HemorrhoidsPhase 4NCT03105674
Multi-Drug Analgesia vs. Standard Solution for Anal Surgery
A Phase 4 study testing Multi-drug local anesthetics (Combination) and Standard local anesthetics (Combination) in people with Hemorrhoids and Fissure in Ano, run by Columbia University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhoids, Fissure in Ano, Fistula;Rectal
- What is being tested?
- Multi-drug local anesthetics (Combination) and Standard local anesthetics (Combination)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2017to Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
Read the 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.
- Conditions
- Hemorrhoids, Fissure in Ano, Fistula;Rectal
- Being tested
- Multi-drug local anesthetics (Combination), Standard local anesthetics (Combination)
- Keywords
- analgesia, peri-anal procedure, peri-anal block, anal surgery
- Medical subject headings
- Hemorrhoids, Fissure in Ano, Rectal Fistula, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-drug local anesthetics (Combination)Drug
Also called Peri-anal block
- Ropivacaine 0.5% - 30 ml
- Ketorolac 30mg/ml - 1 ml
- Kenalog 10 mg/ml - 5 ml
- Lidocaine 1% with Epinephrine 1:100,000 - 20ml
Standard local anesthetics (Combination)Drug
Also called Standard solution
Marcaine and Lidocaine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Multi-drug local anesthetics (Combination) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 7 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start1 May 2017 (estimated)
- Primary completionNov 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Not yet IRB approved and PI will be leaving institution in September.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanouil Pappou, MD, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105674
- Sponsor's protocol ID
- AAAQ9398
- Status last verified
- Jul 2017
- First submitted
- 16 Mar 2017
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be decided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03105674
- Acronym / sponsor ID
- AAAQ9398
- Conditions
- Hemorrhoids, Fissure in Ano, Fistula;Rectal
- Keywords
- analgesia, peri-anal procedure, peri-anal block, anal surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not yet IRB approved and PI will be leaving institution in September.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (estimated)
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy | Active comparator | Drug: Standard local anesthetics (Combination)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. |
| Multi-drug local anaesthetics | Experimental | Drug: Multi-drug local anesthetics (Combination)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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-drug local anesthetics (Combination)Also: Peri-anal block1. 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 anaesthetics |
| Standard local anesthetics (Combination)Also: Standard solutionMarcaine and Lidocaine | Drug | Standard Therapy |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Individual participant dataSharing planned: Undecided. To be decided
Related trials for Hemorrhoids
Not yet recruiting
Auricular Indwelling Needles Added to Diosmin/Hesperidin for Grade I-II Internal Hemorrhoids With Heat-Toxin Syndrome
Internal Haemorrhoids
Enrolling by invitation
Ultrasound-Guided Versus Landmark-Guided Pudendal Block for Post-Hemorrhoidectomy Pain
Hemorrhoids, Postoperative Pain
Not yet recruitingObservational study
Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment
Hemorrhoid, Hemorrhoid Bleeding
Recruiting
Ligasure Versus Conventional Diathermy in Hemorrhoidectomy
Hemorrhoids
Recruiting
The Use of Electronic Bidets Compared to Water Rinsing After Surgery for Anal Fistula or Haemorrhoidal Disease: a Pilot Study
Anal Fistula Surgery, Anal Fistula
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanouil Pappou, MD, PhD principal investigator
Columbia University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Multi-drug local anesthetics (Combination) and Standard local anesthetics (Combination) in people with Hemorrhoids and Fissure in Ano, run by Columbia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on Numeric Pain Rating Scale (time frame: Up to 7 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2017.