Ultrasound Guided Caudal Block for Benign Anal Surgery

NCT03345511 | Completed DMC

• 1 other identifier: UdeA1001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anal Fissure; Anal Fistula; Hemorrhoids; Pain, Postoperative

Keywords

ultrasound guided caudal block; anal surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rescue Analgesia (R3) need of opioid medication for rescue severe postoperative pain at 6, 12 and 24 hours after surgery.

  1 day

Other Outcomes (1)

• motor block

  2 hours post surgical

Study Arms (1)

Ultrasound Guided Caudal Block

EXPERIMENTAL

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

Interventions

Ultrasound Guided Caudal Block PROCEDURE

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.

Ultrasound Guided Caudal Block

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Antioquia: lead

Study Sites (1)

hospital universitario San Vicente Fundacion

Medellín, Antioquia, Colombia

Location

Related Publications (3)

• 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.

  PMID: 25220270 BACKGROUND

• 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.

  PMID: 25736098 BACKGROUND

• 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.

  PMID: 25852834 BACKGROUND

MeSH Terms

Conditions

Fissure in Ano; Rectal Fistula; Hemorrhoids; Pain, Postoperative

Condition Hierarchy (Ancestors)

Anus Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Adriana M Cadavid, MD

  Anesthesiology Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: interventional

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: November 17, 2017
• Study Start: November 1, 2015
• Primary Completion: May 30, 2016
• Study Completion: June 30, 2016
• Last Updated: April 30, 2018

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)