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Withdrawn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
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
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
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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Multi-Drug Analgesia vs. Standard Solution for Anal Surgery
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