Ultrasound Guided Caudal Block for Benign Anal Surgery
|ClinicalTrials.gov Identifier: NCT03345511|
Recruitment Status : Completed
First Posted : November 17, 2017
Last Update Posted : April 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Anal Fissure Anal Fistula Hemorrhoids Pain, Postoperative||Procedure: Ultrasound Guided Caudal Block||Not Applicable|
Postoperative pain is an important symptom in patients after benign anal canal surgery. Caudal block has been described to decrease postoperative pain in this type of surgery. Ultrasound is a tool that facilitates its performance and increases the rate of a successful block.
To determine the usefulness of ultrasound guided caudal block in anesthesia and postoperative analgesia in patients scheduled for benign anal surgery. Methods : Interventional study in adult patients that received ultrasound caudal anesthetic block before benign anal surgery. The investigators evaluated analgesic efficacy of this intervention by mean of numeric rating scale ( NRS) for pain after 6, 12 and 24 hours of surgery, rescue analgesia, motor block, urinary retention, surgical conditions and patient satisfaction in postoperative period.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||interventional|
|Masking:||None (Open Label)|
|Official Title:||Ultrasound Guided Analgesic Caudal Block in Anal Canal Surgery|
|Actual Study Start Date :||November 1, 2015|
|Actual Primary Completion Date :||May 30, 2016|
|Actual Study Completion Date :||June 30, 2016|
Experimental: Ultrasound Guided Caudal Block
30 minutes before benign canal anal surgery, a 18 G tuohy needle guided with an ultrasound probe to visualize the caudal space, a solution of bupivacaine 0.25%, Lidocaine 1% and dexamethasone 8mg was injected and needle removed.
Procedure: Ultrasound Guided Caudal Block
Using an external ultrasound probe, the investigators guided a 18 gauge epidural needle into the caudal space and injected a local anesthetic solution consisting in bupivacaine 0.25%, lidocaine 1% and dexamethasone 8mg in the caudal space.
- postoperative pain intensity (P3). Self reported pain intensity at 6, 12 and 24 hours after surgery. [ Time Frame: 1 day ]The pain numeric Rating Scale (NRS) is a single 11-point numeric scale in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain , with 0 representing one pain extreme (e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable")
- Rescue Analgesia (R3) need of opioid medication for rescue severe postoperative pain at 6, 12 and 24 hours after surgery. [ Time Frame: 1 day ]Doses of intravenous tramadol for rescue in severe postoperative pain
- motor block [ Time Frame: 2 hours post surgical ]presence or absence of motor block in lower extremity after caudal block
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03345511
|hospital universitario San Vicente Fundacion|
|Medellin, Antioquia, Colombia|
|Principal Investigator:||Adriana M Cadavid, MD||Anesthesiology Professor|