Multi-Drug Analgesia vs. Standard Solution for Anal Surgery

NCT03105674 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: AAAQ9398
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary aim is to test the magnitude and duration of analgesia provided by single dose multi-drug analgesia administered for perianal block, and compare with standard solution (Marcaine \& Lidocaine in 1:1 mixture - Total 60 ml), at post-operative period and also to compare with the standard solution including their respective post-operative opioid or non-opioid oral analgesic requirement. Local anesthesia via a perianal block using multi-drug analgesia or standard solution will be compared using the Numeric pain rating scale on Post-operative day 1, 3 and during follow up visit on day 7. The investigators hope to find a better control of post-operative analgesia which will lead to better functional outcomes. Possible decrease consumption of opioids in the post-operative period will perhaps decrease the cost and chances of addiction and will increase patient comfort and compliance.

Conditions

Hemorrhoids; Fissure in Ano; Fistula;Rectal

Keywords

analgesia; peri-anal procedure; peri-anal block; anal surgery

Outcome Measures

Primary Outcomes (1)

• Score on Numeric Pain Rating Scale

  A Numeric pain rating scale will be given to the patient on post-operative day (POD) # 1 before discharge and during follow up on POD # 7, and they will be telephoned on subsequent days from discharge till POD # 3 at regular intervals.

  Up to 7 days post-surgery

Study Arms (2)

Standard Therapy

ACTIVE COMPARATOR

Patients will receive a combination of Marcaine and Lidocaine injection (standard local anesthetics) as a part of their peri-anal block prior to the surgery.

Drug: Standard local anesthetics (Combination)

Multi-drug local anaesthetics

EXPERIMENTAL

Patients will receive a combination \[Multi-drug local anesthetics (Combination)\] of following drugs as a part of their peri-anal block prior to the surgery (multi-drug local anesthetics) 1. Ropivacaine 0.5% - 30 ml 2. Ketorolac 30mg/ml - 1 ml 3. Kenalog 10 mg/ml - 5 ml 4. Lidocaine 1% with Epinephrine 1:100,000 - 20ml

Drug: Multi-drug local anesthetics (Combination)

Interventions

Multi-drug local anesthetics (Combination) DRUG

1. Ropivacaine 0.5% - 30 ml 2. Ketorolac 30mg/ml - 1 ml 3. Kenalog 10 mg/ml - 5 ml 4. Lidocaine 1% with Epinephrine 1:100,000 - 20ml

Also known as: Peri-anal block

Multi-drug local anaesthetics

Standard local anesthetics (Combination) DRUG

Marcaine and Lidocaine

Also known as: Standard solution

Standard Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and nonpregnant women aged 18 years or older scheduled to undergo anorectal procedures
• Female patients must be postmenopausal, surgically sterile, or willing to use acceptable means of contraception for at least 30 days after surgery.
• Patients will be required to have an Americal society of anesthesia physical status classification of 1, 2, or 3.

You may not qualify if:

• Patients with concurrent or recent medical conditions that might interfere with study participation, including history of hepatitis, alcohol/substance abuse, uncontrolled psychiatric disorders, known allergy, or contraindication to amide-type local anesthetics, opioids, or propofol.
• Patients who are participating in another study involving an investigational medication within the prior 30 days, or were taking analgesics (ie, non- steroidal anti-inflammatory drugs, acetaminophen, or opioids), antidepressants, or glucocorticoids within the 3 days before surgery.

Sponsors & Collaborators

• Columbia University: lead

MeSH Terms

Conditions

Hemorrhoids; Fissure in Ano; Rectal Fistula; Agnosia

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; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Emmanouil Pappou, MD, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: April 10, 2017
• Study Start: May 1, 2017
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 25, 2017

Record last verified: 2017-07