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

NCT ID: NCT06260397

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-28

Study Completion Date

2025-03-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Regional Anesthesia Morbidity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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serratus anterior plane block

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.

Group Type EXPERIMENTAL

serratus anterior plane block

Intervention Type PROCEDURE

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

costotransverse plane block

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

Group Type EXPERIMENTAL

costotransverse block

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

patient controlled analgesia

Intervention Type 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.

Interventions

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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

Intervention Type PROCEDURE

costotransverse block

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

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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AinShamsU

Cairo, Abbasia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Abdalla Ma Abdalla, master

Role: CONTACT

Phone: 00201006717445

Email: [email protected]

Facility Contacts

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Fatma So Elsayed, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 35883207 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35436844 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34907523 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32062870 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33934036 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31668466 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36517403 (View on PubMed)

Other Identifiers

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analgesia for MRM surgeries

Identifier Type: -

Identifier Source: org_study_id