An interventional study of Ultrasound Guided Caudal Block in Anal Fissure, Anal Fistula and Hemorrhoids, sponsored by Universidad de Antioquia. Completed at 1 site in Colombia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-04-30.
Sponsored by Universidad de Antioquia · Not applicable, Interventional, and Treatment
Interventional study that evaluate analgesia and side effects of Ultrasound guided Caudal block preoperatively in benign canal anal surgery
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.
Objective:
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.
84 studies on the registry are indexed under Fissure in Ano; 16 are open to participants now.
This study's enrollment of 23 is below the median of 99 across 65 interventional studies indexed under Fissure in Ano.
Browse Fissure in Ano studies →Universidad de Antioquia is the lead sponsor of 80 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
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.
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")
Time frame: 1 day
Rescue Analgesia (R3) need of opioid medication for rescue severe postoperative pain at 6, 12 and 24 hours after surgery.
Doses of intravenous tramadol for rescue in severe postoperative pain
Time frame: 1 day
motor block
presence or absence of motor block in lower extremity after caudal block
Time frame: 2 hours post surgical
Plan to share: No — only final results of research
Ran from Nov 2015 to primary completion in May 2016, 6 months.
Of 25 interventional studies with no phase under Fissure in Ano, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's 6 months is below that.
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This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Universidad de Antioquia