Perianal FistulaPhase 4NCT03405922
Perianal Nerval Block in Proctological Interventions
A Phase 4 study testing 40 mL Ropivacain 0.5% in people with Perianal Fistula and Fissure in Ano, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The aim of this study is to evaluate whether a local perianal block performed during a proctological intervention can reduce the postoperative pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perianal Fistula, Fissure in Ano, Hemorrhoids
- What is being tested?
- 40 mL Ropivacain 0.5%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2018to 5 Jul 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with surgical indication for hemorrhoids, fistula-in-ano or anal fissures.
- Age of 18 or above
Who cannot join
- age under 18.
- Patients unable to understand an informed consent.
- Emergency operations
- Pregnant women.
- Patients with acute perianal infection.
- Patients allergic to any component of the local anesthetic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perianal Nerval Block in Proctological Interventions: a Prospective Randomized Double Blinded Study
The aim of this study is to evaluate whether a local perianal block performed during a proctological intervention can reduce the postoperative pain.
Read the detailed description
The aim of this study is to evaluate whether a local perianal block performed during a proctological intervention can reduce the postoperative pain.
All patients will undergo surgery under general or spinal anesthesia. At the end of the surgery, the surgeon will perform a perianal block using the local anesthetic or the placebo upon randomisation. The experimental group will receive a local anesthetics and the control group a normal saline injection. All injections will be perianal, peripheral to the external anal sphincter.
- Conditions
- Perianal Fistula, Fissure in Ano, Hemorrhoids
- Being tested
- Placebo 40 mL Saline 0.9%, 40 mL Ropivacain 0.5%
- Medical subject headings
- Fissure in Ano, Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo 40 mL Saline 0.9%Drug
Injection of 40 mL 0.9% saline
40 mL Ropivacain 0.5%Drug
Ropivacaine Hcl 0.5% Injection 40 mL
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo 40 mL Saline 0.9% Receives: Drug: Placebo 40 mL Saline 0.9% |
| Ropivacain | Active comparator | 40 mL Ropivacain 0.5% Receives: Drug: 40 mL Ropivacain 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Postoperative Pain assessed by visual analogue scale (max. 10, min.0 points, range: 0-10; 0 = no pain at all, 10 = worst pain ever experienced)
Measured: 24 hours post-surgery
Secondary outcomes (1)
Quality of Life assessed by questionnaire
Quality of Life assessed by questionnaire
Measured: 2 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Feb 2018
- Primary completion5 Jul 2019
- Study completion5 Jul 2019
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 Perianal FistulaStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Steinemann, Principal investigator, St:Claraspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405922
- Sponsor's protocol ID
- Perianal block in proctology
- Status last verified
- Jul 2019
- First submitted
- 12 Jan 2018
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rotigliano N, Fuglistaler I, Guenin MO, Dursunoglu GB, Freiermuth D, von Flue M, Steinemann DC. Perianal block with ropivacaine as a supplement to anaesthesia in proctological surgery: double-blind randomized placebo-controlled trial (PERCEPT). Br J Surg. 2020 Jul;107(8):960-969. doi: 10.1002/bjs.11520. Epub 2020 Mar 18.
PubMed 32187663
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perianal Nerval Block in Proctological Interventions: a Prospective Randomized Double Blinded Study
- ClinicalTrials.gov ID
- NCT03405922
- Acronym / sponsor ID
- Perianal block in proctology
- Conditions
- Perianal Fistula, Fissure in Ano, Hemorrhoids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 5 Jul 2019 (actual)
- Study completion
- 5 Jul 2019 (actual)
- First posted
- 23 Jan 2018 (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 aim of this study is to evaluate whether a local perianal block performed during a proctological intervention can reduce the postoperative pain.
Detailed description
The aim of this study is to evaluate whether a local perianal block performed during a proctological intervention can reduce the postoperative pain.
All patients will undergo surgery under general or spinal anesthesia. At the end of the surgery, the surgeon will perform a perianal block using the local anesthetic or the placebo upon randomisation. The experimental group will receive a local anesthetics and the control group a normal saline injection. All injections will be perianal, peripheral to the external anal sphincter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo 40 mL Saline 0.9%Placebo 40 mL Saline 0.9% |
| Ropivacain | Active comparator | Drug: 40 mL Ropivacain 0.5%40 mL Ropivacain 0.5% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with surgical indication for hemorrhoids, fistula-in-ano or anal fissures.
- Age of 18 or above
Key exclusion criteria (6 listed)
- age under 18.
- Patients unable to understand an informed consent.
- Emergency operations
- Pregnant women.
- Patients with acute perianal infection.
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 |
|---|---|---|
| Placebo 40 mL Saline 0.9%Injection of 40 mL 0.9% saline | Drug | Placebo |
| 40 mL Ropivacain 0.5%Ropivacaine Hcl 0.5% Injection 40 mL | Drug | Ropivacain |
Primary outcome
Postoperative Pain
Time frame: 24 hours post-surgery
Postoperative Pain assessed by visual analogue scale (max. 10, min.0 points, range: 0-10; 0 = no pain at all, 10 = worst pain ever experienced)
1 secondary outcome
Quality of Life assessed by questionnaire
Time frame: 2 weeks post-surgery
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 10 Jul 2019.
- Derived from this study: PubMed 32187663Rotigliano N, Fuglistaler I, Guenin MO, Dursunoglu GB, Freiermuth D, von Flue M, Steinemann DC. Perianal block with ropivacaine as a supplement to anaesthesia in proctological surgery: double-blind randomized placebo-controlled trial (PERCEPT). Br J Surg. 2020 Jul;107(8):960-969. doi: 10.1002/bjs.11520. Epub 2020 Mar 18.
- Individual participant dataSharing planned: No
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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.
Daniel Steinemann principal investigator
St:Claraspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 40 mL Ropivacain 0.5% in people with Perianal Fistula and Fissure in Ano, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 2 inclusion and 6 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 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 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?
Postoperative Pain (time frame: 24 hours post-surgery). 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 NCT03405922, 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 10 Jul 2019.