A Trial of Closed Hemorrhoidectomy Under Local Perianal Block Versus Spinal Anesthesia
Primary Purpose
Postoperative Pain, Complications, Satisfaction
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
spinal block
Perianal block
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Hemorrhoidectomy, perianal block, local anesthesia, spinal anesthesia
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
spinal anesthesia: Active Comparator The SA group were received a subarachnoid block with 1.5-2.0 ml of 0.5% bupivacaine.
Perianal block with 0.25% bupivacaine
Outcomes
Primary Outcome Measures
The degree of pain measured by visual analogue scale at 6 and 24 hrs after surgery.
Secondary Outcome Measures
Patients' satisfaction with the anesthetic techniques, postoperative voiding complications, and other complications
Full Information
NCT ID
NCT00925912
First Posted
June 18, 2009
Last Updated
June 19, 2009
Sponsor
Phramongkutklao College of Medicine and Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00925912
Brief Title
A Trial of Closed Hemorrhoidectomy Under Local Perianal Block Versus Spinal Anesthesia
Official Title
A Randomized Clinical Trial of Closed Hemorrhoidectomy Under Local Perianal Block Versus Spinal Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Phramongkutklao College of Medicine and Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Complications, Satisfaction
Keywords
Hemorrhoidectomy, perianal block, local anesthesia, spinal anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
spinal anesthesia: Active Comparator
The SA group were received a subarachnoid block with 1.5-2.0 ml of 0.5% bupivacaine.
Arm Title
2
Arm Type
Experimental
Arm Description
Perianal block with 0.25% bupivacaine
Intervention Type
Procedure
Intervention Name(s)
spinal block
Other Intervention Name(s)
marcaine 0.5%
Intervention Description
0.5% bupivacaine 1.5-2 ml injected to subarachnoidal space
Intervention Type
Procedure
Intervention Name(s)
Perianal block
Other Intervention Name(s)
Marcaine 0.25%
Intervention Description
0.25% bupivacaine injected at perianal region
Primary Outcome Measure Information:
Title
The degree of pain measured by visual analogue scale at 6 and 24 hrs after surgery.
Time Frame
within 24 hrs
Secondary Outcome Measure Information:
Title
Patients' satisfaction with the anesthetic techniques, postoperative voiding complications, and other complications
Time Frame
within 24 hrs
10. Eligibility
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahaphol Anannamcharoen, M.D.,M.Sc.
Organizational Affiliation
Phramongkutklao College of Medicine and Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Trial of Closed Hemorrhoidectomy Under Local Perianal Block Versus Spinal Anesthesia
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