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Subarachnoid or Infiltration for Hemorrhoidectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Federal University of São Paulo
Sponsor:
Information provided by (Responsible Party):
Rioko Kimiko Sakata, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01927874
First received: August 23, 2012
Last updated: February 24, 2014
Last verified: February 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Federal University of São Paulo:

Primary Outcome Measures:
  • Pain intensity [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Numerical score


Secondary Outcome Measures:
  • Time to discharge [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Duration of motor blockade [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: September 2014 (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
Other Name: Local Infiltration
Drug: Bupivacaine
10ml 0.5% bupivacaine. Injection of local anesthetic around the nerve
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

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01927874

Contacts
Contact: Rioko K Sakata, PhD 055 11 50847463 riokoks.dcir@epm.br

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

No publications provided

Responsible Party: Rioko Kimiko Sakata, PhD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01927874     History of Changes
Other Study ID Numbers: Bl.Pud
Study First Received: August 23, 2012
Last Updated: February 24, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
Pudendal block
hemorrhoidectomy
Postoperative pain

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

ClinicalTrials.gov processed this record on July 29, 2014