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AzTrials

Breast CancerPhase 2/3NCT05518292

Comparison of Analgesic Efficacy of Ultrasound Guided Rhomboid Intercostal Block Versus Serratus Anterior Plane Block for Mastectomy Surgery

A Phase 2/3 study testing rhomboid intercostal block and serratus anterior plane block in people with Breast Cancer, run by Mansoura University at 1 site in Egypt.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 surgeries are usually associated with sever postoperative pain ,good perioperative analgesic technique after breast surgery is always questionable .Thoracic epidural and paravertebral blocks became the gold standard techniques for pain relief ,however they may be associated with complications such as spinal… Read more about this study

Who is it for?
Ages 20 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
rhomboid intercostal block and serratus anterior plane block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Sep 2022to 30 Dec 2022
Phase
Phase 2/3
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 20 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • ASA I and II
  • female patients
  • aged between 20-60 years,
  • undergoing modified radical mastectomy surgeries

Who cannot join

  • local skin infection ,
  • bleeding disorder ,
  • coagulation abnormality ,
  • spine or chest deformity ,
  • psychiatric disease,
  • pregnancy
  • patients with allergy to any of the drug used

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting
  • Yahya Wahba

    Al Mansurah

    yahya m wahba, assist prof., 01211313554, yahyawahba@gmail.com

    nevert a abdel ghaffar, assist prof

    Recruiting

Other trials in Egypt

About this study

Breast surgeries are usually associated with sever postoperative pain ,good perioperative analgesic technique after breast surgery is always questionable .Thoracic epidural and paravertebral blocks became the gold standard techniques for pain relief ,however they may be associated with complications such as spinal cord injury, total spinal anesthesia ,inadvertent intravascular injection and pneumothorax . Recently , fascial plane blocks have been introduced as an alternative such as erector spinae plane block and serratus plane block Serratus plane block were introduced by Blanco et al where local anesthetic injected superficial to the muscle to provide nerve block of the lateral cutaneous branches of the intercostal nerves Rhomboid intercostal block is an interfascial plane block for chest wall analgesia, it was reported in 2016 as alternative to thoracic epidural and paravertebral blocks.

Read the detailed description

This double blinded randomized(closed envelope technique) study will be conducted on eighty ASA I and II female patients aged between 20-60 years, undergoing modified radical mastectomy surgeries at Oncology Center Mansoura University (OCMU). The study will start at September 2022 and the recruitment will take approximately five months. The study duration can take about eight months. All patients undergoing general anesthesia. Informed consent will be taken after approval by the local ethics committee. The exclusion criteria included local skin infection , bleeding disorder ,coagulation abnormality ,spine or chest deformity , psychiatric disease, pregnancy and patients with allergy to any of the drug used .

Patients will be randomly assigned to either two groups according to the block used either rhomboid plane block in group R (n=30) received total volume of 20 ml of bupivacain 0.25% or serratus plane block group S (n=30) received total volume of 20 ml of bupivacaine 0.5% . The observer anesthetist and the surgeon were blinded to the solution. Operation will be performed by the same surgeon .Anesthetic management will be standardized and all patients will be premedicated with diazepam 5mg per orally at the morning of the surgery. Induction will be started with preoxygenation for 3 min, anesthesia will be induced with fentanyl (2ug/kg), 2 mg/kg propofol, muscle relaxation will be achieved by atracurium 0.05 mg kg and tracheal intubation will be achieved using suitable size of endotracheal tube . Anesthesia will be maintained with minimum alveolar concentration(MAC ) of isoflurane with air - oxygen and fentanyl 1µg/kg boluses and atracurium 0.2 mg/kg to maintain heart rate and pressure within 20% of their baseline values, the patients' lungs will be ventilated to maintain an ETCO2 of 30-35 mmHg. . Isoflurane will be discontinued at the start of skin closure, residual neuromuscular block will be antagonized with neostigmine 0.05 mg kg and atropine 0.025 mg kg and the trachea will be extubated. Heart rate ,end-tidal CO2, pulse oximetry and systolic blood pressure and diastolic blood pressure will be recorded before induction of anesthesia (baseline) and after induction of anesthesia then every 5min during surgery till end of surgery .

Post operative assessment:

In the PACU , patients were monitored for heart rate ,oxygen saturation ,systolic blood pressure and diastolic blood pressure for 1 hour postoperative by another anesthetist who was not aware of the study protocol . Patients were discharged to the surgical ward if they achieved score of 10 at modified Aldrete score .

Postoperative severity of pain which was assessed using VAS 1/2 hour after surgery, then at 1h, 2h, 4h, 6 h, 8h,12h and 24 h postoperatively . All patients were given IV ketorolac 30 mg/8 hour postoperatively and IV fentanyl 0.5µg/kg was available as rescue analgesia whenever VAS continued to be>40 mm after 30 min of ketorolac injection. Fentanyl injection could be repeated. The time for the first postoperative analgesic dose requirements and the total dose of 24hour postoperative fentanyl consumption were recorded . Postoperative nausea and vomiting (PONV) were assessed using a four-point numerical scale (0=no PONV, 1=mild nausea, 2=severe nausea or vomiting once, and 3=vomiting more than once), postoperative adverse effects and complications were recorded .

Conditions
Breast Cancer
Being tested
rhomboid intercostal block, serratus anterior plane block
Medical subject headings
Breast Neoplasms

What participants receive

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

  • rhomboid intercostal blockOther

    Ultrasound guided RIB will apply with 10-12 MHz linear ultrasound transducer, in plane technique. Patients will placed in the sitting position. 22G spinal needle needle will be inserted to plane between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2 cm to 3 cm medially from the medial border of the scapula. 20 ml of bupivacaine 0.25% will inject into the fascial plane.

  • serratus anterior plane blockOther

    Patients will placed in the lateral position with the diseased side up. A 10-12 MHz linear ultrasound transducer is placed over the mid-clavicular region of the thoracic cage in a sagittal plane. The fifth rib is identified in the mid-axillary line. The following muscles are identified easily overlying the fifth rib: the latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscle (deep and inferior). As an extra-reference point, the thoracodorsal artery is used to aid the identification of the plane superficial to the serratus muscle. The needle (22G spinal needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus muscle. Under continuous ultrasound guidance, 20 ml of bupivacaine 0.25% will inject.

Study groups in NCT05518292
Study groupRoleWhat they receive
rhomboid intercostal blockActive comparatorUltrasound guided RIB will apply with 10-12 MHz linear ultrasound transducer, in plane technique. Patients will placed in the sitting position. 22G spinal needle needle will be inserted to plane between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2 cm to 3 cm medially from the medial border of the scapula. 20 ml of bupivacaine 0.25% will inject into the fascial plane.
Receives: Other: rhomboid intercostal block
serratus anterior plane blockActive comparatorPatients will placed in the lateral position with the diseased side up. A 10-12 MHz linear ultrasound transducer is placed over the mid-clavicular region of the thoracic cage in a sagittal plane. The fifth rib is identified in the mid-axillary line. The following muscles are identified easily overlying the fifth rib: the latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscle (deep and inferior). As an extra-reference point, the thoracodorsal artery is used to aid the identification of the plane superficial to the serratus muscle. The needle (22G spinal needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus muscle. Under continuous ultrasound guidance, 20 ml of bupivacaine 0.25% will inject.
Receives: Other: serratus anterior plane block

What is being measured

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

  1. numerical analog score

    0= no pain 10=sever pain

    Measured: half hour after finishing mastectomy

  2. numerical analog score

    0= no pain 10=sever pain

    Measured: 1 hour after finishing mastectomy

  3. numerical analog score

    0= no pain 10=sever pain

    Measured: 4 hour after finishing mastectomy

  4. numerical analog score

    0= no pain 10=sever pain

    Measured: 8 hour after finishing mastectomy

  5. numerical analog score

    0= no pain 10=sever pain

    Measured: 12 hour after finishing mastectomy

  6. numerical analog score

    0= no pain 10=sever pain

    Measured: 24 hour after finishing mastectomy

Secondary outcomes (1)
  1. required analgesia

    numerical analog score more than 4

    Measured: half hour after mastectomy

Timeline

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

  1. First posted26 Aug 2022
  2. Study start1 Sep 2022
  3. Primary completion1 Dec 2022 (estimated)
  4. Study completion30 Dec 2022 (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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05518292
Sponsor's protocol ID
R.22.09.1830
Status last verified
Sep 2022
First submitted
13 Aug 2022
Last updated
28 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing rhomboid intercostal block and serratus anterior plane block in people with Breast Cancer, run by Mansoura University 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 4 inclusion and 7 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 28 Sep 2022. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

numerical analog score (time frame: half hour after finishing mastectomy). The study lists 6 primary outcomes in all. 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 28 Sep 2022.

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