Postoperative AnalgesiaNCT04690894
Erector Spinae Muscle Block Versus Caudal Block by Sonar in Pediatrics Undergoing Lower Abdominal Surgery
A study testing erector spinae block - caudal block in people with Postoperative Analgesia, run by Minia University at 1 site in Egypt.
Trial summary
this prospective randomized double blind controlled study was conducted on 60 child scheduled for lower abdominal surgery under general anesthesia. the patients were randomly allocated into 3 parallel groups.group (ESB) patients received ultrasound-guided erector spinae block in a dose of 0.4mg/ml of 0.25%bupivacaine… Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- erector spinae block - caudal block
- 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
- 15 Jul 2019to 15 Feb 2020
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pediatric patients aged 2-6 years scheduled for lower abdominal surgery under general anesthesia
Who cannot join
- parent refusal
- spinal and meningeal anomalies
- mental retardation
- blood disease
- infection at site of injection
- drug allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Erector Spinae Muscle Block Versus Ultrasound-guided Caudal Block in Pediatric Patient Undergoing Lower Abdominal Surgery
this prospective randomized double blind controlled study was conducted on 60 child scheduled for lower abdominal surgery under general anesthesia. the patients were randomly allocated into 3 parallel groups.group (ESB) patients received ultrasound-guided erector spinae block in a dose of 0.4mg/ml of 0.25%bupivacaine between the 10th transverse process and erector spinae muscles.group(CB) patients received ultrasound-guided caudal block in a dose of 2.5mg/kg of 0.25%bupivacaine. group(CO) did,t received any block
Read the detailed description
on arrival of the patients to the operative theatre and after placement of the standard monitoring general inhalational anesthesia was induced by face mask with sevoflurane (4-8%) in oxygen after IV cannula was secured patients received 1mic/kg fentanyl and intubation was facilitated by 0.5mg/kg atracurium. isoflurane 1-2% with oxygen was used for maintenance of anesthesia. after stabilization of the patient's hemodynamics and before skin incision erector spinae block or caudal block was performed with the patient in lateral position. after the block patients were flipped back to their normal supine position, surgery took place 10 min after injection of local anesthetic. after termination of surgery reversal of the atracurium was done by giving neostigmine in a dose of 0.04mg/kg and atropine 0.02mg/kg and awake extubation was done
- Conditions
- Postoperative Analgesia
- Being tested
- erector spinae block - caudal block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinae block - caudal blockProcedure or surgery
the child placed in lateral position identification of spinous process of 10th thoracic vertebral then the transducer was moved 2.5 cm laterally to visualize the transverse process and a total of 0.4mg/kg of 0.25%bupivacaine was adminstered
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae group | Active comparator | the child received ultrasound-guided erector spinae muscle block in a dose of 0.4mg/kg of 0.25%bupivacaine between the 10th transverse process and erector spinae muscle Receives: Procedure: erector spinae block - caudal block |
| caudal group | Active comparator | child received ultrasound-guided caudal block in a dose of 2.5mg/kg of bupivacaine 0.25% Receives: Procedure: erector spinae block - caudal block |
| control | No intervention | child didn't received any regional block |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients need rescue analgesia
total number of patients need addition of anagesia
Measured: 24 hours
Secondary outcomes (2)
First analgesic request
First time that patient require analgesia
Measured: 24 hours
Hemodynamic changes in the study period
Changes in HR and blood pressure
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start15 Jul 2019
- Primary completion15 Jan 2020
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shadwa Rabea Mohamed, Minia University
- Investigators
- Ibrahim Talaat, MD, Study director, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690894
- Sponsor's protocol ID
- 266:7/2019
- Status last verified
- May 2019
- First submitted
- 28 Dec 2020
- Last updated
- 8 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdelrazik AN, Ibrahim IT, Farghaly AE, Mohamed SR. Ultrasound-guided Erector Spinae Muscle Block Versus Ultrasound-guided Caudal Block in Pediatric Patients Undergoing Lower Abdominal Surgeries. Pain Physician. 2022 Jul;25(4):E571-E580.
PubMed 35793181
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Erector Spinae Muscle Block Versus Ultrasound-guided Caudal Block in Pediatric Patient Undergoing Lower Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04690894
- Acronym / sponsor ID
- 266:7/2019
- Conditions
- Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 31 Dec 2020 (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 prospective randomized double blind controlled study was conducted on 60 child scheduled for lower abdominal surgery under general anesthesia. the patients were randomly allocated into 3 parallel groups.group (ESB) patients received ultrasound-guided erector spinae block in a dose of 0.4mg/ml of 0.25%bupivacaine between the 10th transverse process and erector spinae muscles.group(CB) patients received ultrasound-guided caudal block in a dose of 2.5mg/kg of 0.25%bupivacaine. group(CO) did,t received any block
Detailed description
on arrival of the patients to the operative theatre and after placement of the standard monitoring general inhalational anesthesia was induced by face mask with sevoflurane (4-8%) in oxygen after IV cannula was secured patients received 1mic/kg fentanyl and intubation was facilitated by 0.5mg/kg atracurium. isoflurane 1-2% with oxygen was used for maintenance of anesthesia. after stabilization of the patient's hemodynamics and before skin incision erector spinae block or caudal block was performed with the patient in lateral position. after the block patients were flipped back to their normal supine position, surgery took place 10 min after injection of local anesthetic. after termination of surgery reversal of the atracurium was done by giving neostigmine in a dose of 0.04mg/kg and atropine 0.02mg/kg and awake extubation was done
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Erector spinae group | Active comparator | Procedure: erector spinae block - caudal blockthe child received ultrasound-guided erector spinae muscle block in a dose of 0.4mg/kg of 0.25%bupivacaine between the 10th transverse process and erector spinae muscle |
| caudal group | Active comparator | Procedure: erector spinae block - caudal blockchild received ultrasound-guided caudal block in a dose of 2.5mg/kg of bupivacaine 0.25% |
| control | No intervention | –child didn't received any regional block |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- pediatric patients aged 2-6 years scheduled for lower abdominal surgery under general anesthesia
Key exclusion criteria (6 listed)
- parent refusal
- spinal and meningeal anomalies
- mental retardation
- blood disease
- infection at site of injection
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 |
|---|---|---|
| erector spinae block - caudal blockthe child placed in lateral position identification of spinous process of 10th thoracic vertebral then the transducer was moved 2.5 cm laterally to visualize the transverse process and a total of 0.4mg/kg of 0.25%bupivacaine was adminstered | Procedure or surgery | Erector spinae group, caudal group |
Primary outcome
number of patients need rescue analgesia
Time frame: 24 hours
total number of patients need addition of anagesia
2 secondary outcomes
First analgesic request
Time frame: 24 hours
Hemodynamic changes in the study period
Time frame: 24 hours
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 8 Mar 2021.
- Derived from this study: PubMed 35793181Abdelrazik AN, Ibrahim IT, Farghaly AE, Mohamed SR. Ultrasound-guided Erector Spinae Muscle Block Versus Ultrasound-guided Caudal Block in Pediatric Patients Undergoing Lower Abdominal Surgeries. Pain Physician. 2022 Jul;25(4):E571-E580.
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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.
Ibrahim Talaat, MD study director
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 erector spinae block - caudal block in people with Postoperative Analgesia, run by Minia 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 1 inclusion and 6 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 8 Mar 2021. 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?
number of patients need rescue analgesia (time frame: 24 hours). 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 NCT04690894, which also lists 1 linked publication.
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 8 Mar 2021.