Ultrasound Guided Caudal Block for Benign Anal Surgery
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| ClinicalTrials.gov Identifier: NCT03345511 |
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Recruitment Status :
Completed
First Posted : November 17, 2017
Last Update Posted : April 30, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anal Fissure Anal Fistula Hemorrhoids Pain, Postoperative | Procedure: Ultrasound Guided Caudal Block | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 23 participants |
| Allocation: | N/A |
| 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 |
| Actual Study Start Date : | November 1, 2015 |
| Actual Primary Completion Date : | May 30, 2016 |
| Actual Study Completion Date : | June 30, 2016 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
- 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")
- 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
- motor block [ Time Frame: 2 hours post surgical ]presence or absence of motor block in lower extremity after caudal block
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| Colombia | |
| hospital universitario San Vicente Fundacion | |
| Medellin, Antioquia, Colombia | |
| Principal Investigator: | Adriana M Cadavid, MD | Anesthesiology Professor |
| Responsible Party: | Universidad de Antioquia |
| ClinicalTrials.gov Identifier: | NCT03345511 |
| Other Study ID Numbers: |
UdeA1001 |
| First Posted: | November 17, 2017 Key Record Dates |
| Last Update Posted: | April 30, 2018 |
| 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 |
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ultrasound guided caudal block anal surgery |
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Hemorrhoids Rectal Fistula Fissure in Ano Fistula Pain, Postoperative Pathological Conditions, Anatomical Postoperative Complications Pathologic Processes Pain Neurologic Manifestations |
Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Vascular Diseases Cardiovascular Diseases Intestinal Fistula Digestive System Fistula Anus Diseases |