Ultrasound Guided Caudal Block for Benign Anal Surgery

Not Applicable

Completed

• Conditions: Anal Fistula; Hemorrhoids; Anal Fissure; Pain, Postoperative
• Interventions: Procedure: Ultrasound Guided Caudal Block

• Registration Number: NCT03345511
• Lead Sponsor: Universidad de Antioquia

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.

Study Timeline

• Study Start: 2015-11-01
• Primary Completion: 2016-05-30
• Study Completion: 2016-06-30
• Status Verified: 2017-02
• Study First Submitted: 2017-11-07
• Study First Submitted QC: 2017-11-15
• Study First Posted: 2017-11-17
• Last Update Submitted: 2018-04-27
• Last Update Posted: 2018-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound Guided Caudal Block	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.

Primary Outcome Measures

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

Name	Time	Method
Rescue Analgesia (R3) need of opioid medication for rescue severe postoperative pain at 6, 12 and 24 hours after surgery.	1 day	Doses of intravenous tramadol for rescue in severe postoperative pain

Trial Locations

Locations (1)

hospital universitario San Vicente Fundacion; 🇨🇴 Medellin, Antioquia, Colombia