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NCT Number: NCT03345511

Ultrasound Guided Caudal Block for Benign Anal Surgery

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

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

hospital universitario San Vicente Fundacion

Medellín, Antioquia, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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 outcomes

  1. 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 outcomes

  1. motor block

    Time frame: 2 hours post surgical

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

Sponsors and collaborators

Lead sponsor

Universidad de Antioquia

Other

Registry information

Official study title

Ultrasound Guided Analgesic Caudal Block in Anal Canal Surgery

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 17, 2017
Registry last updated
Apr 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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