peer to peer thermal balloon endometrial ablation in office

PEER TO PEER THERMAL BALLOON
ENDOMETRIAL ABLATION IN OFFICE
PAIN MANAGEMENT PROTOCOL
RECOMMENDATIONS
1
PATIENT COMFORT
In-office options, protocols and techniques for providing patient comfort.
Prior to initiating office procedures we recommend that the surgeon contact the regulating
agency in their specific state to become familiar with any guidelines, regulations or statutes
that may exist regarding office-based procedures, levels of anesthesia, patient monitoring,
training and certification requirements. Failure to follow state guidelines could potentially
result in criminal prosecution if any adverse events were to occur.
OVERVIEW
Individual gynecologists should choose a pain management plan that addresses each patient’s
needs and suits their experience and circumstances when developing their own protocol for
in-office ablation. However, all treatment plans should include these three equally important
elements:
1. Pre-procedure medication
At Home:
NSAIDS (24 – 48 hours)
Tell the patient to eat a light meal prior to the procedure
Upon arrival to the office:
NSAIDs, Anxiolytic, Antiemetic, Narcotic
Wait 35 - 45 minutes for peak onset
2. Intra-procedural local anesthesia
Paracervical block
• Use a control syringe
• Allow 5 - 10 minutes for optimal anesthetic onset
Talk to the patient in soothing tones (“vocal local”)
Play music that is preferably chosen by patient
3. Post-procedure pain management
Consider NSAIDs, Narcotic, Antiemetic
Advise patient to take it easy for the rest of the day
Recommend analgesics on a scheduled (not prn) basis for first 24 hours
Call your patient after her procedure to see how she is doing
The anesthetic block procedure described in this educational module is not
intended to be used as a procedural training guide. The recommendations
given are the opinions of the authors and do not constitute training or
endorsement by Ethicon, Inc. Other surgeons may employ different techniques.
2
MEDICATIONS COMMONLY EMPLOYED IN OFFICE BASED PROCEDURES
Other acceptable options may exist and this list is not meant to be conclusive of all possible
medications. See drug prescribing information for detailed list of contraindications, warnings
and precautions.
NSAID
Ketorolac (Toradol®), Ibuprofen (Motrin®), Celecoxib (Celebrex®),
Naproxen (Aleve®)
Anxiolytic
Alprazalam (Xanax®), Diazapam (Valium®), Lorazepam (Ativan®)
Antiemetic
Ondanestron (Zofran®), Promethazine (Phenergan®)
Narcotic
Oxycodone (Percocet®), Hydrocodone/acetaminophen (Vicodin®,
Lorcet®, Anexia®), Propoxyphene (Darvon®), Belladonna & Opium (B&O)
Suppository,Meperidine (Demerol®)
Antispasmodic
Dicyclomine (Bentyl®), Belladonna & Opium (B&O) Suppository
POTENTIAL LOCAL ANESTHETIC AGENTS
Local anesethetics differ in terms of onset, duration and toxicity. The following chart is
intended as a guide only.
Severe reactions can occur with injection into arteries and veins. To avoid, one should aspirate
prior to injection and any time the needle is advanced (*Marcaine not recommended)
Agent
O n s et
Duration
St re n g t h
M a xi m u m
Dosage
Xylocaine (Lidocaine®)
• Short duration, Low cardiac toxicity
<2 min
(quick onset)
0.5 – 1
hour (short
duration)
0.5% to 2%
most common
1%
300mg
or 5mg/kg
Xylocaine (Lidocaine®) w/
Epinephrine
• Decreases local blood flow
• Delays systemic absorption
(prolongs anesthesia)
• Reduces the risk of toxicity with
a favorable balance between
anesthesia & blood flow
• Using alone can result in systemic
toxicity (increased heart rate, heart
palpitations, HTN, NA, nervousness)
<2 min
(quick onset)
2-6 hours
1:50,000,
1:100,000,
1:200,000
300mg
or 7mg/kg
Mepivacaine (Carbocaine®
Polocaine ®)
• Longer acting, Low cardiac toxicity
3-20 min
2-2.5 hours
1% (4mg/kg)
400mg
Ropivacaine (Naropin®)
Long acting, Low cardiac toxicity
1 – 15
2-6 hours
0.5% (2.5mg/
kg)
300mg
Covino BG. Pharmacology of Local Anesthetic Agents. J Dent Res. 1981. Aug 60(8):1454-9
The third party trademarks used herein are trademarks of their respective owners.
3
PARACERVICAL BLOCK GUIDELINES
Chapa HO. Utility of in-office endometrial ablation: A prospective cohort study of
endometrial ablation under local anesthesia. J Repro Med. 2008;53: 827-831.
Illustration of injection at 4 o’clock just medial to cervico-vaginal reflection
• Inject 5 – 10cc* at 2, 4, 8, 10 o’clock just medial to cervico-vaginal reflection
• Avoid 3 and 9 o’clock due to proximity of uterine vessels
• Always aspirate prior to injection
• Inject 1 – 1.5 inches deep
*The anesthetic block procedure described in this educational module is not intended to be used as
a procedural training guide. The recommendations giv en are the opinions of the authors and do not
constitute training or endorsement by Ethicon Inc. Other surgeons may employ different techniques
The third party trademarks used herein are trademarks of their respective owners.
4
GYNECARE THERMACHOICE® III PAIN MANAGEMENT PROTOCOLS*
Samantha Patwardhan MD, Partners in Women’s Health, Denver CO
Medication
Dosage
Time Course
Pre-procedure
Ibuprofen
Valium
Vicodin®
Toradol®
Atropine
800mg PO tid
5mg PO
5/500mg
30mg IM
0.4mg IM
Starting 48 before procedure
Two hours before procedure time, at home with food
Upon arrival to office 45 minutes prior to procedure*
30 min pre-procedure
30 min pre-procedure (combine with Toradol® for single IM shot)
*For patients with known history of vasovagal episodes,
substitute Demerol® 50mg in place of Vicodin®.
Intra-procedure
Block Solution: Carbocaine® 1% 30cc Block: With 10cc syringe and spinal needle, inject into ectocervical
stroma at 12 o’clock for tenaculum placement. Inject 5cc each at 10/ 2 o’clock, then 10cc each at 8/4 o’clock.
The posterior points are typically more uncomfortable, so best to do second. Inject at the junction of the
cervix and the vagina, in the fornices. Depth of needle is 5mm at most
Post-procedure
Phenergan®
Vicodin®
25mg rectal
suppository
5/500mg
Ibuprofen
800mg tid
Immediately following removal of speculum
Upon arrival home, take Vicodin® and apply heating pad,
regardless of pain score.
To start 8 hours after last preop dose for 24 hours, prn after that
Hector Chapa MD, Women’s Specialty Center, Dallas TX
Medication
Pre-procedure
Celebrex® (or equivalent)
Xanax®
Zofran®
Toradol®
Bentyl®
Dosage
Time Course
400mg 1PO bid
1mg sublingual
8mg ODT x 1
30mg (1ml)
sublingual
40mg po x 1
Night prior and morning of procedure
30 min pre-procedure
30 min pre-procedure
30 min pre-procedure
30 minutes pre-procedure
Intra-procedure
Block Solution: 1% Carbocaine® 30ml mixed with 20 ml saline and 30mg (1ml) Toradol® (51ml total solution).
Block: Inject 2cc superficially at 11:30 and 12:30 positions (tenaculum sites). Total of 40ml injected via 22G x 1.5
inch needle at 4/8/2/10 o’clock (10cc per location). Inject at cervico-vaginal reflection.
Post-procedure
NSAID
May administer addl NSAID dose at least 3-4 hours post
initial dose
*The anesthetic block procedure described in this educational module is not intended to be used as
a procedural training guide. The recommendations given are the opinions of the authors and do not
constitute training or endorsement by Ethicon Inc. Other surgeons may employ different techniques.
The third party trademarks used herein are trademarks of their respective owners.
5
GYNECARE THERMACHOICE® III PAIN MANAGEMENT PROTOCOLS* — CONTINUED
Lowell McCauley MD, Knoxville TN
M e d i c a t io n
D os a g e
T i m e Co u r s e
Pre-procedure
Motrin®
Toradol®
Xanax®
Percocet®
800mg PO Q 6-8
60mg IM
2mg PO
24-48 hours pre-procedure
45-60 min pre-procedure
45-60 min pre-procedure
45-60 min pre-procedure
Zofran®
B&O
Body weight less than 150 lbs = two (2)
Percocet® 5.0/325 tabs. Body weight 150
- 200 lbs = 1.5 of the 7.5/325 tabs. Body
weight greater than 200 lbs = two (2)
Percocet® 7.5/325 tabs
4mg PO
16/60 Rectal Suppository
45-60 min pre-procedure
45-60 min pre-procedure
Intra-procedure
Block Solution: 0.5% Ropivacaine 30cc mixed with 1% Xylocaine 10cc and 30cc normal saline (70cc total
solution). Block: Inject 3-4cc superficially at 12 o’clock position (tenaculum site) Inject 10cc at the 4,8,2,10
o’clock positions via 20cc control syringe and 22G 1.5 inch. Inject at cervico-vaginal reflection. Avoid 3 o’clock
and 9 o’clock due to proximity of uterine vessels.
Post-procedure
Oxycodone
Ibuprofen
Zofran®, Reglan®, or
Phenergan®
1-2 tablets every four hours for 8-24
hours
1 every six hours for next 12-24 hours
As needed for nausea
Amy Brenner MD, Cincinnati OH
M e d i c a t io n
D os a g e
T i m e Co u r s e
Pre-procedure
Motrin®
Toradol®
Xanax®
Percocet®
Bentyl®
800mg PO Q 6-8
30mg sublingual
1-2 mg PO based on weight of 150 lbs
5.0/325 or 7/325 2 PO
40mg PO
24 hours prior to procedure
45-60 min pre-procedure
45-60 min pre-procedure
45-60 min pre-procedure
45-60 min pre-procedure
Intra-procedure
Block Solution: Carbocaine® 1.5% 15cc mixed with Saline 30cc, Toradol 30mg (1cc) Block: Inject 3-4cc
superficially at 12 o’clock position (tenaculum site) Inject 10cc at the 4,8,2,10 o’clock positions via 20cc control
syringe and 22G 1.5 inch. Inject at cervico-vaginal reflection.
Post-procedure
Percocet®
Bentyl®
40mg PO
4 hours post-procedure
4 hours post-procedure
*The anesthetic block procedure described in this educational module is not intended to be used as
a procedural training guide. The recommendations given are the opinions of the authors and do not
constitute training or endorsement by Ethicon Inc. Other surgeons may employ different techniques.
The third party trademarks used herein are trademarks of their respective owners.
6
GYNECARE THERMACHOICE® III PAIN MANAGEMENT PROTOCOLS* — CONTINUED
Michael Woods MD, Bellevue Ob/Gyn, Bellevue NE
M e d i c a t io n
D os a g e
T i m e Co u r s e
Pre-procedure
Motrin®
8 0 0 mg
Star ting 24 hours pre -procedure. At
least three doses ie: am, lunch, dinner,
HS, am of procedure day and 1 hour
pre-procedure
Intra-procedure
Block solution: 0.5% Lidocaine® with 1:200,000 epinephrine 20cc buffered with 2ml 0.85% sodium
bicarbonate (prevents stinging associated with infiltration). 22g 1 inch needle on a 6 inch needle extender.
Bury to the hub and inject at either 10,2,4,8 or 12,3,6,9 o’clock. Wait 90 seconds to perform hysteroscopy.
Test the block by touching the hysteroscope to the fundus near each tubal ostia and the midline to check for
cramping. Use a Novak or small sharp curette to check the block at 2,4,8,10 o’clock. If no pain, proceed with
ablation. If pain, infiltrate another 10 ml buffered Lidocaine® use a 22g 1.5 inch needle at region pain was felt.
Wait 60 seconds and recheck. Proceed with ablation once pain is no longer felt.
Post-procedure
Motrin®
Hydrocodone/
Acetaminaphen
Phenergan®
Suppository
800mg
10/325 or 10/500 X2 PO
25-50mg (depending on patient size)
At 4 hours post-procedure and q8 hours
24 hours post-procedure
If any cramping at all, patient instructed
to take Hydrocodone/Acetaminaphen
and place Phenergan® suppository
vaginally. If still cramping 45 minutes
later, repeat dose for both medications.
Very important that patient takes pain
medication at start of cramping, not
when pain is worse.
*The anesthetic block procedure described in this educational module is not intended to be used as
a procedural training guide. The recommendations given are the opinions of the authors and do not
constitute training or endorsement by Ethicon Inc. Other surgeons may employ different techniques.
The third party trademarks used herein are trademarks of their respective owners.
7
®
®
GYNECARE
THERMACHOICE
III PROCEDURE
GYNECARE
THERMACHOICE
III
UTERINE BALLOON THERAPY SYSTEM
ESSENTIAL PRODUCT INFORMATION – PHYSICIAN
INDICATIONS: The GYNECARE THERMACHOICE® III System is a thermal balloon ablation
device intended to ablate the endometrial lining of the uterus in premenopausal women with
menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is
complete.
CONTRAINDICATIONS: The device is contraindicated for use in a patient who is pregnant
or who wants to become pregnant in the future (pregnancies following ablation can be
dangerous for both mother and fetus); with known or suspected endometrial carcinoma
(uterine cancer) or premalignant change of the endometrium, such as unresolved adenomatous
hyperplasia; with any anatomic condition (eg, history of previous classical cesarean sections or
transmural myomectomy) or pathologic condition (eg, chronic immunosuppressive therapy)
that could lead to weakening of the myometrium; with active genital or urinary tract infection
at the time of procedure (eg, cervicitis, vaginitis, endometritis, salpingitis, or cystitis) or with
active pelvic inflammatory disease (PID); with an intrauterine device (IUD) currently in place.
ADVERSE EVENTS: include cramping/pelvic pain; nausea and vomiting; complications with
pregnancy (Note: pregnancies following ablation can be dangerous for both mother and
fetus); endometritis and risks associated with hysteroscopy; post-procedure symptoms such as
pain, fever, nausea, vomiting and difficulty with defecation or micturition; hematometra; rupture
of the uterus; thermal injury to adjacent tissue; heated liquid escaping into the vascular spaces
and/or cervix, vagina, fallopian tubes, and abdominal cavity; electrical burn; hemorrhage;
infection or sepsis; perforation; post-ablation tubal sterilization syndrome; complications leading
to serious injury or death; vesico-uterine fistula formation.
WARNINGS: Failure to follow all instructions or to heed any warnings or precautions could
result in serious patient injury. The device is intended for use only in women who do not desire
to bear children because the likelihood of pregnancy is significantly decreased following this
procedure. Pregnancies following ablation can be dangerous for both mother and fetus. If
uterine perforation is present, and the procedure is not terminated, thermal injury to adjacent
tissue may occur if the heater is activated. Endometrial ablation is not a sterilization procedure.
Patients who have previously undergone tubal ligation are at increased risk of developing post
ablation tubal sterilization syndrome which can require hysterectomy. Endometrial ablation
procedures using the GYNECARE THERMACHOICE® III System should be performed only by
medical professionals who have experience in performing procedures within the uterine cavity,
such as IUD insertion or dilation and curettage (D&C), and who have adequate training and
familiarity with GYNECARE THERMACHOICE® III System. Endometrial ablation procedures do
not eliminate the potential for endometrial hyperplasia or adenocarcinoma of the endometrium
and may mask the physician’s ability to detect or make a diagnosis of such pathology. DO
NOT perform same-day GYNECARE THERMACHOICE® III procedure and hysteroscopic tubal
occlusion/sterilization. Ablation may cause intrauterine synechiae, which can compromise (ie,
prevent) the 3-month confirmation test (HSG) for the tubal occlusion device. Women who
8
have inadequate 3-month confirmation tests cannot rely on the tubal occlusion device for
contraception. Bench and clinical studies have been conducted which demonstrate that the
GYNECARE THERMACHOICE® III procedure can be safely and effectively performed with nickel
titanium tubal inserts in place. However, the GYNECARE THERMACHOICE® III procedure should
only be performed after the 3-month tubal occlusion confirmation test.
PRECAUTIONS: Never use other components with the GYNECARE THERMACHOICE® III
System. For the complete list of Precautions associated with the use of this device, consult the
GYNECARE THERMACHOICE® III System instructions for use. Rx Only.
TC3-056-12 Ethicon, Inc. © 2012
9