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

This study has been completed.
Sponsor:
Information provided by:
Phramongkutklao College of Medicine and Hospital
ClinicalTrials.gov Identifier:
NCT00925912
First received: June 18, 2009
Last updated: June 19, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention
Postoperative Pain
Complications
Satisfaction
Procedure: spinal block
Procedure: Perianal block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Closed Hemorrhoidectomy Under Local Perianal Block Versus Spinal Anesthesia

Resource links provided by NLM:


Further study details as provided by Phramongkutklao College of Medicine and Hospital:

Primary Outcome Measures:
  • The degree of pain measured by visual analogue scale at 6 and 24 hrs after surgery. [ Time Frame: within 24 hrs ]

Secondary Outcome Measures:
  • Patients' satisfaction with the anesthetic techniques, postoperative voiding complications, and other complications [ Time Frame: within 24 hrs ]

Enrollment: 64
Study Start Date: December 2006
Study Completion Date: November 2007
Arms Assigned Interventions
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.

Procedure: spinal block
0.5% bupivacaine 1.5-2 ml injected to subarachnoidal space
Other Name: marcaine 0.5%
Experimental: 2
Perianal block with 0.25% bupivacaine
Procedure: Perianal block
0.25% bupivacaine injected at perianal region
Other Name: Marcaine 0.25%

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00925912

Sponsors and Collaborators
Phramongkutklao College of Medicine and Hospital
Investigators
Principal Investigator: Sahaphol Anannamcharoen, M.D.,M.Sc. Phramongkutklao College of Medicine and Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00925912     History of Changes
Other Study ID Numbers: s023h/49
Study First Received: June 18, 2009
Last Updated: June 19, 2009
Health Authority: Thailand: Ethical Committee

Keywords provided by Phramongkutklao College of Medicine and Hospital:
Hemorrhoidectomy
perianal block
local anesthesia
spinal anesthesia

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics
Bupivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014