Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548646
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-04
Brief Title:
Ultrasound-guided Thoracic Interfascial Plane Nerve Block Versus Erector Spinae Plane Block for Pain Control After Modified Radical Mastectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ultrasound-guided Thoracic Interfascial Plane Nerve Block Versus Erector Spinae Plane Block for Postoperative Pain Control in Patients Undergoing Modified Radical Mastectomy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study compares two methods of local pain control in patients undergoing Modified Radical Mastectomy a common surgery for breast cancer tumor in the breast treatment It aims to determine which method the Thoracic Interfascial Plane Block or the Erector Spinae Plane Block provides better pain relief after surgery reduces side effects and increases patient satisfaction
Why This Study Is Important
Breast cancer surgery can cause significant pain and managing this pain is important for a quick recovery Currently pain is often managed with opioids which can cause side effects like nausea and drowsiness invistigators want to find a method that controls pain effectively with fewer side effects helping patients recover faster and feel better
Who Can Take Part
Women aged 21 and older who are scheduled for a Modified Radical Mastectomy at Ain Shams University hospitals can participate in this study
What Will Happen During the Study
Participants will be randomly assigned to receive either the Thoracic Interfascial Plane Block or the Erector Spinae Plane Block before surgery
Pain levels will be measured using a numerical pain score from 1 to 10 Researchers will track the amount of pain medication needed the time it takes to feel pain relief and any side effects
Other factors such as sleep quality time to start walking again and overall satisfaction with pain control will also be recorded
What investigators hope to Learn
Investigators hope to find out which nerve block provides better pain relief after surgery By comparing TIPB and ESPB with the aim to identify the method that
Requires less additional pain medication Has fewer side effects Improves sleep quality and overall recovery Increases patient satisfaction
Significance
This study could lead to better pain management strategies for breast cancer surgery reducing the need for opioids and enhancing patient recovery and comfort
Participation
Participants will be monitored closely during and after the procedure to ensure their safety and well-being The results of this study could help improve pain management for future patients undergoing similar surgeries
Why This Study Is Important
Breast cancer surgery can cause significant pain and managing this pain is important for a quick recovery Currently pain is often managed with opioids which can cause side effects like nausea and drowsiness invistigators want to find a method that controls pain effectively with fewer side effects helping patients recover faster and feel better
Who Can Take Part
Women aged 21 and older who are scheduled for a Modified Radical Mastectomy at Ain Shams University hospitals can participate in this study
What Will Happen During the Study
Participants will be randomly assigned to receive either the Thoracic Interfascial Plane Block or the Erector Spinae Plane Block before surgery
Pain levels will be measured using a numerical pain score from 1 to 10 Researchers will track the amount of pain medication needed the time it takes to feel pain relief and any side effects
Other factors such as sleep quality time to start walking again and overall satisfaction with pain control will also be recorded
What investigators hope to Learn
Investigators hope to find out which nerve block provides better pain relief after surgery By comparing TIPB and ESPB with the aim to identify the method that
Requires less additional pain medication Has fewer side effects Improves sleep quality and overall recovery Increases patient satisfaction
Significance
This study could lead to better pain management strategies for breast cancer surgery reducing the need for opioids and enhancing patient recovery and comfort
Participation
Participants will be monitored closely during and after the procedure to ensure their safety and well-being The results of this study could help improve pain management for future patients undergoing similar surgeries
Detailed Description:
This study is a randomized double-blinded clinical trial comparing the efficacy of two ultrasound-guided nerve blocks for postoperative pain management in patients undergoing Modified Radical Mastectomy MRM The two techniques under investigation are the Thoracic Interfascial Plane Block TIPB and the Erector Spinae Plane Block ESPB Both nerve blocks are administered to provide targeted pain relief by numbing specific nerves involved in the surgical area
Methodology
Participants will be randomly assigned to one of two groups to receive either TIPB or ESPB The randomization will ensure unbiased distribution of participants across both groups The nerve blocks will be administered preoperatively under ultrasound guidance to ensure accurate placement and effectiveness
Assessments and Measurements
Pain levels will be assessed using the Visual Analog Scale VAS at multiple time points postoperatively including at rest and during movement The primary outcome measure is the total amount of rescue pain medication required within the first 48 hours after surgery Secondary outcomes include the time to first rescue analgesic intraoperative fentanyl consumption hemodynamic parameters sleep quality time to first ambulation VAS scores for pain and nausea and overall patient satisfaction
Safety and Monitoring
Participants will be monitored for adverse events including complications related to the nerve block techniques Hemodynamic parameters such as blood pressure and heart rate will be closely observed during the perioperative period to ensure patient safety
Significance
The findings from this study aim to identify a superior pain management strategy that minimizes opioid consumption reduces side effects and enhances recovery and patient satisfaction following MRM If successful the results could inform clinical practice and improve postoperative care for breast cancer patients
This study is conducted at Ain Shams University hospitals and adheres to ethical guidelines to ensure the safety and well-being of all participants
Methodology
Participants will be randomly assigned to one of two groups to receive either TIPB or ESPB The randomization will ensure unbiased distribution of participants across both groups The nerve blocks will be administered preoperatively under ultrasound guidance to ensure accurate placement and effectiveness
Assessments and Measurements
Pain levels will be assessed using the Visual Analog Scale VAS at multiple time points postoperatively including at rest and during movement The primary outcome measure is the total amount of rescue pain medication required within the first 48 hours after surgery Secondary outcomes include the time to first rescue analgesic intraoperative fentanyl consumption hemodynamic parameters sleep quality time to first ambulation VAS scores for pain and nausea and overall patient satisfaction
Safety and Monitoring
Participants will be monitored for adverse events including complications related to the nerve block techniques Hemodynamic parameters such as blood pressure and heart rate will be closely observed during the perioperative period to ensure patient safety
Significance
The findings from this study aim to identify a superior pain management strategy that minimizes opioid consumption reduces side effects and enhances recovery and patient satisfaction following MRM If successful the results could inform clinical practice and improve postoperative care for breast cancer patients
This study is conducted at Ain Shams University hospitals and adheres to ethical guidelines to ensure the safety and well-being of all participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None