NCT01927874

Subarachnoid or Infiltration for Hemorrhoidectomy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Hemorrhoid

Interventions

Type	Name	Description
PROCEDURE	Infiltration	injection of local anesthetic, associated with general anesthesia
PROCEDURE	Spinal block	injection of anesthetic
DRUG	Bupivacaine	10ml 0.5% bupivacaine.
DRUG	10 mg of hyperbaric 0.5% bupivacaine	Spinal punction and injection of local anesthetic

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2013-08-23
• Last updated: 2016-02-03

Locations

1 site across 1 country: Brazil