Comparison of Analgesic Efficacy of Ultrasound Guided Rhomboid Intercostal Block Versus Serratus Anterior Plane Block for Mastectomy Surgery

NCT05518292 | Unknown Phase 2

• 1 other identifier: R.22.09.1830
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Breast surgeries are usually associated with sever postoperative pain ,good perioperative analgesic technique after breast surgery is always questionable .Thoracic epidural and paravertebral blocks became the gold standard techniques for pain relief ,however they may be associated with complications such as spinal cord injury, total spinal anesthesia ,inadvertent intravascular injection and pneumothorax . Recently , fascial plane blocks have been introduced as an alternative such as erector spinae plane block and serratus plane block Serratus plane block were introduced by Blanco et al where local anesthetic injected superficial to the muscle to provide nerve block of the lateral cutaneous branches of the intercostal nerves Rhomboid intercostal block is an interfascial plane block for chest wall analgesia, it was reported in 2016 as alternative to thoracic epidural and paravertebral blocks.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (6)

• numerical analog score

  0= no pain 10=sever pain

  half hour after finishing mastectomy

• numerical analog score

  0= no pain 10=sever pain

  1 hour after finishing mastectomy

• numerical analog score

  0= no pain 10=sever pain

  4 hour after finishing mastectomy

• numerical analog score

  0= no pain 10=sever pain

  8 hour after finishing mastectomy

• numerical analog score

  0= no pain 10=sever pain

  12 hour after finishing mastectomy

• numerical analog score

  0= no pain 10=sever pain

  24 hour after finishing mastectomy

Secondary Outcomes (1)

• required analgesia

  half hour after mastectomy

Study Arms (2)

rhomboid intercostal block

ACTIVE COMPARATOR

Ultrasound guided RIB will apply with 10-12 MHz linear ultrasound transducer, in plane technique. Patients will placed in the sitting position. 22G spinal needle needle will be inserted to plane between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2 cm to 3 cm medially from the medial border of the scapula. 20 ml of bupivacaine 0.25% will inject into the fascial plane.

Other: rhomboid intercostal block

serratus anterior plane block

ACTIVE COMPARATOR

Patients will placed in the lateral position with the diseased side up. A 10-12 MHz linear ultrasound transducer is placed over the mid-clavicular region of the thoracic cage in a sagittal plane. The fifth rib is identified in the mid-axillary line. The following muscles are identified easily overlying the fifth rib: the latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscle (deep and inferior). As an extra-reference point, the thoracodorsal artery is used to aid the identification of the plane superficial to the serratus muscle. The needle (22G spinal needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus muscle. Under continuous ultrasound guidance, 20 ml of bupivacaine 0.25% will inject.

Other: serratus anterior plane block

Interventions

rhomboid intercostal block OTHER

Ultrasound guided RIB will apply with 10-12 MHz linear ultrasound transducer, in plane technique. Patients will placed in the sitting position. 22G spinal needle needle will be inserted to plane between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2 cm to 3 cm medially from the medial border of the scapula. 20 ml of bupivacaine 0.25% will inject into the fascial plane.

rhomboid intercostal block

serratus anterior plane block OTHER

Patients will placed in the lateral position with the diseased side up. A 10-12 MHz linear ultrasound transducer is placed over the mid-clavicular region of the thoracic cage in a sagittal plane. The fifth rib is identified in the mid-axillary line. The following muscles are identified easily overlying the fifth rib: the latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscle (deep and inferior). As an extra-reference point, the thoracodorsal artery is used to aid the identification of the plane superficial to the serratus muscle. The needle (22G spinal needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus muscle. Under continuous ultrasound guidance, 20 ml of bupivacaine 0.25% will inject.

serratus anterior plane block

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I and II
• female patients
• aged between 20-60 years,
• undergoing modified radical mastectomy surgeries

You may not qualify if:

• local skin infection ,
• bleeding disorder ,
• coagulation abnormality ,
• spine or chest deformity ,
• psychiatric disease,
• pregnancy
• patients with allergy to any of the drug used

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Yahya Wahba

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assist. prof. of anesthesia and pain management

Study Record Dates

• First Submitted: August 13, 2022
• First Posted: August 26, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 30, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-09

Locations

EG (1)