Renal DiseaseNCT05890248
Ultrasound Guided Erector Spinae Block Versus Thoracic Para-vertebral Block Versus Quadratus Lamborum Block in Open Renal Surgeries
An observational study of Renal Disease, run by mohamed A Aboelsuod, MD at 1 site in Egypt.
Trial summary
Open renal surgeries are associated with substantial postoperative pain, pain relief in patients undergoing this procedure is usually provided either by thoracic epidural analgesia (EA) or by systemic analgesics. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Disease
- What is being tested?
- Technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 1 Feb 2024
- Phase
- Observational
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This was randomized, controlled, single-blinded study, conducted in urology operating theatre, Al-Azhar university hospital. Forty eight patients of both sex and aged from 21-65 years in period between February 2022 to September 2023 scheduled for elective open renal surgeries under general anesthesia were enrolled in this study. The procedure was explained to the patient and informed consent was signed after his agreement then the patient was classified to one of three groups
Who may be able to join
- Inclusion criteria: Adult patients of both sex, (21-65 years) with renal surgeries with ASA I , II score.
Who cannot join
- Patient's refusal.
- Patients with ASA (III , IV) score.
- Coagulopathy to be cancelled if ( INR>1.4 , Platelets count <100x109 )
- Infection at the injection site.
- Allergy to local anesthetics.
- Patients receiving opioids for chronic analgesic therapy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Azhar University
Cairo, 11765
abdelwahab AS MOHAMED, MD, 0201017733543, ABDELWAHABSALEH@GAMIL.COM
About this study
Open renal surgeries are associated with substantial postoperative pain, pain relief in patients undergoing this procedure is usually provided either by thoracic epidural analgesia (EA) or by systemic analgesics. EA is a very useful option for the management of postoperative pain in patients undergoing abdominal surgeries, but the risks and contraindications linked to EA like hypotension, headache, nerve damage or infection may limit its use. Systemic analgesics in the form of opioid analgesics may give rise to side effects like nausea ,vomiting , constipation , allergy or drowsiness and often provide insufficient analgesia. Hence, other methods of postoperative pain management are desired. Sensory level target according to the incision site Flank (T9-T11) , Thoraco-abdominal (T7-T12 ) and Trans-abdominal (T6-T10). Ultrasound (US) guided erector spinae plane (ESP) block is one of the interfascial plane blocks that target the dorsal and ventral rami of the spinal nerves. Although there is no sufficient evidence for the spread of local anesthetic to the ventral rami, recent reports demonstrated effective postoperative analgesia after thoracic and lumbar surgeries affecting both the ventral and dorsal rami. Paravertebral block (PVB) is a technique where a local anesthetic is deposited into a space found on both sides of the spine, called the paravertebral space. It is a block with a dermatomal distribution of pain relief depending on the level of the spine at which the block is sited and the quantity and type of deposited local anesthetic.
PVB is effective for pain relief in the thoracic, abdominal and limb regions. primary aim was to compare postoperative opioid consumption rates at 24 h. Secondary end points were to compare pain scores and hemodynamic variables.
Read the detailed description
This was randomized, controlled, single-blinded study, conducted in urology operating theatre, Al-Azhar university hospital. Forty eight patients of both sex and aged from 21-65 years in period between February 2022 to January 2023 scheduled for elective open renal surgeries under general anesthesia were enrolled in this study. The procedure was explained to the patient and informed consent was signed after his agreement then the patient was classified to one of three groups
- Conditions
- Renal Disease
- Being tested
- Technique
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TechniqueProcedure or surgery
Also called Paravertebral block versus Erector spinea block versus quadratus lamborum block
Paravertebral block versus Erector spinea block versus quadratus lamborum block
| Study group | Role | What they receive |
|---|---|---|
| Erector spinea block | -ESPB Group (n=12): Received erector spinae plane block. Receives: Procedure: Technique | |
| Thoracic Paravertebral block | TPVB Group (n=12) : Received thoracic paravertebral block. Receives: Procedure: Technique | |
| Control group | Control Group (n=12): Received morphine (0.1 mg/kg iv) before skin incision . | |
| QLB group | Quadratus lamborum block n=12 Receives: Procedure: Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine requirements 24 hours postoperatively
Measured: 24 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start1 Feb 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DiseaseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- mohamed A Aboelsuod, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, mohamed A Aboelsuod, MD, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890248
- Sponsor's protocol ID
- Mohamed A Aboelsuod
- Status last verified
- Jun 2023
- First submitted
- 14 May 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Erector Spinae Block Versus Thoracic Para-vertebral Block Versus Quadratus Lamborum Block in Open Renal Surgeries
- ClinicalTrials.gov ID
- NCT05890248
- Acronym / sponsor ID
- Mohamed A Aboelsuod
- Conditions
- Renal Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- mohamed A Aboelsuod, MDUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 6 Jun 2023 (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.
Open renal surgeries are associated with substantial postoperative pain, pain relief in patients undergoing this procedure is usually provided either by thoracic epidural analgesia (EA) or by systemic analgesics. EA is a very useful option for the management of postoperative pain in patients undergoing abdominal surgeries, but the risks and contraindications linked to EA like hypotension, headache, nerve damage or infection may limit its use. Systemic analgesics in the form of opioid analgesics may give rise to side effects like nausea ,vomiting , constipation , allergy or drowsiness and often provide insufficient analgesia. Hence, other methods of postoperative pain management are desired. Sensory level target according to the incision site Flank (T9-T11) , Thoraco-abdominal (T7-T12 ) and Trans-abdominal (T6-T10). Ultrasound (US) guided erector spinae plane (ESP) block is one of the interfascial plane blocks that target the dorsal and ventral rami of the spinal nerves. Although there is no sufficient evidence for the spread of local anesthetic to the ventral rami, recent reports demonstrated effective postoperative analgesia after thoracic and lumbar surgeries affecting both the ventral and dorsal rami. Paravertebral block (PVB) is a technique where a local anesthetic is deposited into a space found on both sides of the spine, called the paravertebral space. It is a block with a dermatomal distribution of pain relief depending on the level of the spine at which the block is sited and the quantity and type of deposited local anesthetic.
PVB is effective for pain relief in the thoracic, abdominal and limb regions. primary aim was to compare postoperative opioid consumption rates at 24 h. Secondary end points were to compare pain scores and hemodynamic variables.
Detailed description
This was randomized, controlled, single-blinded study, conducted in urology operating theatre, Al-Azhar university hospital. Forty eight patients of both sex and aged from 21-65 years in period between February 2022 to January 2023 scheduled for elective open renal surgeries under general anesthesia were enrolled in this study. The procedure was explained to the patient and informed consent was signed after his agreement then the patient was classified to one of three groups
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Erector spinea block | – | Procedure: Technique-ESPB Group (n=12): Received erector spinae plane block. |
| Thoracic Paravertebral block | – | Procedure: TechniqueTPVB Group (n=12) : Received thoracic paravertebral block. |
| Control group | – | –Control Group (n=12): Received morphine (0.1 mg/kg iv) before skin incision . |
| QLB group | – | Procedure: TechniqueQuadratus lamborum block n=12 |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This was randomized, controlled, single-blinded study, conducted in urology operating theatre, Al-Azhar university hospital. Forty eight patients of both sex and aged from 21-65 years in period between February 2022 to September 2023 scheduled for elective open renal surgeries under general anesthesia were enrolled in this study. The procedure was explained to the patient and informed consent was signed after his agreement then the patient was classified to one of three groups
Key inclusion criteria (1 listed)
- Inclusion criteria: Adult patients of both sex, (21-65 years) with renal surgeries with ASA I , II score.
Key exclusion criteria (6 listed)
- Patient's refusal.
- Patients with ASA (III , IV) score.
- Coagulopathy to be cancelled if ( INR>1.4 , Platelets count <100x109 )
- Infection at the injection site.
- Allergy to local anesthetics.
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 |
|---|---|---|
| TechniqueAlso: Paravertebral block versus Erector spinea block versus quadratus lamborum blockParavertebral block versus Erector spinea block versus quadratus lamborum block | Procedure or surgery | Erector spinea block, QLB group, Thoracic Paravertebral block |
Primary outcome
Total morphine requirements 24 hours postoperatively
Time frame: 24 hours post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Disease, run by mohamed A Aboelsuod, MD 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: status not confirmed, as of the sponsor's last update on 8 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed Aboelsuod, MD (00201091945931 ext. 0402927133, abosoad.mohamed2017@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine requirements 24 hours postoperatively (time frame: 24 hours post operative). 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 8 Jun 2023.