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Pre-Emptive Analgesia in Ano-Rectal Surgery (PEAARS)

This study is currently recruiting participants.
Verified May 2016 by Peter Cataldo, MD, University of Vermont
Sponsor:
ClinicalTrials.gov Identifier:
NCT02402543
First Posted: March 30, 2015
Last Update Posted: May 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
American Society of Colon and Rectal Surgeons
Information provided by (Responsible Party):
Peter Cataldo, MD, University of Vermont
  Purpose

The perianal region is the region around the anus. Administering a pain medication before a surgery starts is called preemptive analgesia. In some studies, this technique has been shown to be an effective way to reduce the pain that a patient experiences in the post-operative timeframe to a greater extent than would be expected simply from the pain medications alone. One theory of why this occurs suggests that the preemptive analgesia desensitizes brain and nerves to pain, thereby decreasing the response to painful stimuli, like surgery when they occur. This leads to a decrease in the amount of narcotic pain medication required after the procedure, which leads to less side effects and a quicker return to normal functioning. As perianal surgeries do not usually include a long stay in the hospital, controlling post-procedure pain is a priority.

The use of preemptive analgesia is in other types of surgeries, such as orthopedics, is well established, but as the perianal region has not been well studied, its use is not the standard of care. This type of analgesia uses a combination of medications that are already in use for post-operative and non-operative pain control and administers them orally prior to the patient undergoing general anesthesia. The side effects of the medications are the same as if they had been given after surgery or for non-surgical pain.

The concept of preemptive analgesia is established in other types of surgeries and it has solid basic science to support its use. The purpose of this randomized, double-blind, placebo controlled study is to determine if patients undergoing perianal surgeries could benefit from preemptive pain control. The primary outcome will be whether patients experience less post-operative pain. Patient post-operative consumption and latency until use of narcotic pain medication will be the secondary outcomes. The investigators believe that the patients receiving pain medications before their operation will require less pain medication after surgery, with minimal increased risk to the patient.


Condition Intervention
Hemorrhoids Fissure in Ano Rectal Fistula Anal Condyloma Drug: Gabapentin Drug: Ketamine Drug: Acetaminophen Drug: Dexamethasone Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pre-Emptive Analgesia in Ano-Rectal Surgery

Further study details as provided by Peter Cataldo, MD, University of Vermont:

Primary Outcome Measures:
  • Postoperative pain [ Time Frame: End of surgery up to 7 days postoperatively ]
    Pain will be evaluated using numerical rating scales at specified intervals from the end of surgery up to 7 days postoperatively and mailed back to the investigators. The pain levels will be compared between groups.


Secondary Outcome Measures:
  • Narcotic consumption [ Time Frame: End of surgery up to 7 days postoperatively ]
    Narcotic consumption will be recorded by the subject on medication diaries attached to the respective numerical rating scale. This helps to identify at which time point the patient took a narcotic. This will be compared between groups.

  • Interval for rescue pain medication [ Time Frame: End of surgery up to 7 days postoperatively ]
    On the aforementioned medication diaries, the patient will record when he or she first needed break through pain medication (i.e. the narcotic prescribed) beyond the scheduled pain medicines. This will help us evaluate the interval between end of the operation and first need for breakthrough pain medication. This number will be compared between groups.

  • Further pain requirements [ Time Frame: End of surgery up to 7 days postoperatively ]
    By examining the medication diaries, we will be able to evaluate if there were patients who required more than the scheduled pain medications and breakthrough narcotic. This number will be compared between groups.


Estimated Enrollment: 90
Study Start Date: June 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control Arm
In pre-op, the subject is administered four placebo pills PO containing confectioners sugar, which are matched in color, size, and shape to the active pills.
Drug: Placebo
Experimental: Experimental Arm
In pre-op, the subject is administered four pills PO containing a total of 1000 mg of acetaminophen and 600 mg of gabapentin, which are matched in color, size, and shape to the placebo pills.
Drug: Gabapentin
Other Name: Neurontin, Gralise, Fanatrex
Drug: Ketamine
Prior to the incision in the operating room, the anesthesiologist administers 0.15 mg/kg of ketamine IV push in patients randomized to the experimental arm, only.
Other Name: Ketalar
Drug: Acetaminophen
Other Name: Tylenol, panadol, mapap, ofirmev, tempra
Drug: Dexamethasone
Prior to the incision in the operating room, the anesthesiologist administers 8 mg of dexamethasone IV push in patients randomized to the experimental arm, only.
Other Name: Decadron,

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients having anal fistula repairs for anal fistulas recalcitrant to non-surgical management at the University of Vermont Medical Center or Fanny Allen Campuses OR
  • Patients having anal sphincterotomies for chronic anal fissures recalcitrant to non-surgical management at the University of Vermont Medical Center or Fanny Allen Campuses OR
  • Patients having hemorrhoidectomies for hemorrhoids recalcitrant to non-surgical management at the University of Vermont Medical Center or Fanny Allen Campuses OR
  • Patients having anal condyloma excisions for anal condylomas recalcitrant to non-surgical management at the University of Vermont Medical Center or Fanny Allen Campuses
  • Patients undergoing these surgeries must be American Society of Anesthesiologists (ASA) Physical Status Classification System scores of I (normal, healthy patient), II (patient with mild, systemic disease), or III (patients with more significant disease)

Exclusion Criteria:

  • Allergies to any study medications;
  • Patient history and chart review for existence of hepatic or renal failure;
  • Chronic pain syndrome;
  • Inability to understand or utilize the Numerical Rating Scale (NRS);
  • Pregnancy;
  • Patients currently on gabapentin, pregabalin or narcotics
  • Patients taking chronic steroids, unable to taper off before surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02402543


Contacts
Contact: Karen Lepuschenko, BS, CCRC 802-656-9924 karen.lepuschenko@med.uvm.edu
Contact: Hannah Eldred, BS 802-656-9441 hannah.eldred@med.uvm.edu

Locations
United States, Vermont
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05401
Contact: Karen Lepuschenko, BS, CCRC    802-656-9924    karen.lepuschenko@med.uvm.edu   
Contact: Hannah Eldred, BS    802-656-9441    hannah.eldred@med.uvm.edu   
Principal Investigator: Peter Cataldo, MD         
Sub-Investigator: Gino Trevisani, MD         
Sub-Investigator: Jesse Moore, MD         
University of Vermont Medical Center Fanny Allen Campus Recruiting
Colchester, Vermont, United States, 05446
Contact: Karen Lepuschenko, BS, CCRC    802-656-9924    karen.lepuschenko@med.uvm.edu   
Contact: Hannah Eldred, BS    802-656-9441    hannah.eldred@med.uvm.edu   
Principal Investigator: Peter Cataldo, MD         
Sub-Investigator: Gino Trevisani, MD         
Sub-Investigator: Jesse Moore, MD         
Sponsors and Collaborators
University of Vermont
American Society of Colon and Rectal Surgeons
  More Information

Publications:

Responsible Party: Peter Cataldo, MD, Professor of Surgery and Principal Investigator, University of Vermont
ClinicalTrials.gov Identifier: NCT02402543     History of Changes
Other Study ID Numbers: CHRMS: M13-226
First Submitted: March 25, 2015
First Posted: March 30, 2015
Last Update Posted: May 17, 2016
Last Verified: May 2016

Keywords provided by Peter Cataldo, MD, University of Vermont:
preemptive analgesia
anorectal surgery
gabapentin
neurontin
ketamine
acetaminophen
tylenol
postoperative pain
postoperative narcotic usage
dexamethasone
decadron

Additional relevant MeSH terms:
Fistula
Hemorrhoids
Rectal Fistula
Fissure in Ano
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Intestinal Fistula
Digestive System Fistula
Anus Diseases
Dexamethasone acetate
Dexamethasone
Ketamine
Acetaminophen
Gabapentin
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal