Analgesic Effects of Rhomboid Block

NCT ID: NCT03942003

Last Updated: 2021-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2021-08-20

Brief Summary

Breast surgery is a common surgical procedure because of the prevalence of breast cancer. Postoperative analgesia management in breast surgery is difficult due to the content of the surgical procedure and the complex innervation of the breast. Multimodal approach is recommended for postoperative analgesia. Therefore, various methods are used. There was no comparison of these two blocks to control group in the literature. In this study, the investigators planned to investigate the postoperative pain, analgesic usage dose and side effects of patients undergoing breast surgery under general anesthesia with a rhomboid area block, pectoral area block.

Detailed Description

Regional methods and pharmacological treatments are among these methods. The blocks of serratus, pectoral and rhomboid from the regional blocks are used more safely and with increasing frequency, especially with the introduction of ultrasonography in the clinic. In 2016, the rhomboid intercostal nerve block was identified and presented in the literature as a case report. In the rhomboid block, the analgesia created by the local anesthetic on the anterior thoracic wall was used. For patients who will undergo elective breast surgery, the routine routinely applied in our clinic is a multimodal approach, which involves conducting a peripheral nerve block following general anesthesia induction for postoperative analgesia. All patients before the block are standardized and intravenous vascular access is opened. In our clinic, all peripheral blocks are performed under sterile conditions accompanied by ultrasound and stimulator. When applying the Rhomboid nerve block, the patient is tilted to the side position so that the corresponding breast is at the top. After T7 up to T10 sterile preparation of the C7 spinous projection, the convex probe shows a rhomboid muscle at the level of T5 and block is applied with 0.25% bupivacaine (20 cc), 2% lidocaine (10 cc) and 10 cc SF mixture. The PEC I field block is performed by administering 10 cc of local anesthetic between the pectoralis minor and the major at the 2nd costal position. PEC II field block is performed using linear USG probe visibly in 3rd and 4th ribs while the patient is in supine position. In this block, a total of 20 cc 0.25% bupivacaine (10 cc), 2% lidocaine (5 cc) and 5 cc SF mixture were used to block the area between the pectoralis minor muscle and the serratus muscle. Sensory block is evaluated with cold stimulus (0 = no cold sensation, 1 = cold feeling severely decreased, 2 = cold feeling slightly reduced, 3 = normal cold feeling). Patients undergoing breast surgery routinely undergo general anesthesia with propofol 2-3 mg / kg, fentanyl 1mcq / kg, lidocaine 1 mg / kg and rocuronium 0.6 mg / kg. The postoperative analgesic needs of the patients will be recorded in the patient-controlled analgesia device. Postoperative pain, digital evaluation scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) of all patients will be recorded.

Conditions

Pain; Anesthesia

Study Design

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

Study Groups

Rhomboid

When applying the Rhomboid nerve block, the patient is tilted to the side position so that the corresponding breast is at the top. After T7 up to T10 sterile preparation of the C7 spinous projection, the convex probe shows a rhomboid muscle at the level of T5 and block is applied with 0.25% bupivacaine (20 cc), 2% lidocaine (10 cc) and 10 cc SF mixture.

Group Type: EXPERIMENTAL

rhomboid blocks

Intervention Type: PROCEDURE

Rhomboid nerve block was performed

Pectoral

The PEC I field block is performed by administering 10 cc of local anesthetic between the pectoralis minor and the major at the 2nd costal position. PEC II field block is performed using linear USG probe visibly in 3rd and 4th ribs while the patient is in supine position. In this block, a total of 20 cc 0.25% bupivacaine (10 cc), 2% lidocaine (5 cc) and 5 cc SF mixture were used to block the area between the pectoralis minor muscle and the serratus muscle

Group Type: EXPERIMENTAL

PEC blocks

Intervention Type: PROCEDURE

PEC I-II blocks was performed

Control

Infiltration analgesia was performed.

Group Type: SHAM_COMPARATOR

Control groups

Intervention Type: PROCEDURE

Infiltration analgesia was performed

Interventions

rhomboid blocks

Rhomboid nerve block was performed

Intervention Type: PROCEDURE

PEC blocks

PEC I-II blocks was performed

Intervention Type: PROCEDURE

Control groups

Infiltration analgesia was performed

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• mastectomy
• general anesthesia

Exclusion Criteria

• Diabetes mellitus
• Chronic analgesic treatment
• cardiovascular disease
• non-cooperative patients

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

Sponsors

Diskapi Yildirim Beyazit Education and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Savas Altinsoy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Health Siences Diskapi Yildirim Beyazit T&R hospital

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Savaş Altınsoy

Role: CONTACT

savasaltinsoy@gmail.com

+903125962553

Facility Contacts

SAVAS ALTINSOY

Role: primary

savasaltinsoy@gmail.com

+903125962553

Other Identifiers

Rhomboid

Identifier Type: -

Identifier Source: org_study_id