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

NCT05176938 | Unknown

• 1 other identifier: 33645/1/20
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain, Acute; Erector Spinae Plane Block; Mastectomy, Modified Radical; Thoracic Interfascial Plane Block; Pain, Chronic

Outcome Measures

Primary Outcomes (1)

• Total analgesics consumption in the first 24h after surgery.

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

  24 hours postoperative

Secondary Outcomes (3)

• 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

Study Arms (3)

Ultrasound guided Thoracic Interfascial plane Block (TIFB)

EXPERIMENTAL

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.

Procedure: Ultrasound guided Thoracic Interfascial plane Block (TIFB)

Ultrasound guided Erector Spinae plane Block (ESPB)

EXPERIMENTAL

Patients will receive (20ml) (plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the fourth thoracic segment (T4).

Procedure: Ultrasound guided Erector Spinae plane Block (ESPB)

General anesthesia

NO INTERVENTION

Patients will receive general anesthesia only without blocks.

Interventions

Ultrasound guided Thoracic Interfascial plane Block (TIFB) PROCEDURE

Patients of the group will be placed supine and elevate arm to the head, Serratus intercostal plane block will be with the probe in the midaxillary line, The subcutaneous tissue and serratus muscle will be identified in the superficial plane, whereas the external intercostal muscles will be identified in the intermediate plane and finally in the deep plane the ribs, pleura and lung will be identified. The needle will be advanced from caudal to cranial direction after giving 3 ml lidocaine locally. In-plane technique was used until the tip of the needle placed between the serratus anterior muscle and the external intercostals muscle a volume of 20 ml plain bupivacaine will be injected.

Ultrasound guided Thoracic Interfascial plane Block (TIFB)

Ultrasound guided Erector Spinae plane Block (ESPB) PROCEDURE

The patient will be placed in setting position and a superficial (5-12 MHz) ultrasound transducer will be placed in a longitudinal orientation, 3 cm lateral to the T4 spinous process. An 8-cm 22-gauge spinal needle will be inserted in cephalic direction after giving 3 ml lidocaine locally until the needle tip hit the transverse process of T4 under ultrasound image visualization, then the needle will be withdrawn slowly to be within the interfacial plane below the erector spinae muscle, then the anesthetic mixture will be injected here. Successful injection will be evidenced by visible linear free spread (cranially and caudally) of injectate below the muscle.

Ultrasound guided Erector Spinae plane Block (ESPB)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

MeSH Terms

Conditions

Acute Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Areeg K. Ghalwash, MD

CONTACT

1020103170; Areg.kotb@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Anesthesiology and Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: January 4, 2022
• Study Start: January 10, 2022
• Primary Completion: November 24, 2022
• Study Completion: November 24, 2022
• Last Updated: January 4, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: one year after the end of the study