Subarachnoid or Infiltration for Hemorrhoidectomy

Study Overview
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Brief Summary
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There will be compared the postoperative analgesic effect of infiltration or spinal block for hemorrhoidectomy

Detailed Description
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This is a prospective, randomized study, including 40 patients between 18 and 60 years, of both genders, ASA 1 or 2. Patients in group 1 (n = 20) will be submitted to spinal block and group 2 (n = 20) to infiltration. The spinal block will be performed with 10 mg of 0.5% bupivacaine. The infiltration will be performed with 10 ml of 0.5% bupivacaine with epinephrine on each side. Will be evaluated: intensity of pain on a numerical scale from 0 to 10 every 15 minutes, relaxation of the sphincter muscles, intensity of pain after the operation every 30 minutes until reached the criteria for discharge, muscle strength of the lower limbs every 30 minutes, BP, HR, SO2, FR, other items that determine the conditions of discharge (urine output, nausea and vomiting), time to hospital discharge, and duration of analgesia. Adverse effects and complications will be noted.

Official Title
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Comparative Study of the Analgesic Effect of Subarachnoid or Infiltration for Hemorrhoidectomy

Conditions
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Hemorrhoid

Intervention / Treatment
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* Procedure: Infiltration
* Procedure: Spinal block
* Drug: Bupivacaine
* Drug: 10 mg of hyperbaric 0.5% bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Will be included 50 patients, ASA physical status 1 or 2 undergoing hemorrhoidectomy after approval by the Ethics Committee and signed Consent Form Exclusion Criteria: There will be excluded patients with associated diseases (fistula, fissure), infection at the puncture site, using anticoagulants or analgesics (up to 2 weeks before the procedure) and pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Infiltration, analgesic effect<br>10ml 0.5% bupivacaine each side Block Injection of local anesthetic at pudendal nerve | Procedure: Infiltration<br>* injection of local anesthetic, associated with general anesthesia<br>* Other names: Local Infiltration;Drug: Bupivacaine<br>* 10ml 0.5% bupivacaine.<br>* Other names: Local infiltration;|
| Active Comparator: Spinal block<br>10 mg of hyperbaric 0.5% bupivacaine Injection of anesthetic at subarachnoidal space | Procedure: Spinal block<br>* injection of anesthetic<br>* Other names: subarachnoidal block;Drug: 10 mg of hyperbaric 0.5% bupivacaine<br>* Spinal punction and injection of local anesthetic<br>* Other names: spinal anesthesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Numerical score | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to discharge |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infiltration, hemorrhoidectomy, Postoperative pain