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

NCT00925912 | Completed DMC

• 1 other identifier: s023h/49
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Pain; Complications; Satisfaction

Keywords

Hemorrhoidectomy; perianal block; local anesthesia; spinal anesthesia

Outcome Measures

Primary Outcomes (1)

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

  within 24 hrs

Secondary Outcomes (1)

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

  within 24 hrs

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

EXPERIMENTAL

Perianal block with 0.25% bupivacaine

Procedure: Perianal block

Interventions

spinal block PROCEDURE

0.5% bupivacaine 1.5-2 ml injected to subarachnoidal space

Also known as: marcaine 0.5%

1

Perianal block PROCEDURE

0.25% bupivacaine injected at perianal region

Also known as: Marcaine 0.25%

2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged between 18 and 60 years with grade 3 or 4 hemorrhoid.
• Had no history of bupivacaine allergy.

You may not qualify if:

• 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

Sponsors & Collaborators

• Phramongkutklao College of Medicine and Hospital: lead

MeSH Terms

Conditions

Pain, Postoperative; Personal Satisfaction

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Sahaphol Anannamcharoen, M.D.,M.Sc.

  Phramongkutklao College of Medicine and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 18, 2009
• First Posted: June 22, 2009
• Study Start: December 1, 2006
• Study Completion: November 1, 2007
• Last Updated: June 22, 2009

Record last verified: 2009-06