Ignite Creation Date:
2024-07-17 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501079
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-29
Brief Title:
Dexamethasone Versus Mg Added to Bupivacaine Used in ESPB for Perioperative Pain Control in Patients Undergoing Unilateral Nephrectomy
Sponsor:
National Cancer Institute Egypt
Organization:
National Cancer Institute Egypt
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
I Study design
This is a randomized Controlled Study It will involve three groups Control Group C receiving erector spinae block with 27ml bupivacaine 025 3 ml NS Group M receiving 27 ml bupivacaine 025 3 ml magnesium sulphate 10 Group D receiving 27 ml bupivacaine 025 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 02481218 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 micKg Postoperatively NSAIDs such as Ketorolac 30 mg IV infusion if VAS is between 3 to 6 and Morphine 3 mg IV if VAS equals or is more significant than 6
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
I Study design
This is a randomized Controlled Study It will involve three groups Control Group C receiving erector spinae block with 27ml bupivacaine 025 3 ml NS Group M receiving 27 ml bupivacaine 025 3 ml magnesium sulphate 10 Group D receiving 27 ml bupivacaine 025 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 02481218 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 micKg Postoperatively NSAIDs such as Ketorolac 30 mg IV infusion if VAS is between 3 to 6 and Morphine 3 mg IV if VAS equals or is more significant than 6
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None