Pediatric- Epidural Analgesia -Palpation-ultrasoundUS_epiduralNCT05331157
Ultrasound Epidural Technique
A study testing ultrasound in people with Pediatric- Epidural Analgesia -Palpation-ultrasound, run by Mansoura University at 1 site in Egypt.
Trial summary
Epidural analgesia for abdominal surgeries provides numerous advantages for both neonates and children. The anatomical identification of the intervertebral space to access the epidural space is not constantly easy this is due uncertainty of the direction of the needle angle and the difficulty to estimate the epidural… Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Pediatric- Epidural Analgesia -Palpation-ultrasound
- What is being tested?
- ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 20 Sep 2023
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients aged from 1 to 12 years old
- Both genders
- American Society of Anesthesiologists (ASA) physical status I,II, III
- Scheduled for open midabdominal urological surgeries under general anesthesia
Who cannot join
- Pediatric patients aged less than 1 or more than 12 years old
- American Society of Anesthesiologists (ASA) physical status Iv
- Parents' refusal to participate in the study
- Any contraindication to epidural block (as severe infection at the puncture site, coagulopathy or hemodynamically unstable patients)
- Neuromuscular diseases
- Severe spinal deformity
- History of allergy to the anesthetic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonically Versus Conventional Palpation for Epidural Analgesia in Pediatrics Undergoing Midabdominal Urological Operations
Epidural analgesia for abdominal surgeries provides numerous advantages for both neonates and children. The anatomical identification of the intervertebral space to access the epidural space is not constantly easy this is due uncertainty of the direction of the needle angle and the difficulty to estimate the epidural depth in spite of the skill of the operator. This can lead to more puncture attempts, inducing more pain or discomfort and even failure of epidural access.
Pre-procedure neuraxial ultrasound (US) imaging facilities the identification of the chosen intervertebral space, the depth of the epidural space and so the selection of best point and angle for the needle insertion
Read the detailed description
The aim of this study is to evaluate the efficacy of prepuncture ultrasonography to facilitate epidural block in pediatric patients undergoing elective urological operations compared with the conventional anatomical landmark technique
- Being tested
- ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
the efficacy of prepuncture ultrasonography to facilitate epidural block in pediatric patients undergoing elective urological operations compared with the conventional anatomical landmark technique
| Study group | Role | What they receive |
|---|---|---|
| palpation group | No intervention | In lateral decubitus position, the conventional palpation technique will be used to detect the epidural space. The midline will be identified by palpation of the spinous processes. Through the Tuffier's line, L5 spine then, the two intervertebral spaces (L3-4 and L2-3) will be detected and the middle of each intervertebral space will be marked with selection of the widest space. After sterilization of the patient's skin the needle will be inserted to detect the epidural space by using loss of resistance to saline |
| Ultrasonography group | Experimental | In lateral decubitus position, a curved array probe will be utilized to scan the sacrum in the longitudinal paramedian plane, then the probe will be moved upwards to detect the L5-S1, L4-5, L3-4 and L2-3 intervertebral spaces then turned 90º to the transverse plane and used to scan L3-4 and L2-3 spaces inside the 2 spaces, midline will be detected by noting the site of spinous processes with selection of the space with the best sonographic image quality. Then skin surface at the middle of the long and short axis of the probe will be marked horizontally. If the 2 spaces have the same image quality, L2-3 space will be chosen for the entrance of epidural needle. After sterilization of the patient's skin the needle will be inserted to detect the epidural space by using loss of resistance to saline Receives: Device: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of a successful reaching to the epidural space from the first needle pass
incidence after insertion of the epidural needle into the skin till reaching the epidural space
Measured: minutes
Secondary outcomes (10)
the rate of a successful reaching to the epidural space from the first skin puncture
incidence after insertion of the epidural needle into the skin till reaching the epidural space
Measured: minutes
The number of performed skin punctures by the epidural needle
number after insertion of the epidural needle into the skin till reaching the epidural space
Measured: minutes
The number of needle passes from the same skin puncture required for reaching the epidural space
number from the skin puncture done by the epidural needle till removing the epidural needle from this the skin puncture
Measured: minutes
The epidural space demarcation time by the ultrasound
The time from placing the ultrasound probe on the skin until the skin marking is completed at L3-4 and L2-3 space
Measured: minutes
The epidural space demarcation time by the landmark
The time from start skin palpation til the skin marking is completed at L3-4 and L2-3 space
Measured: minutes
The procedure time which is the time from the needle insertion into the skin until reaching the epidural space
Measured: minutes
Incidence of intraoperative hypertension (as increase in systolic blood pressure (SBP) by more than 20% from the basal)
mmHg
Measured: allover the surgery (minutes)
Incidence of intraoperative tachycardia (as increase in heart rate by more than 20% from the basal)
beat per minutes
Measured: allover the surgery (minutes)
The procedure time
from the needle insertion into the skin till entering the epidural space
Measured: minutes
pain score using "face, leg, activity, cry, consolability" (FLACC) scale
five criteria, which are each assigned a score of 0, 1 or 2
Measured: 30 minutes after the patient has transferred to the recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start1 May 2022
- Primary completion1 Aug 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric- Epidural Analgesia -Palpation-ultrasoundStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maha abou-zeid, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331157
- Sponsor's protocol ID
- Ultrasound epidural
- Acronym
- US_epidural
- Status last verified
- Oct 2023
- First submitted
- 28 Mar 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonically Versus Conventional Palpation for Epidural Analgesia in Pediatrics Undergoing Midabdominal Urological Operations
- ClinicalTrials.gov ID
- NCT05331157
- Acronym / sponsor ID
- US_epidural / Ultrasound epidural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 15 Apr 2022 (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.
Epidural analgesia for abdominal surgeries provides numerous advantages for both neonates and children. The anatomical identification of the intervertebral space to access the epidural space is not constantly easy this is due uncertainty of the direction of the needle angle and the difficulty to estimate the epidural depth in spite of the skill of the operator. This can lead to more puncture attempts, inducing more pain or discomfort and even failure of epidural access.
Pre-procedure neuraxial ultrasound (US) imaging facilities the identification of the chosen intervertebral space, the depth of the epidural space and so the selection of best point and angle for the needle insertion
Detailed description
The aim of this study is to evaluate the efficacy of prepuncture ultrasonography to facilitate epidural block in pediatric patients undergoing elective urological operations compared with the conventional anatomical landmark technique
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| palpation group | No intervention | –In lateral decubitus position, the conventional palpation technique will be used to detect the epidural space. The midline will be identified by palpation of the spinous processes. Through the Tuffier's line, L5 spine then, the two intervertebral spaces (L3-4 and L2-3) will be detected and the middle of each intervertebral space will be marked with selection of the widest space. After sterilization of the patient's skin the needle will be inserted to detect the epidural space by using loss of resistance to saline |
| Ultrasonography group | Experimental | Device: ultrasoundIn lateral decubitus position, a curved array probe will be utilized to scan the sacrum in the longitudinal paramedian plane, then the probe will be moved upwards to detect the L5-S1, L4-5, L3-4 and L2-3 intervertebral spaces then turned 90º to the transverse plane and used to scan L3-4 and L2-3 spaces inside the 2 spaces, midline will be detected by noting the site of spinous processes with selection of the space with the best sonographic image quality. Then skin surface at the middle of the long and short axis of the probe will be marked horizontally. If the 2 spaces have the same image quality, L2-3 space will be chosen for the entrance of epidural needle. After sterilization of the patient's skin the needle will be inserted to detect the epidural space by using loss of resistance to saline |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pediatric patients aged from 1 to 12 years old
- Both genders
- American Society of Anesthesiologists (ASA) physical status I,II, III
- Scheduled for open midabdominal urological surgeries under general anesthesia
Key exclusion criteria (7 listed)
- Pediatric patients aged less than 1 or more than 12 years old
- American Society of Anesthesiologists (ASA) physical status Iv
- Parents' refusal to participate in the study
- Any contraindication to epidural block (as severe infection at the puncture site, coagulopathy or hemodynamically unstable patients)
- Neuromuscular diseases
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 |
|---|---|---|
| ultrasoundthe efficacy of prepuncture ultrasonography to facilitate epidural block in pediatric patients undergoing elective urological operations compared with the conventional anatomical landmark technique | Device | Ultrasonography group |
Primary outcome
the rate of a successful reaching to the epidural space from the first needle pass
Time frame: minutes
incidence after insertion of the epidural needle into the skin till reaching the epidural space
10 secondary outcomes
the rate of a successful reaching to the epidural space from the first skin puncture
Time frame: minutes
The number of performed skin punctures by the epidural needle
Time frame: minutes
The number of needle passes from the same skin puncture required for reaching the epidural space
Time frame: minutes
The epidural space demarcation time by the ultrasound
Time frame: minutes
The epidural space demarcation time by the landmark
Time frame: minutes
The procedure time which is the time from the needle insertion into the skin until reaching the epidural space
Time frame: minutes
Incidence of intraoperative hypertension (as increase in systolic blood pressure (SBP) by more than 20% from the basal)
Time frame: allover the surgery (minutes)
Incidence of intraoperative tachycardia (as increase in heart rate by more than 20% from the basal)
Time frame: allover the surgery (minutes)
The procedure time
Time frame: minutes
pain score using "face, leg, activity, cry, consolability" (FLACC) scale
Time frame: 30 minutes after the patient has transferred to the recovery room
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 23 Oct 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Pediatric- Epidural Analgesia -Palpation-ultrasound, run by Mansoura University 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 4 inclusion and 7 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 23 Oct 2023. 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?
the rate of a successful reaching to the epidural space from the first needle pass (time frame: minutes). 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 23 Oct 2023.