Clinical trial NCT06548646: Ultrasound-guided Thoracic Interfascial Plane Nerve Block Versus Erector Spinae Plane Block for Pain Control After Modified Radical Mastectomy
Official title: Ultrasound-guided Thoracic Interfascial Plane Nerve Block Versus Erector Spinae Plane Block for Postoperative Pain Control in Patients Undergoing Modified Radical Mastectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain Following Modified Radical Mastectomy for Breast Cancer
Keywords: breast cancer
Modified Radical Mastectomy
Mastectomy
postoperative pain
Erector Spinae Plane Block
Thoracic Interfascial Plane Block
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 50
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Female patients older than 21 years old
* American Society of Anesthesiologists (ASA) physical status II.

Exclusion Criteria:

* Known allergy to one of the study\&#39;s medications.
* Skin infections at the site of the needle puncture.
* Significant organ dysfunction (hepatic, renal, or cardiac dysfunction), coagulopathy or recent anticoagulant use, epilepsy.
* Patients diagnosed with obstructive sleep apnoea, pulmonary compromise .

Primary outcomes:
measure: Total amount of rescue pain medication required within the first 48 hours after surgery
timeFrame: 48 hours
Secondary outcomes:
measure: Time to first rescue analgesia'
timeFrame: 48 hours
measure: Total intraoperative fentanyl consumption
timeFrame: Total intraoperative time of surgery
measure: Sleep quality
timeFrame: 48 hours
measure: Time for the first ambulation
timeFrame: 48 hours
measure: VAS score for pain
timeFrame: 48 hours
measure: VAS score for nausea
timeFrame: 48 hours
measure: Patient Satisfaction score
timeFrame: 48 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ainshams University Hospitals
state: Abbasiya
Study officials:
References:
citation: Kaur U, Shamshery C, Agarwal A, Prakash N, Valiveru RC, Mishra P. Evaluation of postoperative pain in patients undergoing modified radical mastectomy with pectoralis or serratus-intercostal fascial plane blocks. Korean J Anesthesiol. 2020 Oct;73(5):425-433. doi: 10.4097/kja.20159. Epub 2020 Sep 24.
citation: Hong B, Yoon SH, Youn AM, Kim BJ, Song S, Yoon Y. Thoracic interfascial nerve block for breast surgery in a pregnant woman: a case report. Korean J Anesthesiol. 2017 Apr;70(2):209-212. doi: 10.4097/kjae.2017.70.2.209. Epub 2017 Jan 12.
citation: Zhang H, Miao Y, Qu Z. Refining a great idea: the consolidation of PECS I, PECS II and serratus blocks into a single thoracic fascial plane block, the SAP block-a concern on the muscle pain. Reg Anesth Pain Med. 2020 Jun;45(6):480. doi: 10.1136/rapm-2019-101042. Epub 2019 Oct 25. No abstract available.
citation: Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
citation: Boogaerts JG, Vanacker E, Seidel L, Albert A, Bardiau FM. Assessment of postoperative nausea using a visual analogue scale. Acta Anaesthesiol Scand. 2000 Apr;44(4):470-4. doi: 10.1034/j.1399-6576.2000.440420.x.