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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
Phramongkutklao College of Medicine and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Hemorrhoidectomy, perianal block, local anesthesia, spinal anesthesia

Eligibility Criteria

18 Years - 60 Years (Adult)Accepts Healthy Volunteers

Inclusion Criteria:

  1. Patients aged between 18 and 60 years with grade 3 or 4 hemorrhoid.
  2. Had no history of bupivacaine allergy.

Exclusion Criteria:

  1. Complicated hemorrhoid e.g. prolapsed or incarcerated hemorrhoid, gangrenous hemorrhoid.
  2. Associated anorectal disease.
  3. 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.
  4. Patient was unfit for surgery e.g. heart disease, liver cirrhosis, or coagulopathy.
  5. Patients who had symptoms of benign prostatic hypertrophy or bladder neck obstruction.
  6. Pregnancy.
  7. Patients with neuropsychotic problems.
  8. 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

    First Posted
    June 18, 2009
    Last Updated
    June 19, 2009
    Sponsor
    Phramongkutklao College of Medicine and Hospital
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    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

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    A Trial of Closed Hemorrhoidectomy Under Local Perianal Block Versus Spinal Anesthesia

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