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

NCT06260397 | Unknown DMC

• 1 other identifier: analgesia for MRM surgeries
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Regional Anesthesia Morbidity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The total dose of nalbuphine consumption is used postoperatively per patient rescue analgesia for 24.

  24 hour post-operative

• Incidence of chronic pain after 6 months of surgery

  6 months after surgery

Study Arms (3)

serratus anterior plane block

EXPERIMENTAL

while the patients in lateral position, serratus anterior plane block will be done using high frequency linear ultrasound probe at the level of fourth rib.30 ml of 0.25% bupivacaine will be injected.

Procedure: serratus anterior plane block

costotransverse plane block

EXPERIMENTAL

while the patients in lateral position, costotransverse block will be done using 22-gauge echogenic needle. the needle is advanced in-plane lateral to the spinous process of the 4th thoracic vertebra from caudally cephalad.30 ml of 0.25% bupivacaine will be injected

Procedure: costotransverse block

patient controlled analgesia

EXPERIMENTAL

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.

Procedure: patient controlled analgesia

Interventions

serratus anterior plane block PROCEDURE

using ultrasound, 30 ml of bupivacaine 0.25% will be injected in the plane between the latissimus dorsi and serratus muscles

serratus anterior plane block

costotransverse block PROCEDURE

using ultrasound, 30 ml of bupivacaine 0.25% will be injected in the costotransverse plane of fourth rib

costotransverse plane block

patient controlled analgesia PROCEDURE

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.

patient controlled analgesia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anaesthesiologists (ASA) Physical Status Class I, II.
• Scheduled for modified radical mastectomy (MRM).
• Body weight ranging from 60 to 100 kilograms.

You may not qualify if:

• Declining to give a written informed consent.
• History of allergy to the medications used in the study.
• Contraindications to regional anesthesia (including patient: refusal, coagulopathy, and local infection).
• Psychiatric disorders.
• Significant cognitive dysfunction.
• American Society of Anesthesiologists (ASA) Physical Status Class III and IV.
• Daily use of opioids.
• Obesity (BMI \> 35 kg/m2).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

AinShamsU

Cairo, Abbasia, 154411, Egypt

RECRUITING

Related Publications (7)

• 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.

  PMID: 35883207 BACKGROUND

• Aygun H, Kiziloglu I, Ozturk NK, Ocal H, Inal A, Kutlucan L, Gonullu E, Tulgar S. Use of ultrasound guided single shot costotransverse block (intertransverse process) in breast cancer surgery: a prospective, randomized, assessor blinded, controlled clinical trial. BMC Anesthesiol. 2022 Apr 18;22(1):110. doi: 10.1186/s12871-022-01651-3.

  PMID: 35436844 BACKGROUND

• 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.

  PMID: 34907523 BACKGROUND

• Jack JM, McLellan E, Versyck B, Englesakis MF, Chin KJ. The role of serratus anterior plane and pectoral nerves blocks in cardiac surgery, thoracic surgery and trauma: a qualitative systematic review. Anaesthesia. 2020 Oct;75(10):1372-1385. doi: 10.1111/anae.15000. Epub 2020 Feb 16.

  PMID: 32062870 BACKGROUND

• Sahin A, Baran O, Gultekin A, Yildirim I, Arar C, Gunkaya M. Serratus anterior plane block for tertiary revision rhinoplasty with rib cartilage harvest. J Clin Anesth. 2021 Oct;73:110292. doi: 10.1016/j.jclinane.2021.110292. Epub 2021 Apr 29. No abstract available.

  PMID: 33934036 BACKGROUND

• Ohgoshi Y, Usui Y, Ando A, Takeda Y, Ohtsuka A. Injection at the costotransverse notch facilitates paravertebral spread of the erector spinae plane block: A cadaveric study. J Clin Anesth. 2020 May;61:109630. doi: 10.1016/j.jclinane.2019.109630. Epub 2019 Oct 23. No abstract available.

  PMID: 31668466 BACKGROUND

• Wang Y, Shi M, Huang S, He X, Gu X, Ma Z. Ultrasound-guided serratus anterior plane block versus paravertebral block on postoperation analgesia and safety following the video-assisted thoracic surgery: A prospective, randomized, double-blinded non-inferiority clinical trial. Asian J Surg. 2023 Oct;46(10):4215-4221. doi: 10.1016/j.asjsur.2022.11.125. Epub 2022 Dec 12.

  PMID: 36517403 BACKGROUND

MeSH Terms

Interventions

Analgesia, Patient-Controlled

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Central Study Contacts

Abdalla Ma Abdalla, master

CONTACT

00201006717445; abdalla.magdy@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: December 28, 2023
• Primary Completion: February 28, 2025
• Study Completion: March 30, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)