AnalgesiaNCT04921007
Ultrasound Guided Sacral Erector Spinae Plane Block in Pediatric Anorectal Surgery
A study testing Sacral ESP block, Caudal block and Bupivacaine Hydrochloride in people with Analgesia, run by Sameh Fathy at 1 site in Egypt.
Trial summary
This study will be conducted to evaluate efficacy of ultrasound guided sacral erector spinae plane block for postoperative analgesia in pediatric anorectal surgery in comparison to caudal block. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Sacral ESP block, Caudal block and Bupivacaine Hydrochloride
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Aug 2021to 1 Jul 2022
- 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 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiology (ASA) I and II patients.
- Scheduled for pediatric anorectal surgery
Who cannot join
- Parental refusal of consent.
- Children with developmental delays, mental or neurological disorders.
- Bleeding or coagulation diathesis.
- History of known sensitivity to the used anesthetics.
- Infection or redness at the injection site.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Anesthesia, Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, 35511
About this study
Official title: Analgesic Efficacy of Ultrasound Guided Sacral Erector Spinae Plane Block Versus Caudal Block in Pediatric Anorectal Surgery
This study will be conducted to evaluate efficacy of ultrasound guided sacral erector spinae plane block for postoperative analgesia in pediatric anorectal surgery in comparison to caudal block.
Read the detailed description
Regional anesthesia in children has become increasingly popular over the past few decades. A variety of peripheral and central nerve blocks have been developed to ensure that perioperative pain can be effectively controlled. So, it possible to reduce the dose concentrations of systemic drugs and improved hemodynamic stability in high-risk patients. Erector spinae plane (ESP) block with various approaches been used in many surgeries and obtained great popularity despite of its novelty. After first description; lower thoracic, lumbar and sacral approaches were defined for postoperative analgesia. There are a few cases in which sacral ESP block was administered and reported.
The aim of this study is to compare postoperative analgesic effect of ultrasound guided sacral ESP block and caudal block. It is hypothesized that sacral ESP block will be comparable to caudal block as a promising effective alternative for analgesia in patients who will undergo pediatric anorectal surgery with fewer side effects.
This prospective, randomized, comparative clinical study will include 60 children who will be scheduled for elective anorectal surgery under general anesthesia in Mansoura university hospitals. Informed written consent will be obtained from parents of all subjects in the study after ensuring confidentiality. The study protocol will be explained to parents of all patients in the study who will be kept fasting prior to surgery. Patients will be randomly assigned to two equal groups (ESP and caudal) according to computer-generated table of random numbers using the permuted block randomization method. The collected data will be coded, processed, and analyzed using SPSS program. All data will be considered statistically significant if P value is ≤ 0.05.
- Conditions
- Analgesia
- Being tested
- Sacral ESP block, Caudal block, Bupivacaine Hydrochloride
- Keywords
- Erector spinae plane block, Ultrasound guided, Sacral, Anorectal surgery
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral ESP blockProcedure or surgery
Also called Ultrasound guided approach
A high-frequency ultrasound linear probe covered with a sterile sheath will be placed longitudinally to the midline of the sacrum. The median sacral crests and erector spinae muscle will be visualized, then a 22-gauge, 50 mm needle will be advanced from cranial to caudal direction until its tip touch the sacral crest.
Caudal blockProcedure or surgery
Also called Ultrasound guided approach
A high-frequency ultrasound linear probe covered with a sterile sheath will be placed on to the sacrococcygeal region. The dura mater, epidural space, conus medullaris, sacral cornua, and sacrococcygeal ligament will be identified. Using the in-plane technique, a 22-gauge, 50 mm needle will be introduced to reach the sacral epidural space.
Bupivacaine HydrochlorideDrug
Also called Marcaine
Following negative aspiration, a precalculated dose (0.5 ml/kg) of 0.25% bupivacaine will be injected.
| Study group | Role | What they receive |
|---|---|---|
| Group (A) Sacral ESP block | Active comparator | Ultrasound guided sacral erector spinae plane (ESP) block will be performed in the lateral position under sterile conditions, and bupivacaine will be administered. Receives: Procedure: Sacral ESP block; Drug: Bupivacaine Hydrochloride |
| Group (B) Caudal block | Active comparator | Ultrasound guided caudal block will be performed in the lateral position under sterile conditions, and bupivacaine will be administered. Receives: Procedure: Caudal block; Drug: Bupivacaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration for the first analgesic request
The time of the first analgesic request for paracetamol in minutes will be recorded.
Measured: Up to 24 hours after the procedure
Secondary outcomes (6)
Total analgesic requirements of paracetamol
The amount of paracetamol consumption in milligrams given as a rescue analgesia
Measured: Up to 24 hours after the procedure
Improvement in pain scores
Pain score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain) is assessed postoperatively at 1, 2, 4, 8, 12, 24 hours
Measured: Up to 24 hours after the procedure
Changes in heart rate
Heart rate (beat/min) is recorded at ten-minute intervals until the end of the surgery.
Measured: Up to end of the surgery
Changes in mean arterial blood pressure
Blood pressure (mmHg) is recorded at ten-minute intervals until the end of the surgery.
Measured: Up to end of the surgery
Changes in postoperative emergence agitation scale
Agitation is assessed using the 5- step Cravero scale (1-5) every five minutes from awakening and for 30 minutes.(1:Obtunded with no response to stimulation, 2:Asleep but responsive to movement or stimulation, 3:Awake and responsive, 4:Crying, 5:Thrashing behaviour that requires restraint)
Measured: Up to 30 minutes after the procedure
Value of parent satisfaction from the procedure
The parents will be investigated postoperatively for the quality of the procedure verbally (0-10; 0=None, 10=total satisfaction)
Measured: Up to 24 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start13 Aug 2021
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sameh Fathy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sameh Fathy, Mansoura University
- Investigators
- Sameh M El-Sherbiny, MD, Principal investigator, Mansoura Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921007
- Sponsor's protocol ID
- Sacral ESP Block
- Status last verified
- Jul 2022
- First submitted
- 3 Jun 2021
- Last updated
- 7 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Ultrasound Guided Sacral Erector Spinae Plane Block Versus Caudal Block in Pediatric Anorectal Surgery
- ClinicalTrials.gov ID
- NCT04921007
- Acronym / sponsor ID
- Sacral ESP Block
- Conditions
- Analgesia
- Keywords
- Erector spinae plane block, Ultrasound guided, Sacral, Anorectal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sameh FathyUniversity, hospital or other
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 10 Jun 2021 (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.
This study will be conducted to evaluate efficacy of ultrasound guided sacral erector spinae plane block for postoperative analgesia in pediatric anorectal surgery in comparison to caudal block.
Detailed description
Regional anesthesia in children has become increasingly popular over the past few decades. A variety of peripheral and central nerve blocks have been developed to ensure that perioperative pain can be effectively controlled. So, it possible to reduce the dose concentrations of systemic drugs and improved hemodynamic stability in high-risk patients. Erector spinae plane (ESP) block with various approaches been used in many surgeries and obtained great popularity despite of its novelty. After first description; lower thoracic, lumbar and sacral approaches were defined for postoperative analgesia. There are a few cases in which sacral ESP block was administered and reported.
The aim of this study is to compare postoperative analgesic effect of ultrasound guided sacral ESP block and caudal block. It is hypothesized that sacral ESP block will be comparable to caudal block as a promising effective alternative for analgesia in patients who will undergo pediatric anorectal surgery with fewer side effects.
This prospective, randomized, comparative clinical study will include 60 children who will be scheduled for elective anorectal surgery under general anesthesia in Mansoura university hospitals. Informed written consent will be obtained from parents of all subjects in the study after ensuring confidentiality. The study protocol will be explained to parents of all patients in the study who will be kept fasting prior to surgery. Patients will be randomly assigned to two equal groups (ESP and caudal) according to computer-generated table of random numbers using the permuted block randomization method. The collected data will be coded, processed, and analyzed using SPSS program. All data will be considered statistically significant if P value is ≤ 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) Sacral ESP block | Active comparator | Procedure: Sacral ESP block, Drug: Bupivacaine HydrochlorideUltrasound guided sacral erector spinae plane (ESP) block will be performed in the lateral position under sterile conditions, and bupivacaine will be administered. |
| Group (B) Caudal block | Active comparator | Procedure: Caudal block, Drug: Bupivacaine HydrochlorideUltrasound guided caudal block will be performed in the lateral position under sterile conditions, and bupivacaine will be administered. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- American Society of Anesthesiology (ASA) I and II patients.
- Scheduled for pediatric anorectal surgery
Key exclusion criteria (5 listed)
- Parental refusal of consent.
- Children with developmental delays, mental or neurological disorders.
- Bleeding or coagulation diathesis.
- History of known sensitivity to the used anesthetics.
- Infection or redness at the injection site.
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 |
|---|---|---|
| Sacral ESP blockAlso: Ultrasound guided approachA high-frequency ultrasound linear probe covered with a sterile sheath will be placed longitudinally to the midline of the sacrum. The median sacral crests and erector spinae muscle will be visualized, then a 22-gauge, 50 mm needle will be advanced from cranial to caudal direction until its tip touch the sacral crest. | Procedure or surgery | Group (A) Sacral ESP block |
| Caudal blockAlso: Ultrasound guided approachA high-frequency ultrasound linear probe covered with a sterile sheath will be placed on to the sacrococcygeal region. The dura mater, epidural space, conus medullaris, sacral cornua, and sacrococcygeal ligament will be identified. Using the in-plane technique, a 22-gauge, 50 mm needle will be introduced to reach the sacral epidural space. | Procedure or surgery | Group (B) Caudal block |
| Bupivacaine HydrochlorideAlso: MarcaineFollowing negative aspiration, a precalculated dose (0.5 ml/kg) of 0.25% bupivacaine will be injected. | Drug | Group (A) Sacral ESP block, Group (B) Caudal block |
Primary outcome
Duration for the first analgesic request
Time frame: Up to 24 hours after the procedure
The time of the first analgesic request for paracetamol in minutes will be recorded.
6 secondary outcomes
Total analgesic requirements of paracetamol
Time frame: Up to 24 hours after the procedure
Improvement in pain scores
Time frame: Up to 24 hours after the procedure
Changes in heart rate
Time frame: Up to end of the surgery
Changes in mean arterial blood pressure
Time frame: Up to end of the surgery
Changes in postoperative emergence agitation scale
Time frame: Up to 30 minutes after the procedure
Value of parent satisfaction from the procedure
Time frame: Up to 24 hours after the procedure
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 7 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Sameh M El-Sherbiny, MD principal investigator
Mansoura Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacral ESP block, Caudal block and Bupivacaine Hydrochloride in people with Analgesia, run by Sameh Fathy at 1 site in Egypt.
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 2 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 7 Jul 2022. 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 Egypt. 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?
Duration for the first analgesic request (time frame: Up to 24 hours after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2022.