Renal NeoplasmNCT06501079
Dexamethasone Versus Mg Added to Bupivacaine Used in ESPB for Perioperative Pain Control in Patients Undergoing Unilateral Nephrectomy
A study testing ultrasound guided Erector Spinae Plane Block using 27ml bupivacaine 0.25% in people with Renal Neoplasm, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
Aim of the study: The current study aims to compare the effect of adding dexamethasone versus magnesium sulfate to bupivacaine in ultrasound-guided erector spinae plane block on the severity of postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Neoplasm
- What is being tested?
- ultrasound guided Erector Spinae Plane Block using 27ml bupivacaine 0.25%
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 1 Dec 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (18 - 65)
- Patients undergoing unilateral nephrectomy
- ASA II / III
Who cannot join
- Patient refusal
- Age less than 18 years
- Allergy to any of the studied medications
- Mid line incision
- Bilateral nephrectomy
- Distorted anatomy of the back (e.g. kyphoscoliosis)
Show all 9Show fewer
- Known neurologic disorders, psychiatric disorder or chronic pain
- Local infection
- Hemodynamic instability
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
National Cancer institute - Cairo University
Cairo
attef, 0225328286, irb@nci.cu.edu.eg
Ahmed M soliman, lecturer
About this study
Official title: The Efficacy of Dexamethasone Versus Magnesium Sulphate Added to Bupivacaine Used in Erector Spinae Plane Block for Perioperative Pain Control in Patients Undergoing Unilateral Nephrectomy
Aim of the study:
The current study aims to compare the effect of adding dexamethasone versus magnesium sulfate to bupivacaine in ultrasound-guided erector spinae plane block on the severity of postoperative pain.
Primary Objectives:
- To compare the effect of ESPB without additives to the effect of adding dexamethasone and to the impact of adding magnesium sulfate in the form of post-operative morphine consumption
Read the detailed description
Aim of the study:
The current study aims to compare the effect of adding dexamethasone versus magnesium sulfate to bupivacaine in ultrasound-guided erector spinae plane block on the severity of postoperative pain and postoperative morphine consumption.
Methodology:
- Study design:
This is a randomized Controlled Study. It will involve three groups: Control Group (C) receiving erector spinae block with 27ml bupivacaine 0.25% + 3 ml NS, Group (M) receiving 27 ml bupivacaine 0.25% + 3 ml magnesium sulphate 10%, Group (D) receiving 27 ml bupivacaine 0.25% + 8 mg dexamethasone (2 ml) + 1 ml NS.
II. Study setting and location:
National Cancer Institute, Cairo University after approval by the institutional review board.
III. Study population:
Adult patients undergoing unilateral nephrectomy under general anesthesia.
Patients will be randomly assigned to the groups using online random number generator.
Erector Spinae Plane Block technique:
Informed consent, including the risks and benefits of the procedure, should be obtained before carrying out an ESP block. A peri-procedural "timeout" should be performed to confirm the type, side, and location of the procedure and ensure that there are no contraindications.
Standard patient monitoring should be in place, including continuous ECG monitoring, pulse oximetry, and blood pressure measurement in at least 5-minute intervals. Patients should be prepped and draped in sterile conditions. Sterile gloves and surgical cap and a mask are necessary, and the ultrasound probe is placed into the sterile ultrasound probe cover for imaging. The ESP block will be performed at the level of T 10 paraspinal level. The ultrasound transducer should be placed in a cephalocaudal orientation over the midline of the back at the desired level. The probe should then slowly be moved laterally until the transverse process is visible. The transverse process requires differentiation from the rib at that level. The transverse process will be more superficial and wider, while the rib will be deeper and thinner. Erector spinae muscle should be identified superficial to the transverse process. The needle should be inserted superior to the ultrasound probe using an in-plane approach in the cephalad to caudal direction. Once the needle tip is below the erector spinae muscle, a small bolus of local anesthetic should be given through the needle. The erector spinae muscle should be visualized, separating from the transverse process. This separation from the transverse process confirms the proper needle position.
The local anesthetic should then be injected in 5 ml increments, with aspiration after every 5 ml to prevent intravascular injection. Block will be performed preoperatively in the preoperative holding area.
Heart rate and blood pressure to be recorded preoperative, intraoperative and postoperatively
Assessment of pain:
Pain assessment will be done through Visual Analogue Scale. Patients should be informed preoperatively about it and how to use this scale. Starting from recovery time, pain assessment is done by asking the patient to mark the intensity of pain perceived and express it on a 10 cm horizontal scale ranging from no pain at one end to the worst possible pain at the other end.
Assessment of pain is to be done in the recovery unit and at 0,2,4,8,12,18, 24 and 30 hours postoperatively.
Total amount of opioid needed in first 24 hours to be recorded.
Rescue Analgesia:
Intraoperative rescue analgesia will be done by giving fentanyl at dose of 1 mic/Kg. Postoperatively, NSAIDs such as Ketorolac 30 mg I.V infusion if VAS is between 3 to 6, and Morphine 3 mg I.V if VAS equals or is more significant than 6.
- Conditions
- Renal Neoplasm
- Being tested
- ultrasound guided Erector Spinae Plane Block using 27ml bupivacaine 0.25%
- Keywords
- Dexamethasone, Magnesium Sulphate, Bupivacaine, Erector Spinae Plane Block, perioperative, pain control, unilateral nephrectomy
- Medical subject headings
- Kidney Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided Erector Spinae Plane Block using 27ml bupivacaine 0.25%Procedure or surgery
ESP block will be performed U/S at the level of T 10 paraspinal level. The ultrasound transducer should be placed in the midline of the back at the desired level. The probe should then slowly be moved laterally until the transverse process is visible. The transverse process requires differentiation from the rib at that level.
Erector spinae muscle should be identified superficial to the transverse process. The needle inserted superior to the ultrasound probe in the cephalad to caudal direction. Once the needle tip is below the erector spinae muscle.
This separation from the transverse process confirms the proper needlemposition.
The local anesthetic should then be injected in 5 ml increments. The block will be performed preoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Normal saline | Active comparator | receiving erector spinae block with 27ml bupivacaine 0.25% + 3 ml NS Receives: Procedure: ultrasound guided Erector Spinae Plane Block using 27ml bupivacaine 0.25% |
| magnesium sulphate 10% | Active comparator | receiving erector spinae block with 27 ml bupivacaine 0.25% + 3 ml magnesium sulphate 10% Receives: Procedure: ultrasound guided Erector Spinae Plane Block using 27ml bupivacaine 0.25% |
| dexamethasone | Active comparator | receiving erector spinae block with 27 ml bupivacaine 0.25% + 8 mg dexamethasone (2 ml) + 1 ml NS. Receives: Procedure: ultrasound guided Erector Spinae Plane Block using 27ml bupivacaine 0.25% |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative opioid consumption
total postoperative rescue analgesia be by Morphine
Measured: 24 hours post-operatively
Secondary outcomes (3)
time of first rescue analgesia
Ketorolac 30 mg I.V infusion if VAS is between 3 to 6, and Morphine 3 mg I.V if VAS equals or greater than 6
Measured: during 1st 24 postoperatively.
Intraoperative opioid consumption
total Intraoperative rescue analgesia will be done by giving fentanyl at dose of 1 mic/Kg
Measured: intraoperative
visual analogue scale 30 hours post-operatively at rest
visual analogue scale from 0 to 10 as 0 no pain and 10 worst pain
Measured: 24 hours post-operatively at rest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start1 May 2024
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal NeoplasmStudies 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
- The aim of the current study is to compare the effect of adding dexamethasone versus magnesium sulphate to bupivacaine in ultrasound-guided erector spinae plane block on the severity of postoperative pain. Primary Objectives to compare the effect of ESPB without additives to the effect of adding dexamethasone and to the effect of adding magnesium sulphate in the form of post-operative visual analogue scale (VAS) after 30 hours at rest.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Soliman, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501079
- Sponsor's protocol ID
- AP2404-201-004
- Status last verified
- Jul 2024
- First submitted
- 29 Jun 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Till publication
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Dexamethasone Versus Magnesium Sulphate Added to Bupivacaine Used in Erector Spinae Plane Block for Perioperative Pain Control in Patients Undergoing Unilateral Nephrectomy
- ClinicalTrials.gov ID
- NCT06501079
- Acronym / sponsor ID
- AP2404-201-004
- Conditions
- Renal Neoplasm
- Keywords
- Dexamethasone, Magnesium Sulphate, Bupivacaine, Erector Spinae Plane Block, perioperative, pain control, unilateral nephrectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 15 Jul 2024 (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.
Aim of the study:
The current study aims to compare the effect of adding dexamethasone versus magnesium sulfate to bupivacaine in ultrasound-guided erector spinae plane block on the severity of postoperative pain.
Primary Objectives:
- To compare the effect of ESPB without additives to the effect of adding dexamethasone and to the impact of adding magnesium sulfate in the form of post-operative morphine consumption
Detailed description
Aim of the study:
The current study aims to compare the effect of adding dexamethasone versus magnesium sulfate to bupivacaine in ultrasound-guided erector spinae plane block on the severity of postoperative pain and postoperative morphine consumption.
Methodology:
- Study design:
This is a randomized Controlled Study. It will involve three groups: Control Group (C) receiving erector spinae block with 27ml bupivacaine 0.25% + 3 ml NS, Group (M) receiving 27 ml bupivacaine 0.25% + 3 ml magnesium sulphate 10%, Group (D) receiving 27 ml bupivacaine 0.25% + 8 mg dexamethasone (2 ml) + 1 ml NS.
II. Study setting and location:
National Cancer Institute, Cairo University after approval by the institutional review board.
III. Study population:
Adult patients undergoing unilateral nephrectomy under general anesthesia.
Patients will be randomly assigned to the groups using online random number generator.
Erector Spinae Plane Block technique:
Informed consent, including the risks and benefits of the procedure, should be obtained before carrying out an ESP block. A peri-procedural "timeout" should be performed to confirm the type, side, and location of the procedure and ensure that there are no contraindications.
Standard patient monitoring should be in place, including continuous ECG monitoring, pulse oximetry, and blood pressure measurement in at least 5-minute intervals. Patients should be prepped and draped in sterile conditions. Sterile gloves and surgical cap and a mask are necessary, and the ultrasound probe is placed into the sterile ultrasound probe cover for imaging. The ESP block will be performed at the level of T 10 paraspinal level. The ultrasound transducer should be placed in a cephalocaudal orientation over the midline of the back at the desired level. The probe should then slowly be moved laterally until the transverse process is visible. The transverse process requires differentiation from the rib at that level. The transverse process will be more superficial and wider, while the rib will be deeper and thinner. Erector spinae muscle should be identified superficial to the transverse process. The needle should be inserted superior to the ultrasound probe using an in-plane approach in the cephalad to caudal direction. Once the needle tip is below the erector spinae muscle, a small bolus of local anesthetic should be given through the needle. The erector spinae muscle should be visualized, separating from the transverse process. This separation from the transverse process confirms the proper needle position.
The local anesthetic should then be injected in 5 ml increments, with aspiration after every 5 ml to prevent intravascular injection. Block will be performed preoperatively in the preoperative holding area.
Heart rate and blood pressure to be recorded preoperative, intraoperative and postoperatively
Assessment of pain:
Pain assessment will be done through Visual Analogue Scale. Patients should be informed preoperatively about it and how to use this scale. Starting from recovery time, pain assessment is done by asking the patient to mark the intensity of pain perceived and express it on a 10 cm horizontal scale ranging from no pain at one end to the worst possible pain at the other end.
Assessment of pain is to be done in the recovery unit and at 0,2,4,8,12,18, 24 and 30 hours postoperatively.
Total amount of opioid needed in first 24 hours to be recorded.
Rescue Analgesia:
Intraoperative rescue analgesia will be done by giving fentanyl at dose of 1 mic/Kg. Postoperatively, NSAIDs such as Ketorolac 30 mg I.V infusion if VAS is between 3 to 6, and Morphine 3 mg I.V if VAS equals or is more significant than 6.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- The aim of the current study is to compare the effect of adding dexamethasone versus magnesium sulphate to bupivacaine in ultrasound-guided erector spinae plane block on the severity of postoperative pain. Primary Objectives to compare the effect of ESPB without additives to the effect of adding dexamethasone and to the effect of adding magnesium sulphate in the form of post-operative visual analogue scale (VAS) after 30 hours at rest.
| Arm | Type | Receives |
|---|---|---|
| Normal saline | Active comparator | Procedure: ultrasound guided Erector Spinae Plane Block using 27ml bupivacaine 0.25%receiving erector spinae block with 27ml bupivacaine 0.25% + 3 ml NS |
| magnesium sulphate 10% | Active comparator | Procedure: ultrasound guided Erector Spinae Plane Block using 27ml bupivacaine 0.25%receiving erector spinae block with 27 ml bupivacaine 0.25% + 3 ml magnesium sulphate 10% |
| dexamethasone | Active comparator | Procedure: ultrasound guided Erector Spinae Plane Block using 27ml bupivacaine 0.25%receiving erector spinae block with 27 ml bupivacaine 0.25% + 8 mg dexamethasone (2 ml) + 1 ml NS. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (18 - 65)
- Patients undergoing unilateral nephrectomy
- ASA II / III
Key exclusion criteria (9 listed)
- Patient refusal
- Age less than 18 years
- Allergy to any of the studied medications
- Mid line incision
- Bilateral nephrectomy
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 |
|---|---|---|
| ultrasound guided Erector Spinae Plane Block using 27ml bupivacaine 0.25%ESP block will be performed U/S at the level of T 10 paraspinal level. The ultrasound transducer should be placed in the midline of the back at the desired level. The probe should then slowly be moved laterally until the transverse process is visible. The transverse process requires differentiation from the rib at that level. Erector spinae muscle should be identified superficial to the transverse process. The needle inserted superior to the ultrasound probe in the cephalad to caudal direction. Once the needle tip is below the erector spinae muscle. This separation from the transverse process confirms the proper needlemposition. The local anesthetic should then be injected in 5 ml increments. The block will be performed preoperatively. | Procedure or surgery | Normal saline, dexamethasone, magnesium sulphate 10% |
Primary outcome
postoperative opioid consumption
Time frame: 24 hours post-operatively
total postoperative rescue analgesia be by Morphine
3 secondary outcomes
time of first rescue analgesia
Time frame: during 1st 24 postoperatively.
Intraoperative opioid consumption
Time frame: intraoperative
visual analogue scale 30 hours post-operatively at rest
Time frame: 24 hours post-operatively at rest
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Individual participant dataSharing planned: Undecided. Till publication
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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?
A study testing ultrasound guided Erector Spinae Plane Block using 27ml bupivacaine 0.25% in people with Renal Neoplasm, run by National Cancer Institute, Egypt 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 3 inclusion and 9 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 15 Jul 2024. 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 Ahmed M Soliman (01286979695, ams21787arif@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative opioid consumption (time frame: 24 hours post-operatively). 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 15 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.