About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.

Analgesic Effects of Rhomboid Block

Clinicaltrials.gov identifier NCT03942003

Recruitment Status Recruiting

First Posted May 8, 2019

Last update posted September 30, 2019

Study Description

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.

  • Condition or Disease:Pain
    Anesthesia
  • Intervention/Treatment: Procedure: rhomboid blocks
    Procedure: PEC blocks
    Procedure: Control groups
  • Phase: N/A
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. The degree of dyspnea and the degree of dyspnea were evaluated with NRS after 30 minutes. Dyspnea assessment is performed with NRS (Numeric Rating Scale 0 = no dyspnea, 10 = as badly as possible). 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. This method is a routine method in our clinic and is not an extra special application. Postoperative pain, digital evaluation scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) of all patients will be recorded.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 60 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Treatment
  • Official Title: Investigation of the Analgesic Effects of the Rhomboid Intercostal Block and Pectoral Nerve Block Applied in Breast Surgery
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: October 2019
  • Estimated Study Completion Date: December 2019
Arms and interventions
Arm Intervention/treatment
Experimental: 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.
Procedure: rhomboid blocks
Rhomboid nerve block was performed
Experimental: 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
Procedure: PEC blocks
PEC I-II blocks was performed
Sham Comparator: Control
Infiltration analgesia was performed.
Procedure: Control groups
Infiltration analgesia was performed
Outcome Measures
  • Primary Outcome Measures: 1. Postoperative analgesic consumption [ Time Frame: at first 24 hour of postoperative period ]
    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.
  • Secondary Outcome Measures: 1. Sleep quality: NRS [ Time Frame: at first morning after operation day ]
    The postoperative first night sleep quality of the patients will be recorded with NRS (0 = not sleeping all night, 10 = very good sleep).
Eligibility Criteria
  • Ages Eligible for Study: 18 to 70 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- mastectomy

- general anesthesia

Exclusion Criteria:

- Diabetes mellitus

- Chronic analgesic treatment

- cardiovascular disease

- non-cooperative patients

Contacts and Locations
Contacts

Contact: Savaş Altınsoy +903125962553 savasaltinsoy@gmail.com

Locations

Turkey
University of Health Siences Diskapi Yildirim Beyazit T&R hospital
Ankara

Sponsors and Collaborators

Diskapi Yildirim Beyazit Education and Research Hospital

More Information
  • Responsible Party: Diskapi Yildirim Beyazit Education and Research Hospital
  • ClinicalTrials.gov Identifier: NCT03942003 History of Changes
  • Other Study ID Numbers: Rhomboid
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: September 30, 2019
  • Last Verified: September 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No