Anal FissureNCT03345511
Ultrasound Guided Caudal Block for Benign Anal Surgery
A study testing Ultrasound Guided Caudal Block in people with Anal Fissure and Anal Fistula, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
Interventional study that evaluate analgesia and side effects of Ultrasound guided Caudal block preoperatively in benign canal anal surgery Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anal Fissure, Anal Fistula, Hemorrhoids
- What is being tested?
- Ultrasound Guided Caudal Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteColombia
- Study dates
- 1 Nov 2015to 30 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- cognitive impairment
- verbal communication impairment
- infection in skin at injection site
- coagulopathy
- technique refusal
Trial locations and contacts
1 site in 1 country.
Colombia1 site
hospital universitario San Vicente Fundacion
Medellín, Antioquia
About this study
Official title: Ultrasound Guided Analgesic Caudal Block in Anal Canal Surgery
Interventional study that evaluate analgesia and side effects of Ultrasound guided Caudal block preoperatively in benign canal anal surgery
Read the 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.
- Conditions
- Anal Fissure, Anal Fistula, Hemorrhoids, Pain, Postoperative
- Being tested
- Ultrasound Guided Caudal Block
- Keywords
- ultrasound guided caudal block, anal surgery
- Medical subject headings
- Fissure in Ano, Rectal Fistula, Hemorrhoids, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Guided Caudal BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Guided Caudal Block | Experimental | 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. Receives: Procedure: Ultrasound Guided Caudal Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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")
Measured: 1 day
Secondary outcomes (1)
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Nov 2015
- Primary completion30 May 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anal FissureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- interventional
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adriana M Cadavid, MD, Principal investigator, Anesthesiology Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345511
- Sponsor's protocol ID
- UdeA1001
- Status last verified
- Feb 2017
- First submitted
- 7 Nov 2017
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only final results of research
Publications
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.
PubMed 25220270Ibacache 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.
PubMed 25736098Doo 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.
PubMed 25852834
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Analgesic Caudal Block in Anal Canal Surgery
- ClinicalTrials.gov ID
- NCT03345511
- Acronym / sponsor ID
- UdeA1001
- Conditions
- Anal Fissure, Anal Fistula, Hemorrhoids, Pain, Postoperative
- Keywords
- ultrasound guided caudal block, anal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 30 May 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- interventional
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Guided Caudal Block | Experimental | Procedure: Ultrasound Guided Caudal Block30 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- cognitive impairment
- verbal communication impairment
- infection in skin at injection site
- coagulopathy
- technique refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound Guided Caudal BlockUsing 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. | Procedure or surgery | Ultrasound Guided Caudal Block |
Primary outcome
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")
1 secondary outcome
Rescue Analgesia (R3) need of opioid medication for rescue severe postoperative pain at 6, 12 and 24 hours after surgery.
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
- Background: PubMed 25220270Shin 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.
- Background: PubMed 25736098Ibacache 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.
- Background: PubMed 25852834Doo 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.
- Individual participant dataSharing planned: No. only final results of research
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriana M Cadavid, MD principal investigator
Anesthesiology Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Guided Caudal Block in people with Anal Fissure and Anal Fistula, run by Universidad de Antioquia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain intensity (P3). Self reported pain intensity at 6, 12 and 24 hours after surgery. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03345511, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2018.