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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00925912
• Other study ID #: s023h/49
• Status: Completed
• Phase: N/A
• First received: June 18, 2009
• Last updated: June 19, 2009
• Start date: December 2006
• Est. completion date: November 2007

Study information

• Verified date: June 2009
• Source: Phramongkutklao College of Medicine and Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complications
• Pain, Postoperative
• Postoperative Pain
• Satisfaction

Intervention

Procedure:
• spinal block
0.5% bupivacaine 1.5-2 ml injected to subarachnoidal space
• Perianal block
0.25% bupivacaine injected at perianal region

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Phramongkutklao College of Medicine and Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The degree of pain measured by visual analogue scale at 6 and 24 hrs after surgery.		within 24 hrs
Secondary	Patients' satisfaction with the anesthetic techniques, postoperative voiding complications, and other complications		within 24 hrs