Subarachnoid or Infiltration for Hemorrhoidectomy

Federal University of São Paulo

Status: Completed

Conditions: Hemorrhoid

Treatments: Procedure: Spinal block; Drug: Bupivacaine; Procedure: Infiltration; Drug: 10 mg of hyperbaric 0.5% bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01927874

Bl.Pud

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Infiltration, analgesic effect

Active Comparator group

Description:

10ml 0.5% bupivacaine each side Block Injection of local anesthetic at pudendal nerve

Treatment:

Procedure: Infiltration

Drug: Bupivacaine

Spinal block

Active Comparator group

Description:

10 mg of hyperbaric 0.5% bupivacaine Injection of anesthetic at subarachnoidal space

Treatment:

Drug: 10 mg of hyperbaric 0.5% bupivacaine

Procedure: Spinal block