Skip to main content
OpenTrials
Completed

NCT Number: NCT01927874

Subarachnoid or Infiltration for Hemorrhoidectomy

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hemorrhoid Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Hemorrhoids Intestinal Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases Signs and Symptoms Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de São Paulo

São Paulo, 04044020, Brazil

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 = 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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Infiltration

Procedure

injection of local anesthetic, associated with general anesthesia

Other names: Local Infiltration

spinal block

Procedure

injection of anesthetic

Other names: subarachnoidal block

Bupivacaine

Drug

10ml 0.5% bupivacaine.

Other names: Local infiltration

10 mg of hyperbaric 0.5% bupivacaine

Drug

Spinal punction and injection of local anesthetic

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

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 23, 2013
Registry last updated
Feb 3, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.