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

Sponsor

Phramongkutklao College of Medicine and Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00925912

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Complications Satisfaction	Procedure: spinal block Procedure: Perianal block	N/A

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

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2006

Actual Study Completion Date :

Nov 1, 2007

Arms and Interventions

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

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.

Procedure: spinal block

0.5% bupivacaine 1.5-2 ml injected to subarachnoidal space

Other Names:

marcaine 0.5%

Experimental: 2

Perianal block with 0.25% bupivacaine

Procedure: Perianal block

0.25% bupivacaine injected at perianal region

Other Names:

Marcaine 0.25%

Outcome Measures

Primary Outcome Measures

The degree of pain measured by visual analogue scale at 6 and 24 hrs after surgery. [within 24 hrs]

Secondary Outcome Measures

Patients' satisfaction with the anesthetic techniques, postoperative voiding complications, and other complications [within 24 hrs]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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