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PainNCT03942003

Analgesic Effects of Rhomboid Block

A study testing rhomboid blocks and PEC blocks in people with Pain and Anesthesia, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Pain, Anesthesia
What is being tested?
rhomboid blocks and PEC blocks
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2019to 20 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • mastectomy
  • general anesthesia

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Savaş Altınsoy contact

+903125962553

savasaltinsoy@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • University of Health Siences Diskapi Yildirim Beyazit T&R hospital

    Ankara

    SAVAS ALTINSOY, +903125962553, savasaltinsoy@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Analgesic Effects of the Rhomboid Intercostal Block and Pectoral Nerve Block Applied in Breast Surgery

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.

Read the 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
Being tested
rhomboid blocks, PEC blocks, Control groups
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rhomboid blocksProcedure or surgery

    Rhomboid nerve block was performed

  • PEC blocksProcedure or surgery

    PEC I-II blocks was performed

  • Control groupsProcedure or surgery

    Infiltration analgesia was performed

Study groups in NCT03942003
Study groupRoleWhat they receive
RhomboidExperimentalWhen 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.
Receives: Procedure: rhomboid blocks
PectoralExperimentalThe 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
Receives: Procedure: PEC blocks
ControlSham comparatorInfiltration analgesia was performed.
Receives: Procedure: Control groups

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: at first 24 hour of postoperative period

Secondary outcomes (1)
  1. Sleep quality: NRS

    The postoperative first night sleep quality of the patients will be recorded with NRS (0 = not sleeping all night, 10 = very good sleep).

    Measured: at first morning after operation day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2019
  2. Study start1 Jun 2019
  3. Primary completion1 May 2021
  4. Study completion20 Aug 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03942003
Sponsor's protocol ID
Rhomboid
Status last verified
Jul 2021
First submitted
6 May 2019
Last updated
12 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing rhomboid blocks and PEC blocks in people with Pain and Anesthesia, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Savaş Altınsoy (+903125962553, savasaltinsoy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative analgesic consumption (time frame: at first 24 hour of postoperative period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.

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