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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • National Cancer institute - Cairo University

    Cairo

    attef, 0225328286, irb@nci.cu.edu.eg

    Ahmed M soliman, lecturer

    Recruiting

Other trials in Egypt

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:

  1. 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 groups in NCT06501079
Study groupRoleWhat they receive
Normal salineActive comparatorreceiving 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 comparatorreceiving 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%
dexamethasoneActive comparatorreceiving 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.

  1. postoperative opioid consumption

    total postoperative rescue analgesia be by Morphine

    Measured: 24 hours post-operatively

Secondary outcomes (3)
  1. 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.

  2. Intraoperative opioid consumption

    total Intraoperative rescue analgesia will be done by giving fentanyl at dose of 1 mic/Kg

    Measured: intraoperative

  3. 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.

  1. First posted15 Jul 2024
  2. Study start1 May 2024
  3. Primary completion1 Nov 2024 (estimated)
  4. Study completion1 Dec 2024 (estimated)

Resources

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)
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

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.

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