- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00925912
A Trial of Closed Hemorrhoidectomy Under Local Perianal Block Versus Spinal Anesthesia
A Randomized Clinical Trial of Closed Hemorrhoidectomy Under Local Perianal Block Versus Spinal Anesthesia
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged between 18 and 60 years with grade 3 or 4 hemorrhoid.
- Had no history of bupivacaine allergy.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
spinal anesthesia: Active Comparator The SA group were received a subarachnoid block with 1.5-2.0 ml of 0.5% bupivacaine. |
0.5% bupivacaine 1.5-2 ml injected to subarachnoidal space
Other Names:
|
Experimental: 2
Perianal block with 0.25% bupivacaine
|
0.25% bupivacaine injected at perianal region
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The degree of pain measured by visual analogue scale at 6 and 24 hrs after surgery.
Time Frame: within 24 hrs
|
within 24 hrs
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patients' satisfaction with the anesthetic techniques, postoperative voiding complications, and other complications
Time Frame: within 24 hrs
|
within 24 hrs
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sahaphol Anannamcharoen, M.D.,M.Sc., Phramongkutklao College of Medicine and Hospital
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- s023h/49
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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