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Subarachnoid or Infiltration for Hemorrhoidectomy

This study has been completed.
Information provided by (Responsible Party):
Rioko Kimiko Sakata, Federal University of São Paulo Identifier:
First received: August 23, 2012
Last updated: February 2, 2016
Last verified: February 2016
There will be compared the postoperative analgesic effect of infiltration or spinal block for hemorrhoidectomy

Condition Intervention
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: 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 ]
    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.


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

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.
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Please refer to this study by its identifier: NCT01927874

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

Responsible Party: Rioko Kimiko Sakata, PhD, Federal University of São Paulo Identifier: NCT01927874     History of Changes
Other Study ID Numbers: Bl.Pud
Study First Received: August 23, 2012
Last Updated: February 2, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Federal University of São Paulo:
Postoperative pain

Additional relevant MeSH terms:
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on May 23, 2017