Ultrasound-guided Thoracic Interfascial Plane Nerve Block Versus Erector Spinae Plane Block for Pain Control After Modified Radical Mastectomy
NCT Number: NCT06548646
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postoperative Pain Following Modified Radical Mastectomy for Breast Cancer
Interventions: PROCEDURE: Thoracic Interfascial Plane Block|PROCEDURE: Erector Spinae Plane Block
Sponsor: Safie ramez tewfeik abd el moneim
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-03-15
Locations: Ainshams University Hospitals, Cairo, Abbasiya, 1181, Egypt

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.

Primary Outcome Measures: Total amount of rescue pain medication required within the first 48 hours after surgery, Researchers will report the total amount of analgesia used in the first 48 hours after surgery, 48 hours
Secondary Outcome Measures: Time to first rescue analgesia', The time at which the first analgesia is adminstered after surgery, 48 hours|Total intraoperative fentanyl consumption, The total intraoperative consumption of fentanyl, Total intraoperative time of surgery|Sleep quality, The postoperative quality of sleep will be evaluated by The Pittsburgh Sleep Quality Index., 48 hours|Time for the first ambulation, The time at which the patient will be first be able to ambulate from bed., 48 hours|VAS score for pain, The postoperative pain using The Visual Analogue Scale (VAS) from 0 to 10, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be)., 48 hours|VAS score for nausea, nausea during the postoperative period using Visual Analogue Scale (VAS) with two endpoints representing 0 ('no nausea') and 10 ('nausea as bad as it could be'), 48 hours|Patient Satisfaction score, (five-point Likert scale) where (1 = extremely dissatisfied to 5 = extremely satisfied) to measure postoperative patient satisfaction., 48 hours