Subarachnoid or Infiltration for Hemorrhoidectomy

Not Applicable

Completed

• Conditions: Hemorrhoid
• Interventions: Procedure: Infiltration; Procedure: Spinal block; Drug: 10 mg of hyperbaric 0.5% bupivacaine; Drug: Bupivacaine

• Registration Number: NCT01927874
• Lead Sponsor: Federal University of São Paulo

Brief 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.

Study Timeline

• Study First Submitted: 2012-08-23
• Study Start: 2013-01
• Study First Submitted QC: 2013-08-22
• Study First Posted: 2013-08-23
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-02
• Last Update Posted: 2016-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infiltration, analgesic effect	Infiltration	10ml 0.5% bupivacaine each side Block Injection of local anesthetic at pudendal nerve
Spinal block	Spinal block	10 mg of hyperbaric 0.5% bupivacaine Injection of anesthetic at subarachnoidal space
Spinal block	10 mg of hyperbaric 0.5% bupivacaine	10 mg of hyperbaric 0.5% bupivacaine Injection of anesthetic at subarachnoidal space
Infiltration, analgesic effect	Bupivacaine	10ml 0.5% bupivacaine each side Block Injection of local anesthetic at pudendal nerve

Primary Outcome Measures

Name	Time	Method
Pain intensity	24 hours	Numerical score

Secondary Outcome Measures

Name	Time	Method
Time to discharge	24 hours

Trial Locations

Locations (1)

Universidade Federal de São Paulo; 🇧🇷 São Paulo, Brazil