Supplemental Form 6

SUPPLEMENTAL FORM 6

Surgery

The University at Albany – IACUC

11.08.16

FORM 6 contains following: please read carefully the following descriptions about animal surgery and then complete all applicable sections(s).

Page 1-2 - Instruction and definitions of rodent surgery

Page 3 -5- Surgical Information; provide all applicable information.

NOTE 1: please also read instructions about pain and distress on FORM 3(Pain & Distress) page 1.

** If your laboratory has written Standard Operation Procedures (SOPs) of surgery, please SOP #. The IACUC strongly recommends that each laboratory have IACUC approved SOPs for all of experimental procedures. **

Surgery Guidelines: regulation and definitions

Regulations and Guidelines of Animal Surgery

Ø  The Animal Welfare Act (AWA) [9 CFR (code of Federal Regulations), Part 2, 2.31 (d)[1](ix)] states: "All survival surgery will be performed using surgical gloves, masks, sterile instruments and aseptic techniques.... Non-major surgery and all surgery on rodents do not require a dedicated facility, but must be performed using aseptic technique," and defines a major operative procedure (9 CFR, Part 1, 1.1) as "any surgical intervention that penetrates and exposes a body cavity or any procedure that produces permanent impairment of physical or physiological functions."

Ø  The Guide for the Care and Use of Laboratory Animals (National Research Council) can be read or purchased online at http://www.nap.edu/bookstore/isbn/0309053773.html. The Guide states: “The relative susceptibility of rodents to surgical infection has been debated; available data suggest that subclinical infections can cause adverse physiologic and behavioral responses (Bradfield et al 1992; Cunliffe-Beamer 1990) that can affect both surgical success and research results.

Ø  Post-operative infections in rodents can and do occur. Such infections, which may not be apparent on casual observation, cause distress to and can endanger the animal, as well as endanger the results of the study.

Ø  Both the AWA and the NIH Guide for the Care and Use of Laboratory Animals contain standards for surgical procedures and surgical facilities. The Guide states that "survival surgery on rodents does not require a special facility, but should be performed using sterile instruments, surgical gloves, and aseptic procedures.

National Institutes of Health (NIH) Classifications and Surgery

Ø  MAJOR SURGERY: Any surgical intervention that penetrates and exposes a body cavity; any procedure that has the potential for producing permanent physical or physiological impairment; and/or any procedure associated with orthopedics or extensive tissue dissection or transaction.

Ø  MINOR SURGERY: Any surgical intervention that neither penetrates and exposes a body cavity nor produces permanent impairment of physical or physiologic function. Examples are superficial vascular cut down, and percutaneous biopsy.

Ø  NON-SURVIVAL SURGERY: ANY surgical intervention in which the animal will not recover from anesthesia. This does not include euthanasia followed by procedures conducted postmortem; however, any procedure where an incision is created following the administration of a lethal dose of anesthesia but prior to actual death of the animal is considered a non-survival surgery. Examples include euthanasia via transcardial perfusion or exsanguination by removal of the heart.

Record keeping requests

Animals undergoing any non-survival surgery must, at minimum, be listed under Pain Category D (pain/distress relieved by use of appropriate anesthetics, analgesics, tranquilizers, or by euthanasia) in the research protocol. This does not preclude listing these animals in Pain Category E (pain/distress cannot be relieved by use of anesthetics, analgesics, or tranquilizers, as the use of these agents would interfere with the experimental design) if the animals will undergo additional procedures that would appropriately fall under that category.

Ø  Records of all non-survival surgeries must be maintained in accord with USDA requirements and recommendations of the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International. These records must include the administration of anesthetics, fluids, and any drugs; details of the procedure, including intra-operative monitoring; the method of euthanasia, including all drugs administered to cause death; and the initials of the individual performing these tasks. All medications, including the name, dose, route, and time of administration must be recorded. Additionally, any adverse outcomes requiring euthanasia of the animal prior to completion of the procedure must be noted.

Post-Operative Analgesic and Antibiotic Treatment

Analgesics MUST be provided to all animals following major surgery unless scientific justification for withholding post-operative analgesics is provided by the investigator and approved by the IACUC, or if a veterinarian examines the animal and determines that analgesic administration is no longer necessary.

Ø  In cases where post-operative analgesics cannot be administered for scientific reasons, the animals must be listed in Pain Category E (i.e., pain/distress cannot be relieved by use of anesthetics, analgesics, or tranquilizers as the use of these agents would interfere with the experimental design).

ؠ The use of local pain-relieving drugs such as Marcaine® (bupivacaine), in addition to systemic analgesia, may be indicated for some procedures that will result in significant disruption of the skin (e.g., Alzet pump placement, catheter exteriorization), as these drugs may help to block the onset of the pain cascade due to disruption of the dermal nerve cells. Local analgesics are not intended for use in lieu of systemic analgesics, unless the withholding of systemic analgesia is scientifically justified.

Ø  Major survival surgeries require at least 48 hours of post-operative analgesia, and then as needed if the animal still appears to be in pain. For major survival surgeries, consultation with the veterinarian should also include consideration of pre-operative analgesia.

Ø  Minor procedures require at least 24 hours of post-operative analgesia, and then as needed if the animal still appears to be in pain.

- Link-

* NIH Guidelines for Survival Rodent Surgery http://oacu.od.nih.gov/ARAC/surguide.pdf

*NIH recommendation for aseptic technique and post-operative care for rodent surgery

http://www.ncifcrf.gov/rtp/lasp/intra/acuc/fred/guidelines/ACUC33AsepticSurgeryPostopCareAug08.pdf

* USDA Pain and Distress website:

https://www.nal.usda.gov/awic/reducing-pain-and-distress (Also see training section on NIH website: http://grants.nih.gov/grants/olaw/TrainingVideos.htm)

-Animal Welfare: https://www.aphis.usda.gov/aphis/ourfocus/animalwelfare/sa_publications/ct_publications_and_guidance_documents

*USDA Animal Welfare Act: https://www.aphis.usda.gov/aphis/ourfocus/animalwelfare/sa_awa/ct_awa_program_information

*Guide for the Care and Use of Laboratory Animals (p11-12, p60-64, p79, p64): http://www.nap.edu/openbook.php?record_id=5140

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SUPPLEMENTAL FORM 6

Surgery

The University at Albany – IACUC

11.08.16

PI NAME

** If your laboratory has written Standard Operation Procedures (SOPs) of surgery,
please cite SOP #. The IACUC strongly recommends that each laboratory have IACUC approved SOPs for all of experimental procedures **

If you have IACUC approved SOPs, you need only provide the SOP #

SURGICAL INFORMATION

1.  Indicate the category to which animals/species are assigned (check ALL applicable)

Major Surgery / Minor Surgery
Survival Surgery / Non- Survival Surgery
Single Procedure / Multiple Procedures

2.  If you have IACUC approved SOPs, please provide SOP number: SOP #

3.  Enter the complete name of the person(s) that will be involved with surgery and related procedures. For each, indicate the type and amount of previous experience related to pain/distress procedure. Also indicate the responsible individual(s) for post-operative care procedures.

Name / Position / Experience and Training

4.  Provide following information about surgery (if more than one type of surgery will be performed, fill out separate question for each one):

·  Name of the surgery to be conducted:

·  Place where the surgery/ procedure(s)will be conducted (building and room number):

·  Provide detailed procedure(s) of the surgery:

·  Name, dose, route, and timing of following agents-

Pre- Anesthetic
Agents / Name of agents / Dosage / Volume / Route / Frequency of Administration / Timing of Administration
Surgical
Agents / Name of agents / Dosage / Volume / Route / Frequency of Administration / Timing of Administration
Post- Operative
Agents / Name of agents / Dosage / Volume / Route / Frequency of Administration / Timing of Administration

5.  If you have pre-operative preparations (such as fasting, prophylactic antibiotics etc), provide information: [SOP #]

·  Types of preparation:

·  Preparing frequency and time:

·  Justification for the pre-operative preparations:

6.  Describe intra-operative procedures: [SOP #]

·  Aseptic technique (PPE and surgical instruments will utilized in the surgery) :

·  Surgical procedure:

·  Direction and Size of incisions: Dorsal // Ventral [Size]

·  Method of Wound closure:

·  Monitoring:

·  Other:

NOTE: Asepsis: A condition in which living pathogenic organisms are absent; a state of sterility.

Aseptic surgery: The performance of an operation with sterile gloves, instruments, etc., and utilizing precautions against the introduction of infectious microorganisms from without.

7.  Describe procedures of detection and management of post-operative complication:

[SOP #]

·  During work hours:

·  After work hours:

·  Weekends and holidays:

8.  Describe immediate post-operative (first 24hrs) care: [SOP #]

·  Animal Recovering procedure (caging, housing etc):

·  Monitoring:

·  Record keeping:

·  Other (such as special food, water etc):

·  If you using analgesia, please also provide information (name, route, dosage etc):

9.  Describe longer-term post-operative (10 to 14 days post-surgery) care: [SOP #]

·  Monitoring:

·  Suture / Wound clip removal:

·  Other (such as special food, water etc):

·  If you using analgesia, please also provide information (name, route, dosage etc):

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