This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Multi-Drug Analgesia vs. Standard Solution for Anal Surgery

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified April 2017 by Emmanouil Pappou, Columbia University
Sponsor:
Information provided by (Responsible Party):
Emmanouil Pappou, Columbia University
ClinicalTrials.gov Identifier:
NCT03105674
First received: March 16, 2017
Last updated: April 3, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Hemorrhoids Fissure in Ano Fistula;Rectal Drug: Multi-drug local anesthetics (Combination) Drug: Standard local anesthetics (Combination) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Supportive Care
Official Title: Multi-drug Analgesia Versus Standard Solution for Perianal Block - A Prospective Study to Determine the Efficacy, Cost and Narcotic Consumption in the Post-operative Period

Resource links provided by NLM:


Further study details as provided by Emmanouil Pappou, Columbia University:

Primary Outcome Measures:
  • Score on Numeric Pain Rating Scale [ Time Frame: Up to 7 days post-surgery ]
    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.


Estimated Enrollment: 100
Anticipated Study Start Date: May 1, 2017
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Therapy
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)
Marcaine and Lidocaine
Other Name: Standard solution
Experimental: Multi-drug local anaesthetics

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)
  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
Other Name: Peri-anal block

Detailed Description:
Post-operative analgesia after anorectal surgery still poses a significant problem. Technical or operator dependent factors have been proposed for causing severe pain post operatively. Many factors such as height of anastomosis, incorporation of smooth muscle, size of doughnut, and inclusion of squamous epithelium were considered to cause pain specially after hemorrhoidectomy. However, in spite of standardizing the techniques, patients still experience moderate to severe pain after anorectal surgery. Effective post-surgical pain control is critical to patient recovery, and can contribute to improved healing, faster patient mobilization, reduced hospital stays and health care costs. Effective multimodal techniques have been devised to maximize pain relief, lower the risk of adverse events, and improve patient outcomes. These techniques (wound infiltration with local anesthetic being most common) is short lived, maximum up to 12 hours. Post-operative pain usually lasts for 72 hours and thus the systemic opioids remain the mainstay pain control post-operatively. Although effective analgesics, they are associated with unwanted and potentially adverse events, such as nausea, vomiting, pruritus, sedation, cognitive impairment, urinary retention, sleep disturbances, and respiratory depression. Also, narcotic addiction remains a concern for surgical patients. Some patients would like to have effective analgesia and thus also avoid narcotics.Multi-drug analgesic combinations are used in orthopedic surgery (Ropivacaine, Ketorolac, and Morphine, with adrenaline) and during hemorrhoidectomy (extended-release liposome Bupivacaine) which showed decrease in post-operative analgesia requirement. However, no studies that used multi-drug analgesia show any effect on the pain medication consumption after discharge for ambulatory surgery. The investigators have designed a novel multi-drug anesthetic formulation to achieve long-acting postoperative analgesia with single-dose administration intra-operative via perianal block and wound infiltration.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03105674

Contacts
Contact: Emmanouil Pappou, MD, PhD (212) 345-1155 ep2768@cumc.columbia.edu
Contact: Kunal Suradkar (347) 393-6974 ks3351@cumc.columbia.edu

Locations
United States, New York
Columbia University Medical Center Not yet recruiting
New York, New York, United States, 10032
Contact: Ravi P Kiran, MBBS, MD, MS    212-345-1155    rpk2118@cumc.columbia.edu   
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Emmanouil Pappou, MD, PhD Columbia University
  More Information

Responsible Party: Emmanouil Pappou, Assistant Professor of Surgery, Columbia University
ClinicalTrials.gov Identifier: NCT03105674     History of Changes
Other Study ID Numbers: AAAQ9398
Study First Received: March 16, 2017
Last Updated: April 3, 2017
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: To be decided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Emmanouil Pappou, Columbia University:
analgesia
peri-anal procedure
peri-anal block
anal surgery

Additional relevant MeSH terms:
Fistula
Hemorrhoids
Fissure in Ano
Rectal Fistula
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Anus Diseases
Intestinal Fistula
Digestive System Fistula
Pharmaceutical Solutions
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 26, 2017