Subarachnoid or Infiltration for Hemorrhoidectomy
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|ClinicalTrials.gov Identifier: NCT01927874|
Recruitment Status : Completed
First Posted : August 23, 2013
Last Update Posted : February 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhoid||Procedure: Infiltration Procedure: Spinal block Drug: Bupivacaine Drug: 10 mg of hyperbaric 0.5% bupivacaine||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Study of the Analgesic Effect of Subarachnoid or Infiltration for Hemorrhoidectomy|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Active Comparator: Infiltration, analgesic effect
10ml 0.5% bupivacaine each side Block Injection of local anesthetic at pudendal nerve
injection of local anesthetic, associated with general anesthesia
Other Name: Local Infiltration
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
- Pain intensity [ Time Frame: 24 hours ]Numerical score
- Time to discharge [ Time Frame: 24 hours ]
- Duration of motor blockade [ Time Frame: 24 hours ]
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
|Universidade Federal de São Paulo|
|São Paulo, Brazil, 04044020|
|Principal Investigator:||Rioko K Sakata, PhD||Universidade Federal de São Paulo|