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

NCT ID: NCT05176938

Last Updated: 2022-01-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2022-11-24

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ultrasound guided Thoracic Interfascial plane Block (TIFB)

Intervention Type: 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 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).

Group Type: EXPERIMENTAL

Ultrasound guided Erector Spinae plane Block (ESPB)

Intervention Type: 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.

General anesthesia

Patients will receive general anesthesia only without blocks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ultrasound guided Thoracic Interfascial plane Block (TIFB)

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.

Intervention Type: PROCEDURE

Ultrasound guided Erector Spinae plane Block (ESPB)

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Areeg Kotb Ghalwash

Assistant lecturer of Anesthesiology and Surgical Intensive Care and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Areeg K. Ghalwash, MD

Role: CONTACT

Areg.kotb@med.tanta.edu.eg

1020103170 ext. +20

Other Identifiers

33645/1/20

Identifier Type: -

Identifier Source: org_study_id