Subarachnoid or Infiltration for Hemorrhoidectomy
|Hemorrhoid||Procedure: Infiltration Procedure: Spinal block Drug: Bupivacaine Drug: 10 mg of hyperbaric 0.5% bupivacaine|
|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|
- Pain intensity [ Time Frame: 24 hours ]Numerical score
- Time to discharge [ Time Frame: 24 hours ]
- Duration of motor blockade [ Time Frame: 24 hours ]
|Study Start Date:||January 2013|
|Study Completion Date:||November 2015|
|Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
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 InfiltrationDrug: 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 blockDrug: 10 mg of hyperbaric 0.5% bupivacaine
Spinal punction and injection of local anesthetic
Other Name: spinal anesthesia
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01927874
|Universidade Federal de São Paulo|
|São Paulo, Brazil, 04044020|
|Principal Investigator:||Rioko K Sakata, PhD||Universidade Federal de São Paulo|