Ultrasound Guided Caudal Block for Benign Anal Surgery

Pain, Postoperative Clinical Trial

Official title:

Ultrasound Guided Analgesic Caudal Block in Anal Canal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03345511
• Other study ID #: UdeA1001
• Status: Completed
• Phase: N/A
• Start date: November 1, 2015
• Est. completion date: June 30, 2016

Study information

• Verified date: February 2017
• Source: Universidad de Antioquia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 30, 2016
• Est. primary completion date: May 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anal Fissure
• Anal Fistula
• Fissure in Ano
• Fistula
• Hemorrhoids
• Pain, Postoperative
• Rectal Fistula

Intervention

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.

Locations

Country	Name	City	State
Colombia	hospital universitario San Vicente Fundacion	Medellin	Antioquia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

References & Publications (3)

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. — View Citation

Ibacache ME, Muñoz HR, Fuentes R, Cortínez 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	motor block	presence or absence of motor block in lower extremity after caudal block	2 hours post surgical
Primary	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")	1 day
Secondary	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	1 day