Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy

NCT06019325 | Completed

• 1 other identifier: 230022
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief Summary

Rhomboid intercostal block is used to block lateral cutaneous branches of intercostal nerves between T3 and T9 dermatomes. RIB has been reported to be successful in attenuating acute pain following breast surgeries. However, it's effect on chronic pain has not been evaluated yet. The primary hypothesis of the study is that the incidence of chronic pain of the patients who will receive Rhomboid intercostal block (RIB) following breast cancer surgery will be lower than the patients who will receive no block intervention at the postoperative 3rd month. The secondary hypothesis is that the incidence ofchronic pain of the patients who will receive Rhomboid intercostal block (RIB) following breast cancer surgery will be lower than the patients who will receive no block intervention at the postoperative 6th month. An other secondary hypothesis is that the total BPI-SF scores will be lower in the RIB group than control group at the postoperative 3rd and the 6th months.

Conditions

Breast Cancer; Postoperative Pain, Acute; Postoperative Pain, Chronic; Neuropathic Pain

Keywords

analgesia; acute pain; chronic pain; neuropathic pain; rhomboid intercostal block

Outcome Measures

Primary Outcomes (1)

• 3rd month chronic pain

  The presence of chronic pain will be evaluated by using the 5. question of Brief Pain Inventory Short Form at the postoperative 3rd month. The question ranges from 0 (which means no pain) to 10 points (which means worst pain). The score equal to or over 4 points indicates the presence of chronic pain. Primary outcome of the study is the difference in the incidence of chronic pain between study and control groups at the postoperative 3rd month.

  At the postoperative 3. month

Secondary Outcomes (7)

• 6th month chronic pain

  At the postoperative 6. month

• 3rd month total Brief Pain Inventory Short Form Score

  At the postoperative 3. month

• 6th month total Brief Pain Inventory Short Form Score

  At the postoperative 6. month

• 3rd month neuropathic pain

  At the postoperative 3. month

• 6th month neuropathic pain

  At the postoperative 6. month

Study Arms (2)

Study Group

EXPERIMENTAL

After endotracheal intubation, patients will be positioned in lateral decubitus position. A linear ultrasound probe will be placed at the edge of scapula at the level of T5-T6. Under sterile conditions, the landmark points (rhomboid major muscle, 5th and 6th ribs, and intercostal muscles) will be observed and a block needle will be directed to the interfacial plane between rhomboid major muscle and intercostal muscle. RIB will be performed by injecting 30 ml of bupivacaine 0.25%.

Procedure: RIB

Control Group

NO INTERVENTION

No block procedure will be performed in this group.

Interventions

RIB PROCEDURE

After endotracheal intubation, patients will be positioned in lateral decubitus position. A RIB will be performed at the level of T5-T6 by ultrasound guidance. A single shot block will be performed by injecting 30 ml of 0.25% bupivacaine to the interfacial plane between rhomboid major muscle and intercostal muscle.

Study Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II patients
• Female
• Ages between 18-65
• Patients who will receive breast cancer surgery under general anesthesia

You may not qualify if:

• Alcohol or substance or chronic opioid consumption story
• Any pain killers intake in the last 24 hours prior to surgery
• Body mass index over 35 kg/m2
• Infection at the injection sites
• Known allergy to local anesthetics
• Known psychiatric diseases which prevents communication
• Operations longer than 3 hours

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Muğla Training and Research Hospital

Muğla, MENTEŞE, 48000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative; Neuralgia; Agnosia; Acute Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Perceptual Disorders; Neurobehavioral Manifestations

Study Officials

• BAKİYE UĞUR

  Muğla Sıtkı Koçman University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients will be under general anesthesia and will not be aware if they receive a block procedure or not. The investigator, the data collector and the outcome assessor will be completely blind to the study groups. Only the care provider who will perform the block procedures will know the study groups, but she will not involve in data collection.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Model Details: Prospective, randomized, controlled study

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 31, 2023
• Study Start: September 7, 2023
• Primary Completion: October 15, 2024
• Study Completion: April 15, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)