)
2(15% )
1(7%)
2(15%) 4(30%)
S: None 5(15%) 3(9%)
9(28%)
6(18%) 7(22%) 2(6%)
10mm Not indicated
None 12
1(3%) 8
At least one additional dose of mixture was needed as determined by anesthesiologist:
C: N/A
S: No =20
Yes = 20
(Note: during the first part of the study the anesthesiologist gave a second dose of mixture for
additional anesthetic effect. However, he later found that two doses of plain Lidocaine jelly
after the initial dose of mixture gave a better anesthetic effect.)
Additional dilating eye drops were needed:
C: No = 23
Yes = 2
S: No = 28
Yes = 12 (4 pts needed addit. dil. gtts after 2nd dose of mixture.)
Additional dilation with a surgical instrument was needed.
C: No = 25
Yes = 0
S: No = 40
Yes = 0
Additional anesthetic medication(s) and/or adjuncts were needed during surgery:
C: No = 25
Yes = 0
S: No = 39
Yes = 1 (first pt in study group rec’d addit Lido Jelly plus narcotic &
Versed in the O.R.)
Note: the first pt in the study group to receive the mixture received only the one dose
before surgery & no additional topical anesthetic in pre-op.)
Patient pain scale rating for surgical discomfort (based on 0 – 10):
0-1 (no pain)
2
3
4
>4
C: 25
S: 38
None One
One
None
4.
Re-evaluation Based on Study Data
The study showed that the Lidocaine/drop mixture was well tolerated by
the patients with no complaints of discomfort with application. At least 70%
of the study patients had an adequate pupil dilation result 20 minutes after
the initial dose. The anesthetic result after one dose was not adequate,
however. All patients receiving topical anesthesia (with or without dilating
drops added) need 2-3 doses of the Lidocaine jelly to be comfortable
during their surgery. The study also showed that the admission process
could be shortened by at least 5 minutes per patient with the one
application method.
5.
All results of the study reported to the Total Quality Management
Committee and the Governing Body.
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PHYSICIAN’S ORDERS
Date of Surgery __________________
Patient’s Name _____________________________
Consent For: CATARACT EXTRACTION WITH IOL RIGHT EYE
Date
Time
Orders
Dilate RIGHT eye with 0.25cc of the following mixture.
2% Lidocaine Jelly – 4mL
1% Mydriacyl – 4gtts
2% Cyclogyl – 4gtts
10% Ak-Dilate – 4gtts
0.5% Acular – 4gtts
0.3% Ocuflox – 4gtts
Repeat x1 in 20 minutes per request of anesthesiologist.
IV or Saline Lock per anesthesiologist.
Additional pre-op anesthesia and Honan cuff per
anesthesiologist.
LUMIGAN – one (1) drop, CILOXAN - one (1) drop, and
ECONO-PRED – one (1) drop in RIGHT eye post-op in the
O.R.
DIAMOX 250mg - one (1) tablet by mouth @ time of
discharge.
Discharge when stable with pack provided by office.
John Smith, M.D.
Another brand of a generically equivalent product as approved by the Pharmacy & Therapeutics Committee may be
administered unless the physician states otherwise.
John Smith, M.D.
1234 Sunshine Drive
Happy Valley, CA 12345
(800) 123-4567
9/02 QA Study
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One-Step Topical Anesthetic / Dilating Drop Combination
QA Study Patient Evaluation Form
Date:_____________
Pre-op:
 Patient’s allergies verified.
 Lidocaine / dilating drop mixture administered:
 No – reason:__________________________________________
 Yes – OS / OD
Time:______________
 Medicated eye taped shut
RN signature:_____________________________
Pupil dilation 20 minutes after administration:_____mm. Noted by:____________
Additional dose(s) mixture administered:
Time:_____ Administered by:___________________________________
Time:_____ Administered by:___________________________________
Pupil dilation:___mm @ (time):_____noted by:___________________________
___mm @ (time):_____noted by:___________________________
Additional lidocaine jelly (without added drops) administered by anesthesiologist:
 No  Yes:_______________________________________________
Additional administration of dilating eye drops needed:
 No  Yes – type:__________________________________________
Intra-op:
Pt experienced discomfort in operative eye during prep and/or surgery:
 No  Yes:________________________________________________
Additional anesthetic was needed:
 No  Yes
If yes, type:
 Tetracaine / Alcaine gtts
 Lidocaine injection by surgeon
 IV sedation by anesthesiologist
 Other:______________________________
Additional dilation was needed with surgical instrument:
 No  Yes:________________________________________________
Post-op:
Patient’s rating of discomfort to eye during surgery:
0 1 2 3 4 5 6 7 8 9 10
Least pain ----------------------------------------------------------- Worst pain
Other adverse reaction noted:  No 
Yes:_______________________
Comments:
-----------------------------------------------------Patient Label – Do not write in this space
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