Postoperative PainNCT00925912
A Trial of Closed Hemorrhoidectomy Under Local Perianal Block Versus Spinal Anesthesia
A study testing spinal block and Perianal block in people with Postoperative Pain and Complications, run by Phramongkutklao College of Medicine and Hospital.
Trial summary
Hemorrhoidectomy can be carried out under several modes of anesthesia. In western country hemorrhoidectomy usually be performed under general anesthesia, however there may be the complications resulted from general anesthesia together with associated diseases in advanced age, caudal or spinal anesthesia has been used… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Complications, Satisfaction
- What is being tested?
- spinal block and Perianal block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Nov 2007
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged between 18 and 60 years with grade 3 or 4 hemorrhoid.
- Had no history of bupivacaine allergy.
Who cannot join
- Complicated hemorrhoid e.g. prolapsed or incarcerated hemorrhoid, gangrenous hemorrhoid.
- Associated anorectal disease.
- Patients whose characteristics of his/her buttock were difficult to gained adequate exposure when performing surgery under local anesthesia such as the mounds of his/her buttock is very high and rise almost straight up from the anal verge.
- Patient was unfit for surgery e.g. heart disease, liver cirrhosis, or coagulopathy.
- Patients who had symptoms of benign prostatic hypertrophy or bladder neck obstruction.
- Pregnancy.
- Patients with neuropsychotic problems.
- Did not agree to participate this study
About this study
Official title: A Randomized Clinical Trial of Closed Hemorrhoidectomy Under Local Perianal Block Versus Spinal Anesthesia
Hemorrhoidectomy can be carried out under several modes of anesthesia. In western country hemorrhoidectomy usually be performed under general anesthesia, however there may be the complications resulted from general anesthesia together with associated diseases in advanced age, caudal or spinal anesthesia has been used as an alternative to general anesthesia (GA) for hemorrhoid surgery but they all require a trained anesthetist and have numerous known complications. Since, anesthesiologists are not always available then local anesthesia is an alternative mode of anesthesia that surgeon can safely carry out by their own. Local anesthetic produce a loss of sensation and muscle paralysis in a circumscribed area of body by localized effect on peripheral nerve endings. The local anesthesia is able to provide fully relaxation of the anal canal which is an ideal setting for various anal surgical procedures. The results of hemorrhoid surgery under this mode of anesthesia have been demonstrated in many publications. Local anesthesia is a safe and effective technique while fewer risks and complications compared with general or spinal anesthesia. In Thailand both spinal anesthesia and local perianal block have routinely been used for various kinds of anorectal surgery. However, so far there has no any trial conducting to compare between these two techniques.
Read the detailed description
Objectives: To study analgesic efficacy, postoperative voiding problems, patients' satisfaction, and other complications after closed hemorrhoidectomy comparison between local perianal block and spinal anesthesia.
Research design: Randomized controlled trial Setting: Phramongkutklao Hospital Research methodology: A total of 64 subjects (32 males and 32 females) underwent elective hemorrhoidectomy were randomly allocated into two groups. Thirty-two patients were randomly allocated to receive spinal anesthesia (SA group) while 32 patients received local perianal block (LA group). Duration of analgesic effect, pain measurement with visual analogue scale (VAS) at 6 and 24 hours, quantity of analgesic medication administered, postoperative complication, and patient's satisfaction with the anesthetic technique were recorded.
- Conditions
- Postoperative Pain, Complications, Satisfaction
- Being tested
- spinal block, Perianal block
- Keywords
- Hemorrhoidectomy, perianal block, local anesthesia, spinal anesthesia
- Medical subject headings
- Pain, Postoperative, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal blockProcedure or surgery
Also called marcaine 0.5%
0.5% bupivacaine 1.5-2 ml injected to subarachnoidal space
Perianal blockProcedure or surgery
Also called Marcaine 0.25%
0.25% bupivacaine injected at perianal region
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | spinal anesthesia: Active Comparator
The SA group were received a subarachnoid block with 1.5-2.0 ml of 0.5% bupivacaine. Receives: Procedure: spinal block |
| 2 | Experimental | Perianal block with 0.25% bupivacaine Receives: Procedure: Perianal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of pain measured by visual analogue scale at 6 and 24 hrs after surgery.
Measured: within 24 hrs
Secondary outcomes (1)
Patients' satisfaction with the anesthetic techniques, postoperative voiding complications, and other complications
Measured: within 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startDec 2006
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phramongkutklao College of Medicine and Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Sahaphol Anannamcharoen, M.D.,M.Sc., Principal investigator, Phramongkutklao College of Medicine and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925912
- Sponsor's protocol ID
- s023h/49
- Status last verified
- Jun 2009
- First submitted
- 18 Jun 2009
- Last updated
- 22 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Closed Hemorrhoidectomy Under Local Perianal Block Versus Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT00925912
- Acronym / sponsor ID
- s023h/49
- Conditions
- Postoperative Pain, Complications, Satisfaction
- Keywords
- Hemorrhoidectomy, perianal block, local anesthesia, spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Phramongkutklao College of Medicine and HospitalUniversity, hospital or other
- Study start
- Dec 2006
- Study completion
- Nov 2007 (actual)
- First posted
- 22 Jun 2009 (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.
Hemorrhoidectomy can be carried out under several modes of anesthesia. In western country hemorrhoidectomy usually be performed under general anesthesia, however there may be the complications resulted from general anesthesia together with associated diseases in advanced age, caudal or spinal anesthesia has been used as an alternative to general anesthesia (GA) for hemorrhoid surgery but they all require a trained anesthetist and have numerous known complications. Since, anesthesiologists are not always available then local anesthesia is an alternative mode of anesthesia that surgeon can safely carry out by their own. Local anesthetic produce a loss of sensation and muscle paralysis in a circumscribed area of body by localized effect on peripheral nerve endings. The local anesthesia is able to provide fully relaxation of the anal canal which is an ideal setting for various anal surgical procedures. The results of hemorrhoid surgery under this mode of anesthesia have been demonstrated in many publications. Local anesthesia is a safe and effective technique while fewer risks and complications compared with general or spinal anesthesia. In Thailand both spinal anesthesia and local perianal block have routinely been used for various kinds of anorectal surgery. However, so far there has no any trial conducting to compare between these two techniques.
Detailed description
Objectives: To study analgesic efficacy, postoperative voiding problems, patients' satisfaction, and other complications after closed hemorrhoidectomy comparison between local perianal block and spinal anesthesia.
Research design: Randomized controlled trial Setting: Phramongkutklao Hospital Research methodology: A total of 64 subjects (32 males and 32 females) underwent elective hemorrhoidectomy were randomly allocated into two groups. Thirty-two patients were randomly allocated to receive spinal anesthesia (SA group) while 32 patients received local perianal block (LA group). Duration of analgesic effect, pain measurement with visual analogue scale (VAS) at 6 and 24 hours, quantity of analgesic medication administered, postoperative complication, and patient's satisfaction with the anesthetic technique were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: spinal blockspinal anesthesia: Active Comparator The SA group were received a subarachnoid block with 1.5-2.0 ml of 0.5% bupivacaine. |
| 2 | Experimental | Procedure: Perianal blockPerianal block with 0.25% bupivacaine |
Who may qualify
- Ages
- 18 to 60 years
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients aged between 18 and 60 years with grade 3 or 4 hemorrhoid.
- Had no history of bupivacaine allergy.
Key exclusion criteria (8 listed)
- Complicated hemorrhoid e.g. prolapsed or incarcerated hemorrhoid, gangrenous hemorrhoid.
- Associated anorectal disease.
- Patients whose characteristics of his/her buttock were difficult to gained adequate exposure when performing surgery under local anesthesia such as the mounds of his/her buttock is very high and rise almost straight up from the anal verge.
- Patient was unfit for surgery e.g. heart disease, liver cirrhosis, or coagulopathy.
- Patients who had symptoms of benign prostatic hypertrophy or bladder neck obstruction.
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 |
|---|---|---|
| spinal blockAlso: marcaine 0.5%0.5% bupivacaine 1.5-2 ml injected to subarachnoidal space | Procedure or surgery | 1 |
| Perianal blockAlso: Marcaine 0.25%0.25% bupivacaine injected at perianal region | Procedure or surgery | 2 |
Primary outcome
The degree of pain measured by visual analogue scale at 6 and 24 hrs after surgery.
Time frame: within 24 hrs
1 secondary outcome
Patients' satisfaction with the anesthetic techniques, postoperative voiding complications, and other complications
Time frame: within 24 hrs
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 22 Jun 2009.
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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.
Sahaphol Anannamcharoen, M.D.,M.Sc. principal investigator
Phramongkutklao College of Medicine and Hospital
Questions about this trial
What is this clinical trial studying?
A study testing spinal block and Perianal block in people with Postoperative Pain and Complications, run by Phramongkutklao College of Medicine and Hospital.
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 8 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 22 Jun 2009. 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?
The degree of pain measured by visual analogue scale at 6 and 24 hrs after surgery. (time frame: within 24 hrs). 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 22 Jun 2009.