Comparative Study of the Analgesic Effect of Spinal Anesthesia or Infiltration Anesthesia for Hemorrhoidectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-11-30

Brief Summary

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Background and Objectives: Postoperative analgesia and early recovery are relevant for hospital discharge after hemorrhoidectomy. This study investigated the postoperative analgesic effect with local infiltration compared with spinal block.

Methods: This randomized study included 40 patients aged 18 to 60 years old. Local group (LG) received local infiltration under general anaesthesia; spinal group (SG) received a subarachnoid block. LG received general anaesthesia with propofol, atracurium and propofol infusion as well as a local infiltration of 20 ml 0.75% ropivacaine. SG received 2 ml of 0.5% hyperbaric bupivacaine. Analgesic supplementation was with 50µg of fentanyl for LG and 1% lidocaine for SG. There were assessed: postoperative pain intensity, sphincter relaxation, motor blockade of lower limbs, time to discharge, analgesic dose over 1 week and adverse effects.

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Detailed Description

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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= 19 ) will be submitted to spinal block and group 2 (n=21) to local infiltration. The spinal block will be performed with 10 mg of 0.5% bupivacaine. The infiltration will be performed with 10 ml of 0.75% ropivacaine on each side.

Will be evaluated: intensity of pain on a numerical scale from 0 to 10 every 30 minutes, relaxation of the sphincter muscles, intensity of pain after the operation every 30 minutes until reached the criteria for discharge, motor blocked 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

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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local Infiltration

Induction of General Anesthesia with Propofol(2mg/Kg) and Atracurium(0,5mg/Kg) . Pulmonary ventilation with laryngeal mask and Propofol infusion ( 100mcg/Kg/min.) After , Infiltration of 0.75% ropivacaine (10 ml) each side block injection of local anesthetic at perianal.

If necessary, fentanyl endovenous injection (50 mcg).

Group Type ACTIVE_COMPARATOR

Local Infiltration

Intervention Type PROCEDURE

Injection at perianal region with ropivacaine 0.75%(20ml)

Subarachnoidal block

Sedation with midazolam 2 mg. After , Spinal block with 10 mg of hyperbaric 0.5% bupivacaine. Injection of anesthetic at subarachnoidal space with Quincke needle 27G.

If pain, local infiltration with lidocaine 1% (5 ml) in wound.

Group Type OTHER

Subarachnoidal block

Intervention Type PROCEDURE

Injection at subarachnoidal space with bupivacaine 0.5% ( 2ml)

Interventions

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Local Infiltration

Injection at perianal region with ropivacaine 0.75%(20ml)

Intervention Type PROCEDURE

Subarachnoidal block

Injection at subarachnoidal space with bupivacaine 0.5% ( 2ml)

Intervention Type PROCEDURE

Other Intervention Names

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local anesthesia spinal anesthesia

Eligibility Criteria

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Inclusion Criteria

* Will be included 40 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes