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NCT Number: NCT02839538

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

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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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

local infiltration

Procedure

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

Other names: local anesthesia

Subarachnoidal block

Procedure

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

Other names: spinal anesthesia

Primary outcomes

  1. Pain intensity

    Time frame: 24 hours

    Numerical score

Secondary outcomes

  1. Time to discharge

    Time frame: 24 hours

Other outcomes

  1. Duration of motor blockade

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

A Comparative Randomised Study of the Analgesic Effect of Local Infiltration or Spinal Block for Haemorrhoidectomy

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 21, 2016
Registry last updated
Jul 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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