Postoperative PainNCT04374396
Erector Spinea Plane Block in Pediatric Hip Surgery
A study testing Real ultrasound-guided single shot erector spinae plane block (ESP B) in people with Postoperative Pain and Opioid Use, run by Tanta University at 1 site in Egypt.
Trial summary
This prospective randomized controlled double-blind study will be carried out to evaluate the effect of ultrasound-guided erector spinae plane block on the postoperative analgesia in children after hip surgeries, the total morphine consumption in the first postoperative day will be the primary outcome and the time to… Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Postoperative Pain, Opioid Use
- What is being tested?
- Real ultrasound-guided single shot erector spinae plane block (ESP B)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jul 2020to 2 Feb 2021
- 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 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 1-5 years old, of both sexes, American Society of Anesthesiologists (ASA) physical status class I-II and scheduled for surgical treatment of hip disorder under general anesthesia will be included in this study
Who cannot join
- Parental refusal.
- Preexisting spinal deformity or profound mental retardation.
- Obese Children
- Known or suspected allergy to local anesthetics.
- Known or suspected coagulopathy
- Major cardiac, renal, or hepatic disorders.
- Children undergoing combined or bilateral surgeries.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Erector Spinea Plane Block on the Postoperative Analgesia in Pediatric Hip Surgery: Randomized Controlled Study
This prospective randomized controlled double-blind study will be carried out to evaluate the effect of ultrasound-guided erector spinae plane block on the postoperative analgesia in children after hip surgeries, the total morphine consumption in the first postoperative day will be the primary outcome and the time to first request for rescue analgesia and postoperative pain score will be the secondary outcome.
The study will be carried out on pediatric patients undergoing hip surgery where they will receive real or sham ultrasound guided erector spinae plane block before the onset of the surgery.
Read the detailed description
This prospective randomized controlled double-blind study will be carried out to evaluate the effect of ultrasound-guided erector spinae plane block on the postoperative analgesia in children after hip surgeries.
Primary outcome: Total morphine consumption in the first postoperative day. Secondary outcome: The time to first request for rescue analgesia and postoperative pain score.
This clinical trial will be carried out in Tanta University Hospitals for a period of 6 month that may be extended on pediatric patients scheduled for surgical treatment of hip disorder under general anesthesia.
A written informed consent will be obtained from the parents of all patients. Randomization will be performed by an independent data manager assigned the patients to groups based on a computer-generated randomization program introduced in closed opaque envelope.
Group 1 (20 patients): patients in this group will receive sham ipsilateral ultrasound-guided single shot erector spinae block at the level of second lumbar vertebra after induction of anesthesia and before the start of surgery without injection of local anesthetics.
Group 2 (20 patients): patients in this group will receive real ipsilateral ultrasound-guided single shot erector spinae block att the level of second lumbar vertebra after induction of anesthesia and before the start of surgery with injection of 0.3 ml/kg of 0.25% of plain bupivacaine.
Anesthetic technique All the patients will be adequately assessed preoperatively in the anesthesia clinic through history taking, general and local examination, and requesting investigation. Adequate explanation of the procedure, benefit, and potential hazards will be done to the parents with final reassurance of them. All children will receive sedation in the form of oral midazolam 0.5 mg/kg 15 minutes before admission to the operating room.
Upon admission to the operating room, intravascular access will be obtained with starting i.v infusion of Dextrose 5% in normal saline (7 ml/kg). Then, the patients will be attached to a monitor of pulse oximetry, non-invasive blood pressure, end-tidal carbon dioxide, temperature, and 5 leads electrocardiogram. Induction of anesthesia will be carried out using sevoflurane 6% in oxygen: air (4:1) till the child loss the consciousness, then, fentanyl 0.5 ug/kg will be given intravenously and atracurium 0.5 mg/kg will be given intravenously to facilitate endotracheal intubation. A suitable sized endotracheal tube will be introduced and secured with connection of the patients to a mechanical ventilator (pressure-controlled mode) which parameters will be adjusted to maintain end-tidal carbon dioxide 36-40 mmHg.
Anesthesia will be maintained by sevoflurane (1 MAC) with incremental doses of atracurium. Also, incremental doses of fentanyl 0.5 ug/kg will be given i.v in case of increase bispectral index (BIS) more than 60 or by increase in the heart rate or the mean arterial pressure by more than 20% of the baseline values.
- Conditions
- Postoperative Pain, Opioid Use
- Being tested
- Real ultrasound-guided single shot erector spinae plane block (ESP B), Sham ultrasound-guided single shot erector spinae plane block (ESP B)
- Keywords
- Erecto spinae plane, Hip surgery, Children, Pain, Morphine consumption
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real ultrasound-guided single shot erector spinae plane block (ESP B)Procedure or surgery
ESP block will be performed with the patient lying in the lateral position and the surgical side at the top. After skin disinfection, sterile draping will be placed, and ultrasound probe will be sheathed. The level of the block will be at the transverse process of L2, using a 9-12 MHz linear probe and placed in a parasagittal plane 1 cm from the posterior midline. The deep plane to the erector spinae muscle (ESM) will be identified and a 22 Gauge 50 mm insulated needle will be inserted craniocaudally in plane between the transverse process and the fascia of the ESM.
After negative aspiration, 0.3 mL/kg- of bupivacaine 0.25% will be injected confirming correct position by visualizing the solution lifting the ESM off the transverse process .Spread of LA between the L1 and L4 transverse processes will be thereafter visually tracked with the transducer. In the control group, no local anesthetics will be injected.
Sham ultrasound-guided single shot erector spinae plane block (ESP B)Radiation
EESP block will be performed with the patient lying in the lateral position and the surgical side at the top. After skin disinfection, sterile draping will be placed, and ultrasound probe will be sheathed. The level of the block will be at the transverse process of L2, using a 9-12 MHz linear probe and placed in a parasagittal plane 1 cm from the posterior midline. The deep plane to the erector spinae muscle (ESM) will be identified and a 22 Gauge 50 mm insulated needle will be inserted craniocaudally in plane between the transverse process and the fascia of the ESM.
No local anesthetics will be injected
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Sham comparator | patients in this group will receive sham ipsilateral ultrasound-guided single shot erector spinae block at L2 after induction of anaesthesia and before the start of surgery without injection of local anesthetics Receives: Radiation: Sham ultrasound-guided single shot erector spinae plane block (ESP B) |
| Group 2 | Experimental | patients in this group will receive real ipsilateral ultrasound-guided single shot erector spinae block at L2 after induction of anaesthesia and before the start of surgery with injection of 0.3 ml/kg of 0.25% of plain bupivacaine. Receives: Procedure: Real ultrasound-guided single shot erector spinae plane block (ESP B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption in the first postoperative day
Calculation of the total dose of morphine consumed in the first day after surgery
Measured: The first 24 hours after surgery
Secondary outcomes (2)
The time to first request for rescue analgesia
The time interval from the end of the surgery till the first dose of morphine administrated
Measured: The first 24 hours after surgery
Postoperative pain score
The postoperative pain score (CHEOPS pain score)
Measured: every 2 hours in the first 8 hours then every 4 hours till 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start28 Jul 2020
- Primary completion1 Feb 2021
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment Prospective study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Abdelkhalik Ahmed Ismaiel, Tanta University
- Investigators
- Sameh Ismaiel, M.D, Study director, Lecturer of Anesthesia and Intensive Care, Tanta UniversityMohamed Abdullah, M.D, Study director, Assistant Professor of Anesthesia and Intensive Care, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374396
- Sponsor's protocol ID
- 33779/4/20
- Status last verified
- Feb 2021
- First submitted
- 1 May 2020
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Once the study had been successfully completed, the data will be shared for other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Erector Spinea Plane Block on the Postoperative Analgesia in Pediatric Hip Surgery: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04374396
- Acronym / sponsor ID
- 33779/4/20
- Conditions
- Postoperative Pain, Opioid Use
- Keywords
- Erecto spinae plane, Hip surgery, Children, Pain, Morphine consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 5 May 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 controlled double-blind study will be carried out to evaluate the effect of ultrasound-guided erector spinae plane block on the postoperative analgesia in children after hip surgeries, the total morphine consumption in the first postoperative day will be the primary outcome and the time to first request for rescue analgesia and postoperative pain score will be the secondary outcome.
The study will be carried out on pediatric patients undergoing hip surgery where they will receive real or sham ultrasound guided erector spinae plane block before the onset of the surgery.
Detailed description
This prospective randomized controlled double-blind study will be carried out to evaluate the effect of ultrasound-guided erector spinae plane block on the postoperative analgesia in children after hip surgeries.
Primary outcome: Total morphine consumption in the first postoperative day. Secondary outcome: The time to first request for rescue analgesia and postoperative pain score.
This clinical trial will be carried out in Tanta University Hospitals for a period of 6 month that may be extended on pediatric patients scheduled for surgical treatment of hip disorder under general anesthesia.
A written informed consent will be obtained from the parents of all patients. Randomization will be performed by an independent data manager assigned the patients to groups based on a computer-generated randomization program introduced in closed opaque envelope.
Group 1 (20 patients): patients in this group will receive sham ipsilateral ultrasound-guided single shot erector spinae block at the level of second lumbar vertebra after induction of anesthesia and before the start of surgery without injection of local anesthetics.
Group 2 (20 patients): patients in this group will receive real ipsilateral ultrasound-guided single shot erector spinae block att the level of second lumbar vertebra after induction of anesthesia and before the start of surgery with injection of 0.3 ml/kg of 0.25% of plain bupivacaine.
Anesthetic technique All the patients will be adequately assessed preoperatively in the anesthesia clinic through history taking, general and local examination, and requesting investigation. Adequate explanation of the procedure, benefit, and potential hazards will be done to the parents with final reassurance of them. All children will receive sedation in the form of oral midazolam 0.5 mg/kg 15 minutes before admission to the operating room.
Upon admission to the operating room, intravascular access will be obtained with starting i.v infusion of Dextrose 5% in normal saline (7 ml/kg). Then, the patients will be attached to a monitor of pulse oximetry, non-invasive blood pressure, end-tidal carbon dioxide, temperature, and 5 leads electrocardiogram. Induction of anesthesia will be carried out using sevoflurane 6% in oxygen: air (4:1) till the child loss the consciousness, then, fentanyl 0.5 ug/kg will be given intravenously and atracurium 0.5 mg/kg will be given intravenously to facilitate endotracheal intubation. A suitable sized endotracheal tube will be introduced and secured with connection of the patients to a mechanical ventilator (pressure-controlled mode) which parameters will be adjusted to maintain end-tidal carbon dioxide 36-40 mmHg.
Anesthesia will be maintained by sevoflurane (1 MAC) with incremental doses of atracurium. Also, incremental doses of fentanyl 0.5 ug/kg will be given i.v in case of increase bispectral index (BIS) more than 60 or by increase in the heart rate or the mean arterial pressure by more than 20% of the baseline values.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment Prospective study
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Sham comparator | Radiation: Sham ultrasound-guided single shot erector spinae plane block (ESP B)patients in this group will receive sham ipsilateral ultrasound-guided single shot erector spinae block at L2 after induction of anaesthesia and before the start of surgery without injection of local anesthetics |
| Group 2 | Experimental | Procedure: Real ultrasound-guided single shot erector spinae plane block (ESP B)patients in this group will receive real ipsilateral ultrasound-guided single shot erector spinae block at L2 after induction of anaesthesia and before the start of surgery with injection of 0.3 ml/kg of 0.25% of plain bupivacaine. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged between 1-5 years old, of both sexes, American Society of Anesthesiologists (ASA) physical status class I-II and scheduled for surgical treatment of hip disorder under general anesthesia will be included in this study
Key exclusion criteria (7 listed)
- Parental refusal.
- Preexisting spinal deformity or profound mental retardation.
- Obese Children
- Known or suspected allergy to local anesthetics.
- Known or suspected coagulopathy
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 |
|---|---|---|
| Real ultrasound-guided single shot erector spinae plane block (ESP B)ESP block will be performed with the patient lying in the lateral position and the surgical side at the top. After skin disinfection, sterile draping will be placed, and ultrasound probe will be sheathed. The level of the block will be at the transverse process of L2, using a 9-12 MHz linear probe and placed in a parasagittal plane 1 cm from the posterior midline. The deep plane to the erector spinae muscle (ESM) will be identified and a 22 Gauge 50 mm insulated needle will be inserted craniocaudally in plane between the transverse process and the fascia of the ESM. After negative aspiration, 0.3 mL/kg- of bupivacaine 0.25% will be injected confirming correct position by visualizing the solution lifting the ESM off the transverse process .Spread of LA between the L1 and L4 transverse processes will be thereafter visually tracked with the transducer. In the control group, no local anesthetics will be injected. | Procedure or surgery | Group 2 |
| Sham ultrasound-guided single shot erector spinae plane block (ESP B)EESP block will be performed with the patient lying in the lateral position and the surgical side at the top. After skin disinfection, sterile draping will be placed, and ultrasound probe will be sheathed. The level of the block will be at the transverse process of L2, using a 9-12 MHz linear probe and placed in a parasagittal plane 1 cm from the posterior midline. The deep plane to the erector spinae muscle (ESM) will be identified and a 22 Gauge 50 mm insulated needle will be inserted craniocaudally in plane between the transverse process and the fascia of the ESM. No local anesthetics will be injected | Radiation | Group 1 |
Primary outcome
Total morphine consumption in the first postoperative day
Time frame: The first 24 hours after surgery
Calculation of the total dose of morphine consumed in the first day after surgery
2 secondary outcomes
The time to first request for rescue analgesia
Time frame: The first 24 hours after surgery
Postoperative pain score
Time frame: every 2 hours in the first 8 hours then every 4 hours till 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 5 Feb 2021.
- Individual participant dataSharing planned: No. Once the study had been successfully completed, the data will be shared for other researchers.
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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 Ismaiel, M.D study director
Lecturer of Anesthesia and Intensive Care, Tanta University
Mohamed Abdullah, M.D study director
Assistant Professor of Anesthesia and Intensive Care, Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real ultrasound-guided single shot erector spinae plane block (ESP B) in people with Postoperative Pain and Opioid Use, run by Tanta 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 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 5 Feb 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. Some participants in this study may receive a placebo. 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?
Total morphine consumption in the first postoperative day (time frame: The first 24 hours after surgery). 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 5 Feb 2021.