Pain, AcuteNCT04953182
Pain Modality Treatment After Hemorrhoidectomy
An observational study of Pain, Acute and Pain, Procedural, run by Assuta Medical Center.
Trial summary
Hemorrhoidectomy is one of the operations that causes the greatest intensity of pain. Treatment of postoperative pain is essential for the well-being of the patient. Long-term use of opioids and different drugs can have unintended consequences. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain, Acute, Pain, Procedural
- What is being tested?
- Pain scale registry
- How many people
- 5,335 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 30 May 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients that underwent elective hemorrhoidectomy
Who may be able to join
- Elective surgery for hemorrhoids
Who cannot join
- Mental retardation Incapacitated patient Under 18 years old
About this study
Official title: Around the Clock Pain Treatment Modality Offer Better Pain Control and Less Opiates Drugs Use
Hemorrhoidectomy is one of the operations that causes the greatest intensity of pain. Treatment of postoperative pain is essential for the well-being of the patient. Long-term use of opioids and different drugs can have unintended consequences.
The objective is to corroborate which pain treatment modality is better in patients after hemorrhoidectomy.
Read the detailed description
Patients who have undergone a hemorrhoidectomy are included in the study, the pain treatment modality is conceived by the treating surgeon or anesthesiologist. The first modality is to administer pain killers on-demand depending on visual analog scales of pain and the second modality to give pain killers on determined hours.
- Conditions
- Pain, Acute, Pain, Procedural
- Being tested
- Pain scale registry
- Keywords
- Pain killers
- Medical subject headings
- Acute Pain, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain scale registryOther
The nurses ask the patient about the pain filling every two hours during the hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| Around the clock analgetic treatment | Patients that underwent hemorrhoidectomy and pain killers are prescribed every specific hour independent of pain degree, if necessary drugs can be administered on demand. Receives: Other: Pain scale registry | |
| On demand analgetic treatment | A pain killers list is prescribed by the physician and the nurse decides which drug to administer depending on a protocol of treatment based on the visual analog scale. Receives: Other: Pain scale registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain medition
The pain registred is analyze as maximum, mean and on discharge.
Measured: Immediately after the intervention/procedure/surgery
Drugs Administred
The amount of drugs administred to each patients is analyzed
Measured: Immediately after the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start1 Jul 2016
- Primary completion31 Dec 2020
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Gabriel Susmallian, Assuta Medical Center
- Investigators
- Sergio G Susmallian, MD, Principal investigator, Assuta Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953182
- Sponsor's protocol ID
- 12-2020
- Status last verified
- Jul 2021
- First submitted
- 26 Jun 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be sent to the accepting journal study
Publications
Susmallian S, Aviv I, Babis I, Segal E. Analysis of Two Treatment Modalities for Post-surgical Pain after Hemorrhoidectomy. Chirurgia (Bucur). 2024 Jun;119(3):247-259. doi: 10.21614/chirurgia.2024.v.119.i.3.p.247.
PubMed 38982903
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Around the Clock Pain Treatment Modality Offer Better Pain Control and Less Opiates Drugs Use
- ClinicalTrials.gov ID
- NCT04953182
- Acronym / sponsor ID
- 12-2020
- Conditions
- Pain, Acute, Pain, Procedural
- Keywords
- Pain killers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,335 participants (actual)
- Lead sponsor
- Assuta Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 7 Jul 2021 (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.
Hemorrhoidectomy is one of the operations that causes the greatest intensity of pain. Treatment of postoperative pain is essential for the well-being of the patient. Long-term use of opioids and different drugs can have unintended consequences.
The objective is to corroborate which pain treatment modality is better in patients after hemorrhoidectomy.
Detailed description
Patients who have undergone a hemorrhoidectomy are included in the study, the pain treatment modality is conceived by the treating surgeon or anesthesiologist. The first modality is to administer pain killers on-demand depending on visual analog scales of pain and the second modality to give pain killers on determined hours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Around the clock analgetic treatment | – | Other: Pain scale registryPatients that underwent hemorrhoidectomy and pain killers are prescribed every specific hour independent of pain degree, if necessary drugs can be administered on demand. |
| On demand analgetic treatment | – | Other: Pain scale registryA pain killers list is prescribed by the physician and the nurse decides which drug to administer depending on a protocol of treatment based on the visual analog scale. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients that underwent elective hemorrhoidectomy
Key inclusion criteria (1 listed)
- Elective surgery for hemorrhoids
Key exclusion criteria (1 listed)
- Mental retardation Incapacitated patient Under 18 years old
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 |
|---|---|---|
| Pain scale registryThe nurses ask the patient about the pain filling every two hours during the hospitalization. | Other | Around the clock analgetic treatment, On demand analgetic treatment |
Primary outcome
Pain medition
Time frame: Immediately after the intervention/procedure/surgery
The pain registred is analyze as maximum, mean and on discharge.
Drugs Administred
Time frame: Immediately after the intervention/procedure/surgery
The amount of drugs administred to each patients is analyzed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Derived from this study: PubMed 38982903Susmallian S, Aviv I, Babis I, Segal E. Analysis of Two Treatment Modalities for Post-surgical Pain after Hemorrhoidectomy. Chirurgia (Bucur). 2024 Jun;119(3):247-259. doi: 10.21614/chirurgia.2024.v.119.i.3.p.247.
- Individual participant dataSharing planned: No. The data will be sent to the accepting journal study
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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.
Sergio G Susmallian, MD principal investigator
Assuta Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Acute and Pain, Procedural, run by Assuta Medical Center.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 Jul 2021. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain medition (time frame: Immediately after the intervention/procedure/surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04953182, which also lists 1 linked publication.
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 7 Jul 2021.