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Multi-Drug Analgesia vs. Standard Solution for Anal Surgery

Primary Purpose

Hemorrhoids, Fissure in Ano, Fistula;Rectal

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Multi-drug local anesthetics (Combination)
Standard local anesthetics (Combination)
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hemorrhoids focused on measuring analgesia, peri-anal procedure, peri-anal block, anal surgery

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Standard Therapy

    Multi-drug local anaesthetics

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 16, 2017
    Last Updated
    July 21, 2017
    Sponsor
    Columbia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03105674
    Brief Title
    Multi-Drug Analgesia vs. Standard Solution for Anal Surgery
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Not yet IRB approved and PI will be leaving institution in September.
    Study Start Date
    May 1, 2017 (Anticipated)
    Primary Completion Date
    November 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Columbia University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemorrhoids, Fissure in Ano, Fistula;Rectal
    Keywords
    analgesia, peri-anal procedure, peri-anal block, anal surgery

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard Therapy
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Multi-drug local anaesthetics
    Arm Type
    Experimental
    Arm Description
    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) Ropivacaine 0.5% - 30 ml Ketorolac 30mg/ml - 1 ml Kenalog 10 mg/ml - 5 ml Lidocaine 1% with Epinephrine 1:100,000 - 20ml
    Intervention Type
    Drug
    Intervention Name(s)
    Multi-drug local anesthetics (Combination)
    Other Intervention Name(s)
    Peri-anal block
    Intervention Description
    Ropivacaine 0.5% - 30 ml Ketorolac 30mg/ml - 1 ml Kenalog 10 mg/ml - 5 ml Lidocaine 1% with Epinephrine 1:100,000 - 20ml
    Intervention Type
    Drug
    Intervention Name(s)
    Standard local anesthetics (Combination)
    Other Intervention Name(s)
    Standard solution
    Intervention Description
    Marcaine and Lidocaine
    Primary Outcome Measure Information:
    Title
    Score on Numeric Pain Rating Scale
    Description
    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.
    Time Frame
    Up to 7 days post-surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Emmanouil Pappou, MD, PhD
    Organizational Affiliation
    Columbia University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    To be decided

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