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

NCT ID: NCT06019325

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 254 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-07
• Study Completion Date: 2025-04-15

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.

Detailed Description

The study is designed as a prospective, double-blinded, randomize controlled study. The patients who will undergo mastectomy surgery with or without axillary dissection will be included in the study. Anesthesia will be inducted with intravenous (iv) thiopental 5 mg/kg, fentanyl 2 mcg/kg and rocuronium bromide 0.6 mg/kg. Following intubation, patients will be allocated into two groups according to a randomization table created by a professional statistician. In the study group, patients will receive a single shot Rhomboid Intercostal Block (RIB) with 30 milliliters of %0.25 bupivacaine and in the control group no block procedure will be performed. All patients will receive a standard analgesia protocol which will include an intraoperative intravenous (iv) infusion of dexketoprofen 50 mg and iv tramadol 1 mg/kg 15 minutes prior to the end of the surgery. Postoperative pain intensity of the patients will be evaluated by Numerical Rating Scale (NRS) which is a scale ranges between 0 (no pain) and 10 (the worst pain that a person can stand). Pain scores of the patients will be recorded at the postoperative 15. and 30. min in the recovery room and if the NRS score is 4 or more, iv fentanyl 1 mcg/kg will be applied. At the surgical ward, pain scores will be evaluated at the postoperative 1st, 2nd, 6th, 12th and 24th hours and if the NRS score is 4 or more, iv tramadol 50 mg will be applied as rescue analgesia. Opioid consumptions of the patients will be recorded at the postoperative 24th hour. At the postoperative 3. and 6. months, a pain doctor will evaluate all patients by using Brief Pain Inventory Short Form (BPI-SF) and Douleur Neuropathique 4 (DN4) questionnaire.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Study Group

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%.

Group Type: EXPERIMENTAL

RIB

Intervention Type: 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.

Control Group

No block procedure will be performed in this group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

RIB

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Muğla Sıtkı Koçman University

OTHER

Sponsor Role: lead

Responsible Party

Başak Altıparmak

Associated Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

BAKİYE UĞUR

Role: STUDY_CHAIR

Muğla Sıtkı Koçman University

Locations

Muğla Training and Research Hospital

Muğla, MENTEŞE, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

230022

Identifier Type: -

Identifier Source: org_study_id