Clinical trial NCT03345511: Ultrasound Guided Caudal Block for Benign Anal Surgery
Official title: Ultrasound Guided Analgesic Caudal Block in Anal Canal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anal Fissure
Anal Fistula
Hemorrhoids
Pain, Postoperative
Keywords: ultrasound guided caudal block
anal surgery
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: interventional
Primary purpose: TREATMENT

Brief summary: Interventional study that evaluate analgesia and side effects of Ultrasound guided Caudal block preoperatively in benign canal anal surgery

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* age from 18 to 70 year old patient
* schedule for benign anal surgery ( hemorrhoids, anal fistula, fissure or abcess )
* Caudal analgesic injection before surgery
* Use of ultrasound to guide needle insertion into caudal space

Exclusion Criteria:

* cognitive impairment
* verbal communication impairment
* infection in skin at injection site
* coagulopathy
* technique refusal

Primary outcomes:
measure: postoperative pain intensity (P3). Self reported pain intensity at 6, 12 and 24 hours after surgery.
timeFrame: 1 day
Secondary outcomes:
measure: Rescue Analgesia (R3) need of opioid medication for rescue severe postoperative pain at 6, 12 and 24 hours after surgery.
timeFrame: 1 day
Other outcomes:
measure: motor block
timeFrame: 2 hours post surgical
Locations:
city: Medellin
country: Colombia
facility: hospital universitario San Vicente Fundacion
state: Antioquia
Study officials:
affiliation: Anesthesiology Professor
name: Adriana M Cadavid, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shin S, Kim JY, Kim WO, Kim SH, Kil HK. Ultrasound visibility of spinal structures and local anesthetic spread in children undergoing caudal block. Ultrasound Med Biol. 2014 Nov;40(11):2630-6. doi: 10.1016/j.ultrasmedbio.2014.06.020. Epub 2014 Sep 12.
citation: Ibacache ME, Munoz HR, Fuentes R, Cortinez LI. Dexmedetomidine-ketamine combination and caudal block for superficial lower abdominal and genital surgery in children. Paediatr Anaesth. 2015 May;25(5):499-505. doi: 10.1111/pan.12642. Epub 2015 Mar 4.
citation: Doo AR, Kim JW, Lee JH, Han YJ, Son JS. A Comparison of Two Techniques for Ultrasound-guided Caudal Injection: The Influence of the Depth of the Inserted Needle on Caudal Block. Korean J Pain. 2015 Apr;28(2):122-8. doi: 10.3344/kjp.2015.28.2.122. Epub 2015 Apr 1.