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Ultrasound Guided Caudal Block for Benign Anal Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03345511
First Posted: November 17, 2017
Last Update Posted: November 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Universidad de Antioquia
  Purpose
Interventional study that evaluate analgesia and side effects of Ultrasound guided Caudal block preoperatively in benign canal anal surgery

Condition Intervention
Anal Fissure Anal Fistula Hemorrhoids Pain, Postoperative Procedure: Ultrasound Guided Caudal Block

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
interventional
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultrasound Guided Analgesic Caudal Block in Anal Canal Surgery

Resource links provided by NLM:


Further study details as provided by Universidad de Antioquia:

Primary Outcome Measures:
  • postoperative pain intensity (P3). Self reported pain intensity at 6, 12 and 24 hours after surgery. [ Time Frame: 1 day ]
    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. [ Time Frame: 1 day ]
    Doses of intravenous tramadol for rescue in severe postoperative pain


Other Outcome Measures:
  • motor block [ Time Frame: 2 hours post surgical ]
    presence or absence of motor block in lower extremity after caudal block


Enrollment: 23
Actual Study Start Date: November 1, 2015
Study Completion Date: June 30, 2016
Primary Completion Date: May 30, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultrasound Guided Caudal Block
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03345511


Locations
Colombia
hospital universitario San Vicente Fundacion
Medellin, Antioquia, Colombia
Sponsors and Collaborators
Universidad de Antioquia
Investigators
Principal Investigator: Adriana M Cadavid, MD Anesthesiology Professor
  More Information

Publications:
Responsible Party: Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT03345511     History of Changes
Other Study ID Numbers: UdeA1001
First Submitted: November 7, 2017
First Posted: November 17, 2017
Last Update Posted: November 22, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: only final results of research

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universidad de Antioquia:
ultrasound guided caudal block
anal surgery

Additional relevant MeSH terms:
Fistula
Pain, Postoperative
Hemorrhoids
Rectal Fistula
Fissure in Ano
Pathological Conditions, Anatomical
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Intestinal Fistula
Digestive System Fistula
Anus Diseases