Effect of Ultrasound Guided Thoracic Interfascial Plane Block Versus Erector Spinae Plane Block After Mastectomy

Not Applicable

• Conditions: Pain, Acute; Mastectomy, Modified Radical; Pain, Chronic; Thoracic Interfascial Plane Block; Erector Spinae Plane Block
• Interventions: Procedure: Ultrasound guided Thoracic Interfascial plane Block (TIFB); Procedure: Ultrasound guided Erector Spinae plane Block (ESPB)

• Registration Number: NCT05176938
• Lead Sponsor: Tanta University

Brief Summary

This study will be conducted to compare the efficacy of ultrasound guided thoracic interfascial plane block versus ultrasound guided erector spinae plane block on acute and chronic pain after modified radical mastectomy surgery.

Detailed Description

Various thoracic nerve blocks performed for pain control after breast cancer surgery provide superior analgesic effect and reduce postoperative nausea and vomiting as a result of the decreased use of opioid analgesics.

Ultrasound-guided erector spinae block (ESB) is a regional anesthesia technique; recently described by Forero et al, in management of thoracic neuropathic pain. It became popular because it is much safer and easily administered than other alternative regional techniques as paravertebral and thoracic epidural block.

ESB leads to effective postoperative analgesia when performed at T 4-5 level for breast and thoracic surgery, and T 7 level for abdominal surgeries. Spread of local anesthetic following ESB in the cephalic and caudal directions can lead to analgesia from C7 to L2-3.

There have been several reports that thoracic interfascial plane block is useful for multimodal analgesia in patients undergoing mastectomy, Thoracic interfascial plane block including pecto-intercostal fascial plane block (PIFB) and serratus intercostal fascial plane block (SIFB).

Thoracic interfascial plane block is the peripheral nerve block that targets the intercostal nerves branches distributed in the chest and axilla, Although PIFB and SIFB are thought to be relatively easy to perform there have been no reports of the simultaneous performance of the two blocks.

Study Timeline

• Study First Submitted: 2021-11-22
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-30
• Last Update Submitted: 2021-12-30
• Study First Posted: 2022-01-04
• Last Update Posted: 2022-01-04
• Study Start: 2022-01-10
• Primary Completion: 2022-11-24
• Study Completion: 2022-11-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• Female patients admitted for modified radical mastectomy surgery.
• American Society of Anesthesiologists (ASA) physical activity I, II
• Aged (18 - 65) years

Exclusion Criteria

• Patient refusal.
• Patient with neurological deficit.
• Patient with bleeding disorders (coagulopathy, thrombocytopenia anticoagulant, and antiplatelet drugs).
• Uncooperative patient.
• Infection at the block injection site.
• Patients with a history of allergy to drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound guided Thoracic Interfascial plane Block (TIFB)	Ultrasound guided Thoracic Interfascial plane Block (TIFB)	Patients will receive (20ml) (plain bupivacaine 0.25% injected in the serratus intercostal space at 6 ribs midaxillary line and (20ml) in pecto-intercostal space at 2 ribs parasternal.
Ultrasound guided Erector Spinae plane Block (ESPB)	Ultrasound guided Erector Spinae plane Block (ESPB)	Patients will receive (20ml) (plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the fourth thoracic segment (T4).

Primary Outcome Measures

Name	Time	Method
Total analgesics consumption in the first 24h after surgery.	24 hours postoperative	Total analgesic consumption (fentanyl intraoperative) and (morphine 0.05 mg / kg per dose at the first 24 h after surgery).

Secondary Outcome Measures

Name	Time	Method
Time to first analgesic request after surgery	24 hours Postoperative	Time to first analgesic request after surgery in the form of intravenous morphine in a dose (0.05 mg/kg) If VAS ≥ 4 all patient will receive paracetamol 1gm /6h.
Visual Analogue score (VAS)	24 hours Postoperative	Pain will be assessed after surgery over 24 hour using VAS score where (0 = no pain and 10 = severe pain) at (T 30 min, 2, 4, 6, 12, 18, 24 h), if less than 4 non-steroidal anti-inflammatory will be given (ketorolac 30mg) and if more than 4 intra venous morphine (0.05mg / kg)
Complications occurrence (hypotension, pneumothorax, bradycardia)	24 hours Postoperative	Adverse events as Bradycardia, hypotension, drowsiness, and dizziness) will be recorded 24 hours Postoperatively.