Pre-Emptive Analgesia in Ano-Rectal Surgery

NCT02402543 | Completed DMC

• 1 other identifier: CHRMS: M13-226
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hemorrhoids; Fissure in Ano; Rectal Fistula; Anal Condyloma

Keywords

preemptive analgesia; anorectal surgery; gabapentin; neurontin; ketamine; acetaminophen; tylenol; postoperative pain; postoperative narcotic usage; dexamethasone; decadron

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  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.

  End of surgery up to 7 days postoperatively

Secondary Outcomes (3)

• Narcotic consumption

  End of surgery up to 7 days postoperatively

• Interval for rescue pain medication

  End of surgery up to 7 days postoperatively

• Further pain requirements

  End of surgery up to 7 days postoperatively

Study Arms (2)

Control Arm

PLACEBO COMPARATOR

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 Arm

EXPERIMENTAL

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; Drug: Ketamine; Drug: Acetaminophen; Drug: Dexamethasone

Interventions

Gabapentin DRUG

Also known as: Neurontin, Gralise, Fanatrex

Experimental Arm

Ketamine DRUG

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.

Also known as: Ketalar

Experimental Arm

Acetaminophen DRUG

Also known as: Tylenol, panadol, mapap, ofirmev, tempra

Experimental Arm

Dexamethasone DRUG

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.

Also known as: Decadron,

Experimental Arm

Placebo DRUG

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead
• American Society of Colon and Rectal Surgeons: collaborator

Study Sites (2)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

University of Vermont Medical Center Fanny Allen Campus

Colchester, Vermont, 05446, United States

Location

Related Publications (41)

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MeSH Terms

Conditions

Hemorrhoids; Fissure in Ano; Rectal Fistula; Pain, Postoperative

Interventions

Gabapentin; Ketamine; Acetaminophen; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Anus Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Acetanilides; Anilides; Amides; Aniline Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery and Principal Investigator

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: March 30, 2015
• Study Start: June 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: January 16, 2018

Record last verified: 2018-01

Locations

US (2)