Serratus Anterior Plane Block and Costotransverse Block for Analgesia Following Modified Radical Mastectomy Surgeries

Regional Anesthesia Morbidity Clinical Trial

Official title:

Ultrasound Guided Serratus Anterior Plane Block Versus Costotransverse Block on Postoperative Analgesia and Safety Following Modified Radical Mastectomy Surgeries

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06260397
• Other study ID #: analgesia for MRM surgeries
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 28, 2024
• Est. completion date: March 30, 2025

Study information

• Verified date: January 2024
• Source: Ain Shams University
• Contact: Abdalla Magdy Abdalla, master
• Phone: 01002717445
• Email: abdalla.magdy[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Adequate pain management following modified radical mastectomy (MRM) is crucial for early ambulation and patient satisfaction. Breast cancer is the most common malignancy in females, with an increasing incidence in recent years. Surgery is one of the mainstays of therapy for breast cancer, and modified radical mastectomy (MRM) is the most effective and common type of invasive surgical treatment. Post-mastectomy pain syndrome (PMPS) is a surgical complication of breast surgery characterized by chronic neuropathic pain. The aim of this study is to investigate the efficacy and safety of single injection CTB versus SAPB on post-operative acute pain as a part of a multimodal analgesia plan in patients undergoing MRM.

Description:

Patients will be divided randomly by the computer into three groups, group (A): will receive serratus anterior plane block, group (B): will receive costotransverse block and group(C): patient controlled analgesia group (PCA).

Group (A) (SAPB):

SAPB will be performed using an ultrasound machine with a high-frequency linear probe . All patients will be in lateral position to perform the block. At the level of the fourth rib with 45-degree angle, targeting the plane between the latissimus dorsi and serratus muscles, SAPB block will be performed unilaterally on the ipsilateral side of surgery.

Group (B) (CTB):

CTB will be performed using an ultrasound machine with a high-frequency linear probe. All patients will be in lateral position to perform the block. CTB block will be performed unilaterally on the ipsilateral side of surgery at the level of fourth rib.

Group (C) (patient controlled analgesia):

After successful extubation, patients will be transferred to PACU. Patients will receive a bolus dose of 5 mg nalbuphine then PCA pump in the form of 20 mg nalbuphine HCL in 100 ml 0.9% normal saline with basal rate of infusion 5ml/hr with self-administration bolus of 0.5ml with 15 min lock-out time.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: March 30, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. American Society of Anaesthesiologists (ASA) Physical Status Class I, II.

2. Scheduled for modified radical mastectomy (MRM).

3. Body weight ranging from 60 to 100 kilograms.

Exclusion Criteria:

1. Declining to give a written informed consent.

2. History of allergy to the medications used in the study.

3. Contraindications to regional anesthesia (including patient: refusal, coagulopathy, and local infection).

4. Psychiatric disorders.

5. Significant cognitive dysfunction.

6. American Society of Anesthesiologists (ASA) Physical Status Class III and IV.

7. Daily use of opioids.

8. Obesity (BMI > 35 kg/m2).

Related Conditions & MeSH terms

• Regional Anesthesia Morbidity

Intervention

Procedure:
• serratus anterior plane block
using ultrasound, 30 ml of bupivacaine 0.25% will be injected in the plane between the latissimus dorsi and serratus muscles
• costotransverse block
using ultrasound, 30 ml of bupivacaine 0.25% will be injected in the costotransverse plane of fourth rib
• patient controlled analgesia
PCA pump in the form of 20 mg nalbuphine HCL in 100 ml 0.9% normal saline with basal rate of infusion 5ml/hr. with self-administration bolus of 0.5ml with 15 min lock-out time.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

References & Publications (5)

Chappell AG, Bai J, Yuksel S, Ellis MF. Post-Mastectomy Pain Syndrome: Defining Perioperative Etiologies to Guide New Methods of Prevention for Plastic Surgeons. World J Plast Surg. 2020 Sep;9(3):247-253. doi: 10.29252/wjps.9.3.247. — View Citation

Holm UHU, Andersen CHS, Hansen CK, Tanggaard K, Borglum J, Nielsen MV. Ultrasound-guided multiple-injection costotransverse block for mastectomy and primary reconstructive surgery. A study protocol. Acta Anaesthesiol Scand. 2022 Mar;66(3):386-391. doi: 10.1111/aas.14018. Epub 2022 Jan 5. — View Citation

Liu X, Song T, Xu HY, Chen X, Yin P, Zhang J. The serratus anterior plane block for analgesia after thoracic surgery: A meta-analysis of randomized controlled trails. Medicine (Baltimore). 2020 May 22;99(21):e20286. doi: 10.1097/MD.0000000000020286. — View Citation

Shamim Seth U, Perveen S, Ahmed T, Kamal MT, Soomro JA, Murtaza Khomusi M, Kamal M. Postoperative Analgesia in Modified Radical Mastectomy Patients After Instillation of Bupivacaine Through Surgical Drains. Cureus. 2022 Apr 13;14(4):e24125. doi: 10.7759/cureus.24125. eCollection 2022 Apr. — View Citation

Zhao Y, Jin W, Pan P, Feng S, Fu D, Yao J. Ultrasound-guided transversus thoracic muscle plane-pectoral nerve block for postoperative analgesia after modified radical mastectomy: a comparison with the thoracic paravertebral nerve block. Perioper Med (Lond). 2022 Jul 27;11(1):39. doi: 10.1186/s13741-022-00270-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale score at 0,6,12 and 24 hour post-operatively. visual analogue scale is a scale from 0 to 10, 0 represent no pain at all and 10 represent the worst pain	Visual Analogue Scale score will be assessed at both rest and arm elevation	24 hour post-operative
Secondary	The total dose of nalbuphine consumption is used postoperatively per patient rescue analgesia for 24.	dose of nalbuphine consumed by patients	24 hour post-operative