Analgesic Effects of Rhomboid Block

NCT03942003 | Unknown

• 1 other identifier: Rhomboid
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Postoperative analgesic consumption

  Postoperative analgesic needs of 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.

  at first 24 hour of postoperative period

Secondary Outcomes (1)

• Sleep quality: NRS

  at first morning after operation day

Study Arms (3)

Rhomboid

EXPERIMENTAL

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.

Procedure: rhomboid blocks

Pectoral

EXPERIMENTAL

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

Procedure: PEC blocks

Control

SHAM COMPARATOR

Infiltration analgesia was performed.

Procedure: Control groups

Interventions

rhomboid blocks PROCEDURE

Rhomboid nerve block was performed

Rhomboid

PEC blocks PROCEDURE

PEC I-II blocks was performed

Pectoral

Control groups PROCEDURE

Infiltration analgesia was performed

Control

Eligibility Criteria

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

You may qualify if:

• mastectomy
• general anesthesia

You may not qualify if:

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

Sponsors & Collaborators

• Diskapi Yildirim Beyazit Education and Research Hospital: lead

Study Sites (1)

University of Health Siences Diskapi Yildirim Beyazit T&R hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Savaş Altınsoy

CONTACT

+903125962553; savasaltinsoy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 8, 2019
• Study Start: June 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: August 20, 2021
• Last Updated: July 12, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)