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Ultrasound Guided Caudal Block for Benign Anal Surgery

Primary Purpose

Anal Fissure, Anal Fistula, Hemorrhoids

Status

Completed

Phase

Not Applicable

Locations

Colombia

Study Type

Interventional

Intervention

Ultrasound Guided Caudal Block

About this trial

This is an interventional treatment trial for Anal Fissure focused on measuring ultrasound guided caudal block, anal surgery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

hospital universitario San Vicente Fundacion

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ultrasound Guided Caudal Block

Arm Description

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.

Outcomes

Primary Outcome Measures

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")

Secondary Outcome Measures

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

Full Information

NCT ID

NCT03345511

First Posted

November 7, 2017

Last Updated

April 27, 2018

Sponsor

Universidad de Antioquia

1. Study Identification

Unique Protocol Identification Number

NCT03345511

Brief Title

Ultrasound Guided Caudal Block for Benign Anal Surgery

Official Title

Ultrasound Guided Analgesic Caudal Block in Anal Canal Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

November 1, 2015 (Actual)

Primary Completion Date

May 30, 2016 (Actual)

Study Completion Date

June 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universidad de Antioquia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anal Fissure, Anal Fistula, Hemorrhoids, Pain, Postoperative

Keywords

ultrasound guided caudal block, anal surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

interventional

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ultrasound Guided Caudal Block

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Ultrasound Guided Caudal Block

Intervention Description

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.

Primary Outcome Measure Information:

Title

postoperative pain intensity (P3). Self reported pain intensity at 6, 12 and 24 hours after surgery.

Description

Time Frame

1 day

Secondary Outcome Measure Information:

Title

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

Description

Doses of intravenous tramadol for rescue in severe postoperative pain

Time Frame

1 day

Other Pre-specified Outcome Measures:

Title

motor block

Description

presence or absence of motor block in lower extremity after caudal block

Time Frame

2 hours post surgical

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adriana M Cadavid, MD

Organizational Affiliation

Anesthesiology Professor

Official's Role

Principal Investigator

Facility Information:

Facility Name

hospital universitario San Vicente Fundacion

City

Medellin

State/Province

Antioquia

Country

Colombia

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

only final results of research

Citations:

PubMed Identifier

25220270

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.

Results Reference

background

PubMed Identifier

25736098

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.

Results Reference

background

PubMed Identifier

25852834

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.

Results Reference

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Ultrasound Guided Caudal Block for Benign Anal Surgery

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