HemorrhoidNCT01927874
Subarachnoid or Infiltration for Hemorrhoidectomy
A study testing Infiltration, Spinal block and Bupivacaine in people with Hemorrhoid, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
There will be compared the postoperative analgesic effect of infiltration or spinal block for hemorrhoidectomy Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hemorrhoid
- What is being tested?
- Infiltration, Spinal block and Bupivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2013to Nov 2015
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Will be included 50 patients, ASA physical status 1 or 2 undergoing hemorrhoidectomy after approval by the Ethics Committee and signed Consent Form
Who cannot join
- There will be excluded patients with associated diseases (fistula, fissure), infection at the puncture site, using anticoagulants or analgesics (up to 2 weeks before the procedure) and pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of the Analgesic Effect of Subarachnoid or Infiltration for Hemorrhoidectomy
There will be compared the postoperative analgesic effect of infiltration or spinal block for hemorrhoidectomy
Read the detailed description
This is a prospective, randomized study, including 40 patients between 18 and 60 years, of both genders, ASA 1 or 2.
Patients in group 1 (n = 20) will be submitted to spinal block and group 2 (n = 20) to infiltration. The spinal block will be performed with 10 mg of 0.5% bupivacaine. The infiltration will be performed with 10 ml of 0.5% bupivacaine with epinephrine on each side.
Will be evaluated: intensity of pain on a numerical scale from 0 to 10 every 15 minutes, relaxation of the sphincter muscles, intensity of pain after the operation every 30 minutes until reached the criteria for discharge, muscle strength of the lower limbs every 30 minutes, BP, HR, SO2, FR, other items that determine the conditions of discharge (urine output, nausea and vomiting), time to hospital discharge, and duration of analgesia. Adverse effects and complications will be noted.
- Conditions
- Hemorrhoid
- Being tested
- Infiltration, Spinal block, Bupivacaine, 10 mg of hyperbaric 0.5% bupivacaine
- Keywords
- infiltration, hemorrhoidectomy, Postoperative pain
- Medical subject headings
- Hemorrhoids, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfiltrationProcedure or surgery
Also called Local Infiltration
injection of local anesthetic, associated with general anesthesia
Spinal blockProcedure or surgery
Also called subarachnoidal block
injection of anesthetic
BupivacaineDrug
Also called Local infiltration
10ml 0.5% bupivacaine.
10 mg of hyperbaric 0.5% bupivacaineDrug
Also called spinal anesthesia
Spinal punction and injection of local anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Infiltration, analgesic effect | Active comparator | 10ml 0.5% bupivacaine each side Block Injection of local anesthetic at pudendal nerve Receives: Procedure: Infiltration; Drug: Bupivacaine |
| Spinal block | Active comparator | 10 mg of hyperbaric 0.5% bupivacaine Injection of anesthetic at subarachnoidal space Receives: Procedure: Spinal block; Drug: 10 mg of hyperbaric 0.5% bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Numerical score
Measured: 24 hours
Secondary outcomes (1)
Time to discharge
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study startJan 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rioko Kimiko Sakata, Federal University of São Paulo
- Investigators
- Rioko K Sakata, PhD, Principal investigator, Universidade Federal de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927874
- Sponsor's protocol ID
- Bl.Pud
- Status last verified
- Feb 2016
- First submitted
- 23 Aug 2012
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Analgesic Effect of Subarachnoid or Infiltration for Hemorrhoidectomy
- ClinicalTrials.gov ID
- NCT01927874
- Acronym / sponsor ID
- Bl.Pud
- Conditions
- Hemorrhoid
- Keywords
- infiltration, hemorrhoidectomy, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 23 Aug 2013 (estimated)
- 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.
There will be compared the postoperative analgesic effect of infiltration or spinal block for hemorrhoidectomy
Detailed description
This is a prospective, randomized study, including 40 patients between 18 and 60 years, of both genders, ASA 1 or 2.
Patients in group 1 (n = 20) will be submitted to spinal block and group 2 (n = 20) to infiltration. The spinal block will be performed with 10 mg of 0.5% bupivacaine. The infiltration will be performed with 10 ml of 0.5% bupivacaine with epinephrine on each side.
Will be evaluated: intensity of pain on a numerical scale from 0 to 10 every 15 minutes, relaxation of the sphincter muscles, intensity of pain after the operation every 30 minutes until reached the criteria for discharge, muscle strength of the lower limbs every 30 minutes, BP, HR, SO2, FR, other items that determine the conditions of discharge (urine output, nausea and vomiting), time to hospital discharge, and duration of analgesia. Adverse effects and complications will be noted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infiltration, analgesic effect | Active comparator | Procedure: Infiltration, Drug: Bupivacaine10ml 0.5% bupivacaine each side Block Injection of local anesthetic at pudendal nerve |
| Spinal block | Active comparator | Procedure: Spinal block, Drug: 10 mg of hyperbaric 0.5% bupivacaine10 mg of hyperbaric 0.5% bupivacaine Injection of anesthetic at subarachnoidal space |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Will be included 50 patients, ASA physical status 1 or 2 undergoing hemorrhoidectomy after approval by the Ethics Committee and signed Consent Form
Key exclusion criteria (1 listed)
- There will be excluded patients with associated diseases (fistula, fissure), infection at the puncture site, using anticoagulants or analgesics (up to 2 weeks before the procedure) and pregnant.
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 |
|---|---|---|
| InfiltrationAlso: Local Infiltrationinjection of local anesthetic, associated with general anesthesia | Procedure or surgery | Infiltration, analgesic effect |
| Spinal blockAlso: subarachnoidal blockinjection of anesthetic | Procedure or surgery | Spinal block |
| BupivacaineAlso: Local infiltration10ml 0.5% bupivacaine. | Drug | Infiltration, analgesic effect |
| 10 mg of hyperbaric 0.5% bupivacaineAlso: spinal anesthesiaSpinal punction and injection of local anesthetic | Drug | Spinal block |
Primary outcome
Pain intensity
Time frame: 24 hours
Numerical score
1 secondary outcome
Time to discharge
Time frame: 24 hours
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 3 Feb 2016.
- Individual participant dataSharing planned: No
Related trials for Hemorrhoid
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Ultrasound-Guided Versus Landmark-Guided Pudendal Block for Post-Hemorrhoidectomy Pain
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Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment
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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.
Rioko K Sakata, PhD principal investigator
Universidade Federal de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infiltration, Spinal block and Bupivacaine in people with Hemorrhoid, run by Federal University of São Paulo at 1 site in Brazil.
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 3 Feb 2016. 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 Brazil. 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. 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 intensity (time frame: 24 hours). 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 3 Feb 2016.