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

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.

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Key information

Conditions

Postoperative Pain Behavior Complications Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction Postoperative Complications Satisfaction Signs and Symptoms

Age range

18 year–60 year

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

spinal block

Procedure

0.5% bupivacaine 1.5-2 ml injected to subarachnoidal space

Other names: marcaine 0.5%

Perianal block

Procedure

0.25% bupivacaine injected at perianal region

Other names: Marcaine 0.25%

Primary outcomes

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

Time frame: within 24 hrs

Secondary outcomes

Patients' satisfaction with the anesthetic techniques, postoperative voiding complications, and other complications

Time frame: within 24 hrs

Sponsors and collaborators

Lead sponsor

Phramongkutklao College of Medicine and Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2006
Study completion: 2007
First posted: Jun 22, 2009
Registry last updated: Jun 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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