Subarachnoid or Infiltration for Hemorrhoidectomy

Hemorrhoid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01927874
• Other study ID #: Bl.Pud
• Status: Completed
• Phase: N/A
• First received: August 23, 2012
• Last updated: February 2, 2016
• Start date: January 2013
• Est. completion date: November 2015

Study information

• Verified date: February 2016
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Hemorrhoid
• Hemorrhoids

Intervention

Procedure:
• Infiltration
injection of local anesthetic, associated with general anesthesia
• Spinal block
injection of anesthetic

Drug:
• Bupivacaine
10ml 0.5% bupivacaine.
• 10 mg of hyperbaric 0.5% bupivacaine
Spinal punction and injection of local anesthetic

Locations

Country	Name	City	State
Brazil	Universidade Federal de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of motor blockade		24 hours	Yes
Primary	Pain intensity	Numerical score	24 hours	No
Secondary	Time to discharge		24 hours	Yes