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Breast Neoplasm FemaleNCT06274814

U/S Guided Rhomboid Intercostal Block Combined With Sub-Serratus Plane Block vs Type 2 Pectoral Nerve Block

A study testing U/S guided Type 2 Pectoral Nerve Block and U/S guided RIB combined with the sub-serratus plane block (RISS) in people with Breast Neoplasm Female and Analgesics, run by National Cancer Institute, Egypt 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
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Trial summary

The aim of this study is to compare between U/S Guided Rhomboid Intercostal Block Combined with Sub-Serratus Plane Block vs type 2 Pectoral Nerve Block in Analgesia for Breast Cancer Surgery by measuring intraoperative hemodynamics, postoperative pain scores and morphine consumption in the first 24 h postoperative. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Breast Neoplasm Female, Analgesics
What is being tested?
U/S guided Type 2 Pectoral Nerve Block and U/S guided RIB combined with the sub-serratus plane block (RISS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
1 siteEgypt
Study dates
1 Jun 2023to 1 May 2024
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 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients.
  • Scheduled for unilateral conservative mastectomy.
  • Age 18-65 years.
  • American Society of Anesthesiologists (ASA) physical status I- II.

Who cannot join

  • Patient refusal.
  • Coagulation disorders.
  • Body mass index > 40 kg/m2.
  • Uncooperative or psychiatric patients.
  • Infection at the injection site.
  • Patients with a history of allergy to local anesthetics.
  • Patients with a history of treatment for chronic pain.
  • Previous history of breast surgery or other chest surgery.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • National cancer Insititute

    Cairo, 11796

Other trials in Egypt

About this study

Official title: Ultrasound Guided Rhomboid Intercostal Block Combined With Sub-Serratus Plane Block vs Type 2 Pectoral Nerve Block in Analgesia for Breast Cancer Surgery

The aim of this study is to compare between U/S Guided Rhomboid Intercostal Block Combined with Sub-Serratus Plane Block vs type 2 Pectoral Nerve Block in Analgesia for Breast Cancer Surgery by measuring intraoperative hemodynamics, postoperative pain scores and morphine consumption in the first 24 h postoperative.

Read the detailed description

Patients will be randomly allocated into three groups based on a computerized randomization table with specific ID for each patient (23 per group). Each patient will be prepared in Preoperative Holding Area with sedation with midazolam 0.05mg/kg patients allotted to the RIB group were positioned in the lateral decubitus position with the breast on the operating side lying superiorly. The ipsilateral arm was abducted from the chest to move the scapula laterally. The RISS was performed after application of antiseptic solution. A high-frequency using a 6-13 MHz linear ultrasound probe set to B mode (SonoSite M-turbo ultrasound machine) was placed medial to the medial border of the scapula in the oblique sagittal plane. The landmarks, i.e., the trapezius muscle, rhomboid muscle, intercostal muscles, pleura, and lung, were identified in the ultrasound. Under aseptic conditions, a 100-mm 21-gauge needle was inserted at the level of T5-6 in the ultrasound view. A single dose of 20-mL 0.25% bupivacaine was injected in the interfascial plane between the rhomboid major and intercostal muscles. The spread of the local anesthetic solution under the rhomboid muscle was visualized by ultrasonography. Thereafter, the ultrasound probe was moved caudally and laterally to identify the tissue plane between the serratus anterior and external intercostal muscles for the sub-serratus block at the T8-9 level. The needle was advanced from its previous position, and an additional 20 mL of 0.25% bupivacaine was injected. All block procedures were performed by the same anesthesiologist who had administered the RIB and RISS blocks in more than 30 cases before this study. In control group (Group C), no block intervention was performed.

After disinfection, using 30 mL of levobupivacaine 0.25% (10 mL between pectoralis minor muscle and pectoralis major muscle, and 20 mL between the pectoralis major muscle and serratus muscle). With the patient in supine position. (Group B) After shifting to the operative area, all patients underwent conventional monitoring procedures including electrocardiography, noninvasive monitoring of blood pressure, and peripheral oxygen saturation measurements. Intravenous access was gained using a 22-gauge intravenous needle, and isotonic saline was infused at a rate of 15 mL kg-1 h-1. Anesthetic management was in accordance with a standard protocol. Anesthesia was induced with pre-oxygenation for 3 min followed by intravenous injection of midazolam (0.05 mg/kg), fentanyl (0.1 µg/kg), propofol (1-2 mg/kg), and atracurium (0.5 mg/kg). An endotracheal tube was used for positive-pressure ventilation to maintain the end-tidal carbon dioxide level of 35-40 mmHg.

Anesthesia was maintained using 2% sevoflurane with 50% oxygen, fentanyl (0.1 µg kg-1 min-1), and propofol (100 µg kg-1 min-1). Additionally, atracurium (0. 1 mg/kg) was administered according to the surgical protocol. Surgery (Unilateral conservative mastectomy) was started. The anesthetic dose was adjusted to maintain blood pressure within 20% of the baseline value. An additional dose of intravenous fentanyl (0.1 µg kg-1 min-1) was injected as needed. If the blood pressure decreased by > 20% from the baseline value, 250 mL of 0.9% (physiologic) saline and ephedrine (0.1 mg/kg) were administered. If the heart rate decreased to less than 50 bpm, atropine (0.5 mg/kg) was administered. At the end of the surgery, the effect of atracurium was reversed using neostigmine and atropine as needed. After the surgery, the endotracheal tube was removed when the patient fulfills criteria of extubation. Then the patient will be transferred to the PACU.

Data will be collected:

  1. Intraoperative assessment: (readings will be taken just after induction and every 15 min throughout surgery)
  2. Heart rate intraoperative.
  3. Mean arterial blood pressure intraoperative.
  4. Analgesic consumption: recorded during intraoperative period to maintain maximum 20% change of basal vital signs after exclusion of other causes. (Intraoperative fentanyl consumption)
  5. Postoperative:
  6. Recovery time: the time taken to be fully awake and responding to commands.
  7. Pain score: VAS score at 0, 3, 6, 9,24h post-operative.
  8. Hemodynamic: pulse, B.P (systolic, diastolic, and mean blood pressure) at 0,3,6,9,24h postoperative.
  9. Side effects (nausea, vomiting, hematoma, hypotension, bradycardia).
  10. Rescue analgesia plane will be given for VAS≥4 using non-steroidal anti-inflammatory analgesic (ketorolac 30 mg) and VAS≥6 using opioid (3mg morphine). Time of the first rescue analgesia together with frequency and total dose of the given drug through the 24 hours will be recorded.
  11. Hospital discharge.

Primary outcome:

  1. Total morphine consumption in first 24 hours post operative.
  2. VAS score postoperative.

Secondary outcome:

  1. Heart rate intraoperative.
  2. Mean arterial blood pressure intraoperative.
  3. Timing of first rescue analgesia.
  4. Intraoperative fentanyl consumption.
  5. Side effects (nausea, vomiting, hematoma, hypotension, bradycardia).
  6. Body mass index (BMI).
Being tested
U/S guided Type 2 Pectoral Nerve Block, U/S guided RIB combined with the sub-serratus plane block (RISS)
Keywords
Analgesics, Opioids, Breast Neoplasms, Postoperative Pain, Mastectomy, Nerve block, Breast Cancer Surgery
Medical subject headings
Breast Neoplasms, Pain, Postoperative

What participants receive

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

  • U/S guided Type 2 Pectoral Nerve BlockProcedure or surgery

    20 mL separates the pectoralis major and minor muscles, while 10 mL separates the serratus and pectoralis major muscles

  • U/S guided RIB combined with the sub-serratus plane block (RISS)Procedure or surgery

    he ipsilateral arm was abducted. RISS was performed. Using a 6-13 MHz linear ultrasound probe was placed medial to the medial border of the scapula in the oblique sagittal plane.. A 100-mm 21-gauge needle was inserted at the level of T5-6 in the ultrasound view. A single dose of 20-mL 0.25% bupivacaine was injected in the interfascial plane between the rhomboid major and intercostal muscles. The spread of the local anesthetic solution under the rhomboid muscle was visualized by ultrasonography. Thereafter, the ultrasound probe was moved caudally and laterally to identify the tissue plane between the serratus anterior and external intercostal muscles for the sub-serratus block at the T8-9 level. The needle was advanced from its previous position, and an additional 20 mL of 0.25% bupivacaine was injected.

Study groups in NCT06274814
Study groupRoleWhat they receive
Type 2 Pectoral Nerve BlockActive comparator23 patients Type 2 Pectoral Nerve Block pecs2 Group A
Receives: Procedure: U/S guided Type 2 Pectoral Nerve Block
RISS Rhomboid intercostal block combined with the sub-serratus plane blockActive comparator23 patients the RIB combined with the sub-serratus plane block (RISS) Group B
Receives: Procedure: U/S guided RIB combined with the sub-serratus plane block (RISS)
No block interventionNo interventionroutine IV analgesia 23 patients no block intervention was performed. The anesthetic dose was adjusted to maintain blood pressure within 20% of the baseline value. An additional dose of intravenous fentanyl (0.1 µg kg-1 min-1) was injected as needed. Group C

What is being measured

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

  1. Total morphine consumption

    Visual Analog scale ≥6 using opioid (3mg morphine) VAS score is from 0 to 10 as 0 is no pain and 10 the wariest pain can ever experience

    Measured: 24 hours

  2. Visual Analog scale score postoperative

    Visual Analog scale≥4 using non-steroidal anti-inflammatory analgesic (ketorolac 30 mg) and VAS≥6 using opioid (3mg morphine) (0 mean no pain - 10 mean worset pain ever)

    Measured: 24 hours

Secondary outcomes (3)
  1. Intraoperative fentanyl consumption

    total fentanyl consumption

    Measured: intraoperative

  2. Heart rate intraoperative

    ≥ 20 % of base line

    Measured: intraoperative

  3. Timing of first rescue analgesia

    first time patient needs analgesia

    Measured: 24 hours

Timeline

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

  1. First posted23 Feb 2024
  2. Study start1 Jun 2023
  3. Primary completion1 Apr 2024
  4. Study completion1 May 2024

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
Single blind
Who is masked
Participant
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06274814
Sponsor's protocol ID
AP23.501.038
Status last verified
Jul 2024
First submitted
16 Feb 2024
Last updated
22 Jul 2024
Results posted
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 U/S guided Type 2 Pectoral Nerve Block and U/S guided RIB combined with the sub-serratus plane block (RISS) in people with Breast Neoplasm Female and Analgesics, run by National Cancer Institute, Egypt 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 8 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 22 Jul 2024. 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?

Total morphine consumption (time frame: 24 hours). The study lists 2 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 22 Jul 2024.

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