Pain, PostoperativeNCT05543109
Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block
A study testing Fentanyl, Propofol and Rocuronium in people with Pain, Postoperative and Hip Dysplasia, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study was to compare the intraoperative and the postoperative analgesic effect of psoas compartment block (PCB) and supra-inguinal fascia iliaca compartment block (SFIB) in pediatric patients undergoing developmental dysplasia of the hip Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Pain, Postoperative, Hip Dysplasia
- What is being tested?
- Fentanyl, Propofol and Rocuronium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Sep 2022to 10 Feb 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients undergoing undergo acetabuloplasty
- Anesthesiologists (ASA) physical status of I to II
Who cannot join
- Known allergy to local anesthetic
- Infection at the block site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block for Pain Management in Pediatric Patients With Developmental Dysplasia Sia of the Hip Joint, Randomized Controlled Trial
The aim of this study was to compare the intraoperative and the postoperative analgesic effect of psoas compartment block (PCB) and supra-inguinal fascia iliaca compartment block (SFIB) in pediatric patients undergoing developmental dysplasia of the hip
Read the detailed description
All subjects after entering operation room will be connected to standard monitor electrocardiograph, non-invasive blood pressure, heart rate, oxygen saturation.
Three mg/kg of propofol, 0.2 μg/kg of fentanyl and 0.1 mg/kg midazolam will be used for sedation. Oxygen at the concentration of 100% will be administrated under the mask in all patients after satisfactory sedation, tracheal intubation will be performed after intravenous anesthesia with administration of 3 mg/kg of propofol, 0.6 μg/kg of fentanyl and 0.9 mg/kg of rocurium. After intubation 2-3% of sevoflurane and 0.2-0.3 mcg/kg/min of fentanyl will be used to maintain anesthesia guided by PSI and hemodynamic monitoring.
The two groups will receive nerve block with local anesthetics. In the SFIB group, the patients will receive ultrasound-guided SFIB, while the patients in the PCB group will receive PCB under the guidance of ultrasound.
Local anesthetic 0.25% Ropivacaine will be used at 1 ml/kg for SFIB and PCB. (the dose of local anesthetic for SFIB or PCB was not more than 35ml). All blocks will be performed by the same experienced anesthesiologist.
- Conditions
- Pain, Postoperative, Hip Dysplasia
- Being tested
- Fentanyl, Propofol, Rocuronium, Sevoflurane, Ropivacaine
- Medical subject headings
- Pain, Postoperative, Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called Narcotic
1 mic/kg during induction of anesthesia
PropofolDrug
Also called Intravenous anesthetic
3mg/kg during induction of anesthesia
RocuroniumDrug
Also called Muscle relaxant
0.9 mg/kg during induction of anesthesia
SevofluraneDrug
Also called Inhalational anesthetic
2-3% during maintanance of anesthesia
RopivacaineDrug
Also called Local anesthetic
0.25% Ropivacaine will be used at 1 ml/kg will be injected Ultrasound guided after induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Psoas compartment block | Active comparator | After induction of anesthesia; ultrasound guided psoas compartment block will be done using ropivacaine 0.25% 1ml/kg. Receives: Drug: Fentanyl; Drug: Propofol; Drug: Rocuronium; Drug: Sevoflurane; Drug: Ropivacaine |
| Suprainguinal fascia iliaca compartment block | Active comparator | After induction of anesthesia; ultrasound guided suprainguinal fascia iliaca compartment block will be done using ropivacaine 0.25% 1ml/kg. Receives: Drug: Fentanyl; Drug: Propofol; Drug: Rocuronium; Drug: Sevoflurane; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative anesthetic requirement
Intraoperative anesthetic requirement including intraoperative sevoflurane concentration and total fentanyl consumption
Measured: 1 hour
Postoperative analgesic requirements
Postoperative Ketoprofen and morphine consumption
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start29 Sep 2022 (estimated)
- Primary completion10 Feb 2023 (estimated)
- Study completion10 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mohamed Mogahed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543109
- Sponsor's protocol ID
- 35635/8/22
- Status last verified
- Sep 2022
- First submitted
- 13 Sep 2022
- Last updated
- 30 Sep 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 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block for Pain Management in Pediatric Patients With Developmental Dysplasia Sia of the Hip Joint, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05543109
- Acronym / sponsor ID
- 35635/8/22
- Conditions
- Pain, Postoperative, Hip Dysplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 29 Sep 2022 (estimated)
- Primary completion
- 10 Feb 2023 (estimated)
- Study completion
- 10 Feb 2023 (estimated)
- First posted
- 16 Sep 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.
The aim of this study was to compare the intraoperative and the postoperative analgesic effect of psoas compartment block (PCB) and supra-inguinal fascia iliaca compartment block (SFIB) in pediatric patients undergoing developmental dysplasia of the hip
Detailed description
All subjects after entering operation room will be connected to standard monitor electrocardiograph, non-invasive blood pressure, heart rate, oxygen saturation.
Three mg/kg of propofol, 0.2 μg/kg of fentanyl and 0.1 mg/kg midazolam will be used for sedation. Oxygen at the concentration of 100% will be administrated under the mask in all patients after satisfactory sedation, tracheal intubation will be performed after intravenous anesthesia with administration of 3 mg/kg of propofol, 0.6 μg/kg of fentanyl and 0.9 mg/kg of rocurium. After intubation 2-3% of sevoflurane and 0.2-0.3 mcg/kg/min of fentanyl will be used to maintain anesthesia guided by PSI and hemodynamic monitoring.
The two groups will receive nerve block with local anesthetics. In the SFIB group, the patients will receive ultrasound-guided SFIB, while the patients in the PCB group will receive PCB under the guidance of ultrasound.
Local anesthetic 0.25% Ropivacaine will be used at 1 ml/kg for SFIB and PCB. (the dose of local anesthetic for SFIB or PCB was not more than 35ml). All blocks will be performed by the same experienced anesthesiologist.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psoas compartment block | Active comparator | Drug: Fentanyl, Drug: Propofol, Drug: Rocuronium, Drug: Sevoflurane, Drug: RopivacaineAfter induction of anesthesia; ultrasound guided psoas compartment block will be done using ropivacaine 0.25% 1ml/kg. |
| Suprainguinal fascia iliaca compartment block | Active comparator | Drug: Fentanyl, Drug: Propofol, Drug: Rocuronium, Drug: Sevoflurane, Drug: RopivacaineAfter induction of anesthesia; ultrasound guided suprainguinal fascia iliaca compartment block will be done using ropivacaine 0.25% 1ml/kg. |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients undergoing undergo acetabuloplasty
- Anesthesiologists (ASA) physical status of I to II
Key exclusion criteria (2 listed)
- Known allergy to local anesthetic
- Infection at the block 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 |
|---|---|---|
| FentanylAlso: Narcotic1 mic/kg during induction of anesthesia | Drug | Psoas compartment block, Suprainguinal fascia iliaca compartment block |
| PropofolAlso: Intravenous anesthetic3mg/kg during induction of anesthesia | Drug | Psoas compartment block, Suprainguinal fascia iliaca compartment block |
| RocuroniumAlso: Muscle relaxant0.9 mg/kg during induction of anesthesia | Drug | Psoas compartment block, Suprainguinal fascia iliaca compartment block |
| SevofluraneAlso: Inhalational anesthetic2-3% during maintanance of anesthesia | Drug | Psoas compartment block, Suprainguinal fascia iliaca compartment block |
| RopivacaineAlso: Local anesthetic0.25% Ropivacaine will be used at 1 ml/kg will be injected Ultrasound guided after induction of general anesthesia. | Drug | Psoas compartment block, Suprainguinal fascia iliaca compartment block |
Primary outcome
Intraoperative anesthetic requirement
Time frame: 1 hour
Intraoperative anesthetic requirement including intraoperative sevoflurane concentration and total fentanyl consumption
Postoperative analgesic requirements
Time frame: 8 hours
Postoperative Ketoprofen and morphine consumption
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 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.
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 Fentanyl, Propofol and Rocuronium in people with Pain, Postoperative and Hip Dysplasia, 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 30 Sep 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?
Results are not available in the source record.
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?
Intraoperative anesthetic requirement (time frame: 1 hour). The study lists 2 primary outcomes in all. 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 30 Sep 2022.