APPENDIX 5 SURGERY Policy Statement

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APPENDIX 5
SURGERY
Policy Statement
I. EINSTEIN Institutional Animal Care and Use Committee (IACUC) policy and Federal regulations require:
A) For non-mouse, non-rat, USDA-regulated species that written records be kept of surgery and intraoperative
monitoring data. These are part of the documentation of adequate veterinary care. These records must be
maintained for the life of the study at minimum and must be readily available for inspection.
B) The written plan for post-operative care (items 12 and 13 above) be followed precisely. For all mammalian
species, written records MUST be kept to document that the post-operative medications and care were given.
These records must be maintained for the life of the study at minimum and must be readily available for
inspection by the Committee and USDA Inspectors.
1) List Surgeon(s) below (If performing survival surgery, individuals listed here MUST have attended IACUC training
session related to performing survival surgeries. If they have not attended the mandatory training sessions, this protocol
will not be approved until such time as said training has been completed):
Surgeon
Work Phone Number
After Hrs Phone #, pager or beeper
1A. Will survival surgery be performed?
No. Go to 2.
Yes. Complete item b.
1B. Have all the surgeons listed above attended the mandatory IACUC training session on survival surgery? (As
noted above, all the surgeons performing survival surgery must complete the training related to this procedure).
No. Please have surgeon(s) register for training. 1
Yes.
2) Description of Surgery. Describe each of the surgical procedures below in detail (in chronological order so that it is
clear what is being done and how it is done). A separate description (Appendix 5) is needed for each type of
procedure. When multiple procedures are performed on an animal, please describe the sequence and timing of these
procedures so that it is clear what is happening to the animals during the study. Provide supplemental pages if needed. *
Detailed descriptions of surgeries involved in the production of transgenic and knockout founder mice are not required if
EINSTEIN Transgenic and Gene Targeting Facility will perform these procedures following their standard protocol.
2A. Procedure (provide detailed description):
Description:
2B. Preoperative procedures:
2B(i) Will animal be fasted prior to surgery?
Yes. If Yes, for how long prior to surgery?
No.
Duration:
1
To register for training, please visit the “MouseHouse” website.
Appendix 5
[1]
2B(ii) Will animals be held off water prior to surgery?
Yes. If Yes, for how long prior to surgery?
No.
Duration:
2C. Paralyzing Agents. These agents do not block pain sensation. Federal regulations prohibit the use of these
agents without general anesthesia.
2C(i) Will paralyzing agent(s) be used?
No.
Yes. Answer items 2C(i)(a) and 2C(i)(b).
2C(i)(a) Why is it necessary to use a paralyzing agent?
Reason:
2C(i)(b) Explain how the depth of anesthesia will be monitored while paralyzing agent is being
administered.
Will be Monitored as follows:
2D. Anesthesia:
2D(i) List who will be responsible for administering anesthesia:
Name
Work Phone Number
After Hrs Phone #, pager or beeper
2D(ii) Will preanesthetic be administered?
No.
Yes. Complete information below.
Drug
Preanesthetic
Dose
Route
2D(iii) Will preemptive analgesic be administered?
No.
Yes. Complete information below.
Drug
Preemptive Analgesic
Dose
2D(iv) Provide information regarding induction of general anesthesia.
Induction
[2]
Route
Drug
Dose
Route
2D(v) Provide information on anesthesia maintenance.
Maintenance
Dose
Drug
Route
2E. Preparation of Animal. Check the procedures that will be performed.
Clip Hair
Scrub site. Provide disinfectant(s) which will be used to
prepare skin for aseptic surgery:
Place I.V. Catheter
Other. Describe below.
Description:
2F. Describe incision in animal, including location.
Description:
Location of Incision:
2G. Describe Operation/Manipulation.
Description:
2H. Intraoperative monitoring of animal’s condition. Indicate the specific methods you will use to monitor the state
of anesthesia and general well being. A complete description will include the name of the monitoring tests, when and how
often they will be used. Note: If a paralyzing agent will be used (see item 2 below), special methods must be used to
monitor adequacy of anesthesia since those that rely on a movement response to stimulus will be useless.
Check
All that
Apply
Method
Frequency
Toe pinch (withdrawal reflex)
Heart rate
Respiratory rate
Corneal touch (blink reflex)
Other (describe):
Must be at least every 10 minutes.
Must be continuously.
Must be continuously.
Provide frequency:
Provide frequency:
2I. Suture for closing incision.
2I(i) What type of suture will be used to close incision?
Suture type:
2I(ii) Size of the suture?
Size:
2J. Will animal survive after surgery?
[3]
No. Complete item i) below.
Yes. Skip item to j) below.
2J(i) How will animal be euthanized?
Method of Euthanasia:
2K. How long will animal survive after surgery?
Animal will survive for:
2L) Will multiple survival surgery be performed?
No. Go to m.
Yes. Complete information below.
21L(i) Description of multiple survival surgeries:
2nd Surgery
Explain procedure:
Interval between each successive surgery:
Scientific justification for performing more than one procedure in a single animal:
Location where this procedure will be performed. Provide building and room location.
3rd Surgery
Explain procedure:
Interval between each successive surgery:
Scientific justification for performing more than one procedure in a single animal:
Location where this procedure will be performed. Provide building and room location.
3) Surgery Location. Where will surgery be performed? (Check ALL that apply)
Check Below
Kennedy B36
Ullmann 1005
Hood with Barrier
Provide Information
Building:
Laboratory Area
Provide Information
Building:
Montefiore Medical Center
Provide Information
Building:
Room #:
Room #
Room #
NOTE: Area within the laboratory must not be used for any other purpose except surgery when procedure is
being performed.
4) Aseptic Surgery. All survival surgery must be performed aseptically.
4A. What method(s) will be used to sterilize surgical instruments, implanted materials and packs prior to surgery?
[4]
Method(s):
4B. Current EINSTEIN policy on surgery allows the re-use of surgical instruments in a single surgery session
(day) for rodent surgery only. However when reusing instruments in a single surgery, you may use the same instrument
on up to 5 animals within three hours. After that you must obtain new surgical instruments. Once it is opened, will the
same instrument pack or any of the surgical instruments be used on more than one rodent during a surgery session?
No
Yes. If Yes, complete table below.
4B(i) What method(s) be used to disinfect or sterilize surgical instruments that will be used between
animals during session?
Hot bead sterilizer
Cold Sterilizer (i.e.
Other (describe):
Dipped in 70% alcohol for 15 minutes followed by
rinsing in sterile saline/irrigating solution
4C. The following additional aseptic techniques must be used.
**
For Rodents (Rat & Mice)
REQUIRED:
 Sterile Gloves**
 Clean Gown/Laboratory Coat
 Sanitize Hand
 Face Mask
 Drapes
Clean Non-Sterile Gloves may only be used if
exposed tissue will not be touched (i.e. micro surgical
procedure)
For USDA Covered Species
REQUIRED:
 Sterile Gloves
 Full Surgeon Scrubs
 Mask
 Cap
 Surgical Drape
5) Post-Operative Monitoring. This will require that animals be identified using pink post-operative monitoring cards
available through the Institute for Animal Studies outside Ullmann 1003.
5A. Describe physical support methods (i.e. a source of heat to help maintain body temperature.
Description:
5B. Post-operative drugs: analgesics, antibiotics, fluids (also see item 4 below):
Name Drug / Fluid
Dose
Dose Schedule (You must include route, frequency,
duration or maximum number of doses)
6) Post-operative analgesia. Post-operative care MUST include assessment of the animal for pain and discomfort
including specific criteria for determining if the animal is uncomfortable or painful. Post-operative drug therapy should
include routine administration of an analgesic or a contingency plan with specific criteria for your decision to give or
withhold analgesia. It is generally considered preferable to err on the side of providing an analgesic that may not be
needed than to withhold one. For all procedures that constitute more than a minor surgery, analgesics should be
administered. Current veterinary standards indicate that pre-emptive analgesic use provides superior analgesic effect.
Therefore, the appropriate dose of analgesic should be administered prior to making the incision (ideally during the
anesthesia induction stage).
[5]
Preemptive analgesics are preferred for pain management and are generally effective with a single pre-operative dose.
Post operative care must include assessment of pain and discomfort. Must include assessment of pain in conjunction
with veterinary staff to determine use of additional analgesic.
6A. Will analgesic be administered in the operative period (pre-emptive or gas anesthetic)?
Yes, routinely an initial dose is given then subsequent treatments are based upon assessment of the animal’s
condition.
Describe below specific behaviors or symptoms, which will be used as criteria to identify a painful animal who will
be given the analgesic as indicated above. The description must include the monitoring schedule.
Description:
MEDICAL RECORD MUST INCLUDE NOTATIONS AS TO ANIMALS CONDITION TO SUPPORT DECISION TO
CONTINUE OR DISCONTINUE A TREATMENT
No, analgesics will not be given because the surgical procedure is minor, and animals return to normal activity,
eating and drinking within a few hours of this surgical procedure. Animals are checked twice per day following
surgery for two days. If, however, animals have not returned to normal activities within the first 12 hours, they will
be provided analgesic or euthanized.
No, analgesics cannot be given because the use of any analgesic will interfere with the objectives of this
experiment. The use of an analgesic is contraindicated because:
Provide reason:
Please scientifically justify how analgesics will interfere with experimental objectives. Below. Please provide
published references to support your claim if possible. This should also be included in search for alternatives in
item 21 of main form.
Scientific Justification:
6B. What criteria will be used to determine whether a post-operative animal should be euthanatized rather than
treated?
Criteria:
6C. Who will be responsible for postoperative care?
Name
Work Phone Number
After Hrs Phone #, pager or beeper
NOTE: To assist you in monitoring post-operative animals, all animals (including rodents) should have a post-surgical
card placed on their cage. Post-operative treatments and observations may be recorded on this card.
7) Suture Removal. Skin incisions generally heal within 10-14 days. Skin sutures or wound clips should not be left in
place beyond 2 weeks following surgery as they act as a foreign body, becoming a source of irritation and infection.
7A. Will skin sutures or wound clips be removed within 10 post surgery?
No. Answer 7B(i) AND 7B(ii) below.
Yes. Got to 8..
7B. Removal of skin sutures later than 10 days.
[6]
7B(i) When will sutures be removed?
Skin sutures will be removed:
(ii) Why must sutures be removed later than recommended?
Reason:
[7]
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