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Clinical Trials/NCT05176938
NCT05176938
Unknown
N/A

Effect of Preoperative Ultrasound Guided Thoracic Interfascial Plane Block Versus Preoperative Thoracic Erector Spinae Plane Block on Acute and Chronic Pain After Modified Radical Mastectomy

Tanta University0 sites90 target enrollmentJanuary 10, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain, Acute
Sponsor
Tanta University
Enrollment
90
Primary Endpoint
Total analgesics consumption in the first 24h after surgery.
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 10, 2022
End Date
November 24, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Areeg Kotb Ghalwash

Assistant lecturer of Anesthesiology and Surgical Intensive Care and Pain Medicine

Tanta University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Total analgesics consumption in the first 24h after surgery.

Time Frame: 24 hours postoperative

Total analgesic consumption (fentanyl intraoperative) and (morphine 0.05 mg / kg per dose at the first 24 h after surgery).

Secondary Outcomes

  • Time to first analgesic request after surgery(24 hours Postoperative)
  • Visual Analogue score (VAS)(24 hours Postoperative)
  • Complications occurrence (hypotension, pneumothorax, bradycardia)(24 hours Postoperative)

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