AzTrials
AzTrials

Pain, PostoperativeNCT06781346

Rhomboid Intercostal Block Compared With Thoracic Paravertebral Block in Breast Cancer Surgeries

A study testing Rhomboid Intercostal Block and Thoracic Paravertebral Block in people with Pain, Postoperative, run by Fayoum University Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Postoperative pain is a significant problem following breast surgery . If not treated in time, it may lead to delayed wound healing, respiratory depression, hemodynamic disorders, anxiety,other complications, and finally lead to difficult recovery of patients . Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Pain, Postoperative
What is being tested?
Rhomboid Intercostal Block and Thoracic Paravertebral Block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteEgypt
Study dates
15 Feb 2025to 15 Dec 2025
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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients 18 years of age or older .
  • American Society of Anesthesiologists (ASA) II-lll Scheduled for elective breast surgery for modified radical mastectomy, simple mastectomy, breast conservative surgery.

Who cannot join

  • Patient refusal.
  • Significant renal, hepatic and cardiovascular diseases.
  • History of allergy to one of the study drugs.
  • Any contraindication to regional anesthesia such as local infection or bleeding disorders.
  • Chronic opioid use, history of chronic pain and cognitive disorders.
  • Emergent surgeries

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Fayoum university Hospital

    El Fayoum Qesm, Faiyum Gove, 63514

Other trials in Egypt

About this study

Official title: Analgesic Efficacy of Rhomboid Intercostal Block Compared With Thoracic Paravertebral Block in Adult Patients Undergoing Breast Cancer Surgeries: A Randomized Controlled Double-blinded Study

Postoperative pain is a significant problem following breast surgery . If not treated in time, it may lead to delayed wound healing, respiratory depression, hemodynamic disorders, anxiety,other complications, and finally lead to difficult recovery of patients . Therefore, the prevention of postoperative pain is of great importance for patients.

Opioids, while effective in pain management, are linked to a spectrum of adverse effects, including respiratory depression, post-operative nausea and vomiting, pruritus and constipation. The adoption of multimodal analgesia following breast cancer surgery emerges as a pivotal strategy to mitigate the complications associated with opioid use in the postoperative period.[4] US-guided rhomboid intercostal block (US-RIB) is a new fascial block technique discovered by Elsharkawy et al in 2016.

Read more

Injection of local anaesthetic into the fascial plane between rhomboid major and intercostal muscles provided analgesia for both the anterior and posterior hemithorax,targets the lateral cutaneous branches of the ventral rami of the thoracic intercostal nerves from T2 to T9.

Some clinical studies have reported that RIB can effectively reduce postoperative pain, reduce opioid consumption and improve the quality of recovery in patients with breast cancer surgeries .

The ultrasound guided Thoracic paravertebral (TPV) block in the context of breast cancer surgery has been reported to decrease postoperative pain score up to 72 hours, reduce opioid consumption, improve the quality of recovery, and suppress the development or decrease the severity of chronic pain by anesthetizing the spinal nerves as they emerge from the intervertebral foramina, producing ipsilateral somatosensory, visceral and sympathetic nerve blockade. TPV block involves the injection of local anesthetic (LA) into the wedge-shaped paravertebral space deep to the superior costotransverse ligament (SCTL).

In our study investigators hypothesized that the Rhomboid Intercostal block (RIB) can provide an effective analgesia comparable with thoracic paravertebral (TPV) block without the necessity to approach the pleura and the attendant risks in adult patients undergoing Breast cancer surgeries.

Read the detailed description

After approval of the local institutional ethics committee and local institutional review board. Patients who are scheduled for elective breast cancer surgeries and fulfilling the inclusion criteria in Fayoum university hospital starting from june 2024 will be enrolled in this randomized controlled study until fulfilling sample size. A detailed informed consent will be signed by the eligible participants before recruitment.

The patients will be randomized into two groups: RI block group and TPV block group in a 1:1 ratio using a computer-generated random table. The patient's assigned group information will be elicited from a sealed opaque envelope by the anesthesiologist who will perform the US-guided Rl and TPV block and will not be involved in further data collection or patient care. The patients and both the surgical and anesthesia teams, who are responsible for patient care and data collection will be blinded from the group assignments.

ANESTHETIC TECHNIQUE In this study,. All patients will be monitored using electrocardiography, pulse-oximetry, capnography,Non invasive Blood Pressure for blood pressure monitoring in the operating room.

After pre-oxygenation, general anesthesia will be induced with intravenous propofol (2 mg/kg) and fentanyl (1 μg/kg). After muscle relaxation with atracurium (0.5mg/kg), tracheal intubation will be performed by a cuffed endotracheal tube ,mechanical ventilation will be adjusted to maintain the end-tidal Carbon dioxide between 30 and 35 mmHg. Maintenance of anesthesia will be made using IV atracurium and inhalational anesthesia (isoflurane) starting at one minimal alveolar concentration (MAC) and will be adjusted to obtain an adequate level of anesthesia by titrating the concentration according to the BIS monitoring (BIS Complete Monitoring System P/N 185-0151 Covidien IIc, 15 Hampshire Street, Mansfield, MA 02048 USA) to keep the BIS value between 40 and 60.

After induction , the patient will be placed in the lateral decubitus position. The same anesthesiologist will perform the block.

In both groups, the T1-T12 thoracic spinal levels will be sonographically identified using a high frequency linear US probe (HFL_50, 15_6MHz). Then the probe will be placed vertically and nearly 3 cm lateral to the spinous process at the thoracic level T4/T5. The paraspinal muscles (erector spinae, trapezius, rhomboid), transverse processes , superior costo-transverse ligament (SCTL) and parietal pleura will be all identified under parasagittal scanning.

In RI block group, A 22 G, 50mm block needle (SONOTAP,Pajunk, -Geisingen,Germany) will be inserted in the cranial to caudal direction via an in-plane approach between the medial border of the scapula between the 4th and 5th rib of the patients in the RIB group. In the ultrasound image, the trapezius muscle, rhomboid muscle, intercostal muscles,pleura, and lung were identified. Under the aseptic condition, inserted laterally in the plane of the T5 level guided by an ultrasound probe with an in plane technique. The intravascular injection should be confirmed negative through aspiration, and 1-3 ml of normal saline was injected to divide the rhomboid and intercostal muscle, and a total volume of 20 ml of bupivacaine 0.25% ( not exceeding a maximum dose of 2 mg/kg) will be injected After negative aspiration of blood or air, injected into the deep layer of the rhomboid muscle.

In the TPV block group , the transverse process and the pleura will be identified and needle will be inserted in the cranial to caudal direction till it pierces the SCTL and reaches the paravertebral space. After negative aspiration of blood or air a total volume of 20 ml of bupivacaine 0.25% will be injected displacing the pleura downwards.

After 15 min , an incision will be made to perform the surgical procedure. . Continuous hemodynamic monitoring of blood pressure and heart rate will be done . If the systolic blood pressure decreased to a 20% below the baseline, 5 mg of ephedrine will be injected IV. Moreover, if the heart rate reduced to a 50 beat per minute or less , 0.5 mg of atropine will be injected IV.

Intraoperative if blood pressure increases over 20% of baseline and BIS value is between 40-60 we will give fentanyl (1 μg/kg)

At the end of the surgery, isoflurane will be discontinued and the muscle relaxant will be antagonized with neostigmine (0.04-0.08 mg/kg) and atropine (0.01 mg/kg) and will be extubated when the patient meets the following criteria: awake or arousable, hemodynamically stable, no ongoing active bleeding and warm extremities , after the return of spontaneous respiration.

At post anesthesia care unit all patients will be monitored blood pressure , heart rate and oxygen saturation , The patient's pain will be evaluated using a Visual Analog Scale (VAS) Both during rest and with cough (0: no pain, 10: worst pain ever) at time zero (postoperative when patient is fully conscious and can assess and evaluate pain) if there is pain patient will receive ketorolac 30mg IV and Paracetamol 1 gm IV

After admission at ward at the end of surgery, all patients will receive IV fentanyl via patient controlled analgesia (PCA) with concentration 10 μg/ml , with bolus 15 μg and lockout interval 10 minutes and maximum dose of 90 μg/hr with no background dose for 24 hours. Paracetamol 1 gm IV will be given every 8 hours.. The patient's pain will be evaluated using a Visual Analog Scale (VAS) (0: no pain, 10: worst pain ever) at time intervals: Time zero (when patient is fully conscious and can assess and evaluate the pain) then 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, and 24h postoperative.

Being tested
Rhomboid Intercostal Block, Thoracic Paravertebral Block
Keywords
Rhomboid Intercostal block, Breast surgery
Medical subject headings
Pain, Postoperative

What participants receive

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

  • Rhomboid Intercostal BlockProcedure or surgery

    In RI block group, A 22G, 50mm block needle (SONOTAP,Pajunk, -Geisingen,Germany) will be inserted in the cranial to caudal direction via an in-plane approach between the medial border of the scapula between the 4th and 5th rib of the patients in the RIB group. In the ultrasound image, the trapezius muscle, rhomboid muscle, intercostal muscles,pleura, and lung were identified. Under the aseptic condition, inserted laterally in the plane of the T5 level guided by an ultrasound probe with an in plane technique. The intravascular injection should be confirmed negative through aspiration, and 1-3 ml of normal saline was injected to divide the rhomboid and intercostal muscle, and a total volume of 20 ml of bupivacaine 0.25% ( not exceeding a maximum dose of 2 mg/kg) will be injected After negative aspiration of blood or air, injected into the deep layer of the rhomboid muscle.

  • Thoracic Paravertebral BlockProcedure or surgery

    In the TPV block group , the transverse process and the pleura will be identified and needle will be inserted in the cranial to caudal direction till it pierces the SCTL and reaches the paravertebral space. After negative aspiration of blood or air a total volume of 20 ml of bupivacaine 0.25% will be injected displacing the pleura downwards.

Study groups in NCT06781346
Study groupRoleWhat they receive
Rhomboid intercostal blockExperimentalA 22G, 50mm block needle (SONOTAP,Pajunk, -Geisingen,Germany) will be inserted in the cranial to caudal direction via an in-plane approach between the medial border of the scapula between the 4th and 5th rib of the patients in the RIB group. In the ultrasound image, the trapezius muscle, rhomboid muscle, intercostal muscles,pleura, and lung were identified. Under the aseptic condition, inserted laterally in the plane of the T5 level guided by an ultrasound probe with an in plane technique.
Receives: Procedure: Rhomboid Intercostal Block
Thoracic paravertebral blockActive comparatorthe transverse process and the pleura will be identified and needle will be inserted in the cranial to caudal direction till it pierces the SCTL and reaches the paravertebral space.
Receives: Procedure: Thoracic Paravertebral Block

What is being measured

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

  1. The total postoperative fentanyl consumption in the first 24 hours. (μg)

    The total postoperative fentanyl consumption in the first 24 hours. (μg)

    Measured: in the first 24 hours.

Secondary outcomes (8)
  1. Total intraoperative fentanyl

    Total intraoperative fentanyl

    Measured: Intraoperative

  2. Blood pressure

    Blood pressure intraoperative

    Measured: 24 hours postoperative

  3. Time to first analgesic request

    Postoperative

    Measured: 24 hours postoperative

  4. VAS score

    Both during rest and with cough (score 0 =no pain and 10 =worst pain ever) in the two groups of the study

    Measured: 24 hours postoperative

  5. Complications related to the block : pleural puncture , vascular puncture and local anesthesia systemic toxicity.

    Intraoperative

    Measured: Intraoperative

  6. Complications related to IV opioids

    nausea and vomiting (0 = no symptoms, 1 = only nausea, 2 = nausea and vomiting), respiratory depression (respiratory rate less than 10), sedation (0 = awake and alert, 1 = quietly awake, 2 = asleep but easily arousable, 3 = deep sleep, responding to painful stimulus), pruritus(0=no symptoms, 1=mild pruritus, 2 moderate pruritus, 3 sever pruritus)

    Measured: 24 hours postoperative

  7. Hospital length of stay

    Postoperative

    Measured: 24 hours Postoperative

  8. Participant satisfaction will be assessed on a 4-point scale (1:excellent , 2: good 3: fair, 4: poor).

    Postoperative

    Measured: 24 hours postoperative

Timeline

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

  1. First posted17 Jan 2025
  2. Study start15 Feb 2025
  3. Primary completion15 Dec 2025
  4. Study completion15 Dec 2025

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06781346
Sponsor's protocol ID
M 729
Status last verified
Jan 2025
First submitted
17 Dec 2024
Last updated
9 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Elsharkawy H, Saifullah T, Kolli S, Drake R. Rhomboid intercostal block. Anaesthesia. 2016 Jul;71(7):856-7. doi: 10.1111/anae.13498. No abstract available.

    PubMed 27291611
  • Tulgar S, Selvi O, Thomas DT, Manukyan M, Ozer Z. Rhomboid intercostal block in a modified radical mastectomy and axillary curettage patient; A new indication for novel interfascial block. J Clin Anesth. 2019 May;54:158-159. doi: 10.1016/j.jclinane.2018.12.006. Epub 2018 Dec 13. No abstract available.

    PubMed 30553225
  • Piraccini E, Biondi G, Corso RM, Maitan S. The use of rhomboid intercostal block, parasternal block and erector spinae plane block for breast surgery. J Clin Anesth. 2020 Feb;59:10. doi: 10.1016/j.jclinane.2019.06.004. Epub 2019 Jun 6. No abstract available.

    PubMed 31176954
  • Tulgar S, Kiziltunc B, Thomas DT, Manukyan MN, Ozer Z. The combination of modified pectoral nerves block and rhomboid intercostal block provides surgical anesthesia in breast surgery. J Clin Anesth. 2019 Dec;58:44. doi: 10.1016/j.jclinane.2019.04.040. Epub 2019 May 7. No abstract available.

    PubMed 31075623
  • Terkawi AS, Tsang S, Sessler DI, Terkawi RS, Nunemaker MS, Durieux ME, Shilling A. Improving Analgesic Efficacy and Safety of Thoracic Paravertebral Block for Breast Surgery: A Mixed-Effects Meta-Analysis. Pain Physician. 2015 Sep-Oct;18(5):E757-80.

    PubMed 26431130

Questions about this trial

What is this clinical trial studying?

A study testing Rhomboid Intercostal Block and Thoracic Paravertebral Block in people with Pain, Postoperative, run by Fayoum University Hospital at 1 site in Egypt.

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 6 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: finished, as of the sponsor's last update on 9 Sep 2026. 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 Egypt. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The total postoperative fentanyl consumption in the first 24 hours. (μg) (time frame: in the first 24 hours.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06781346, which also lists 5 linked publications.

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 9 Sep 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in