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Subarachnoid or Infiltration for Hemorrhoidectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01927874
First Posted: August 23, 2013
Last Update Posted: February 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rioko Kimiko Sakata, Federal University of São Paulo
  Purpose
There will be compared the postoperative analgesic effect of infiltration or spinal block for hemorrhoidectomy

Condition Intervention
Hemorrhoid Procedure: Infiltration Procedure: Spinal block Drug: Bupivacaine Drug: 10 mg of hyperbaric 0.5% bupivacaine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study of the Analgesic Effect of Subarachnoid or Infiltration for Hemorrhoidectomy

Resource links provided by NLM:


Further study details as provided by Rioko Kimiko Sakata, Federal University of São Paulo:

Primary Outcome Measures:
  • Pain intensity [ Time Frame: 24 hours ]
    Numerical score


Secondary Outcome Measures:
  • Time to discharge [ Time Frame: 24 hours ]

Other Outcome Measures:
  • Duration of motor blockade [ Time Frame: 24 hours ]

Enrollment: 40
Study Start Date: January 2013
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Infiltration, analgesic effect
10ml 0.5% bupivacaine each side Block Injection of local anesthetic at pudendal nerve
Procedure: Infiltration
injection of local anesthetic, associated with general anesthesia
Other Name: Local Infiltration
Drug: Bupivacaine
10ml 0.5% bupivacaine.
Other Name: Local infiltration
Active Comparator: Spinal block
10 mg of hyperbaric 0.5% bupivacaine Injection of anesthetic at subarachnoidal space
Procedure: Spinal block
injection of anesthetic
Other Name: subarachnoidal block
Drug: 10 mg of hyperbaric 0.5% bupivacaine
Spinal punction and injection of local anesthetic
Other Name: spinal anesthesia

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01927874


Locations
Brazil
Universidade Federal de São Paulo
São Paulo, Brazil, 04044020
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Rioko K Sakata, PhD Universidade Federal de São Paulo
  More Information

Responsible Party: Rioko Kimiko Sakata, PhD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01927874     History of Changes
Other Study ID Numbers: Bl.Pud
First Submitted: August 23, 2012
First Posted: August 23, 2013
Last Update Posted: February 3, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rioko Kimiko Sakata, Federal University of São Paulo:
infiltration
hemorrhoidectomy
Postoperative pain

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Analgesics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents