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

NCT ID: NCT00925912

Last Updated: 2009-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2007-11-30

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.

Conditions

Postoperative Pain; Complications; Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

spinal anesthesia: Active Comparator

The SA group were received a subarachnoid block with 1.5-2.0 ml of 0.5% bupivacaine.

Group Type: ACTIVE_COMPARATOR

spinal block

Intervention Type: PROCEDURE

0.5% bupivacaine 1.5-2 ml injected to subarachnoidal space

2

Perianal block with 0.25% bupivacaine

Group Type: EXPERIMENTAL

Perianal block

Intervention Type: PROCEDURE

0.25% bupivacaine injected at perianal region

Interventions

spinal block

0.5% bupivacaine 1.5-2 ml injected to subarachnoidal space

Intervention Type: PROCEDURE

Perianal block

0.25% bupivacaine injected at perianal region

Intervention Type: PROCEDURE

Other Intervention Names

marcaine 0.5%; Marcaine 0.25%

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Accepts Healthy Volunteers: Yes

Sponsors

Phramongkutklao College of Medicine and Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Sahaphol Anannamcharoen, M.D.,M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Phramongkutklao College of Medicine and Hospital

Other Identifiers

s023h/49

Identifier Type: -

Identifier Source: org_study_id