Subarachnoid or Infiltration for Hemorrhoidectomy
Primary Purpose
Hemorrhoid
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Infiltration
Spinal block
Bupivacaine
10 mg of hyperbaric 0.5% bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhoid focused on measuring infiltration, hemorrhoidectomy, Postoperative pain
Eligibility 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.
Sites / Locations
- Universidade Federal de São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Infiltration, analgesic effect
Spinal block
Arm Description
10ml 0.5% bupivacaine each side Block Injection of local anesthetic at pudendal nerve
10 mg of hyperbaric 0.5% bupivacaine Injection of anesthetic at subarachnoidal space
Outcomes
Primary Outcome Measures
Pain intensity
Numerical score
Secondary Outcome Measures
Time to discharge
Full Information
NCT ID
NCT01927874
First Posted
August 23, 2012
Last Updated
February 2, 2016
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01927874
Brief Title
Subarachnoid or Infiltration for Hemorrhoidectomy
Official Title
Comparative Study of the Analgesic Effect of Subarachnoid or Infiltration for Hemorrhoidectomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
There will be compared the postoperative analgesic effect of infiltration or spinal block for hemorrhoidectomy
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoid
Keywords
infiltration, hemorrhoidectomy, Postoperative pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Infiltration, analgesic effect
Arm Type
Active Comparator
Arm Description
10ml 0.5% bupivacaine each side Block Injection of local anesthetic at pudendal nerve
Arm Title
Spinal block
Arm Type
Active Comparator
Arm Description
10 mg of hyperbaric 0.5% bupivacaine Injection of anesthetic at subarachnoidal space
Intervention Type
Procedure
Intervention Name(s)
Infiltration
Other Intervention Name(s)
Local Infiltration
Intervention Description
injection of local anesthetic, associated with general anesthesia
Intervention Type
Procedure
Intervention Name(s)
Spinal block
Other Intervention Name(s)
subarachnoidal block
Intervention Description
injection of anesthetic
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Local infiltration
Intervention Description
10ml 0.5% bupivacaine.
Intervention Type
Drug
Intervention Name(s)
10 mg of hyperbaric 0.5% bupivacaine
Other Intervention Name(s)
spinal anesthesia
Intervention Description
Spinal punction and injection of local anesthetic
Primary Outcome Measure Information:
Title
Pain intensity
Description
Numerical score
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Time to discharge
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
Duration of motor blockade
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rioko K Sakata, PhD
Organizational Affiliation
Universidade Federal de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de São Paulo
City
São Paulo
ZIP/Postal Code
04044020
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Subarachnoid or Infiltration for Hemorrhoidectomy
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