Subarachnoid or Infiltration for Hemorrhoidectomy

Hemorrhoid Clinical Trial

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

Status Completed

Clinical Trial Summary

There will be compared the postoperative analgesic effect of infiltration or spinal block for hemorrhoidectomy

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhoid
• Hemorrhoids

• NCT number: NCT01927874
• Study type: Interventional
• Source: Federal University of São Paulo
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Completion date: November 2015