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Breast NeoplasmsNCT06322316

Analgesic Efficacy of U/S Retrolaminar Block and Erector Spinae Plane Block in MRM

A study testing The Ultrasound-guided Retrolaminar Block Group and The Ultrasound-guided Erector Spinae Plane Block Group in people with Breast Neoplasms and Analgesia, 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

Modified radical mastectomy (MRM) is the most commonly performed surgical procedure in breast cancer patients and is usually associated with severe postoperative pain. The peripheral nerve block techniques were suggested to reduce acuter post-mastectomy pain. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Breast Neoplasms, Analgesia
What is being tested?
The Ultrasound-guided Retrolaminar Block Group and The Ultrasound-guided Erector Spinae Plane Block Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Oct 2022to 1 Apr 2023
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
  • Type of surgery; Modified Radical Mastectomy (MRM)
  • Physical status ASA I, II, III.
  • Age ≥ 18 and ≤ 65 Years.
  • Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.

Who cannot join

  • Age <18 years or >65 years
  • BMI <20 kg/m2 and >35 kg/m2
  • Known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).
  • History of psychological disorders and/or chronic pain.
  • Contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
  • Patient refusal.
Show all 10Show fewer
  • Severe respiratory or cardiac disorders.
  • Advanced liver or kidney disease.
  • Pregnancy.
  • Physical status ASA IV and Male patients.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • National cancer Insititute Cairo university

    Cairo, 11796

Other trials in Egypt

About this study

Official title: Analgesic Efficacy of Ultrasound-guided Retrolaminar Block and Erector Spinae Plane Block in Modified Radical Mastectomy: A Randomized Controlled Study

Modified radical mastectomy (MRM) is the most commonly performed surgical procedure in breast cancer patients and is usually associated with severe postoperative pain. The peripheral nerve block techniques were suggested to reduce acuter post-mastectomy pain. The study compared the analgesic efficacy of retrolaminar block (RLB) and ESPB in patients undergoing MRM.

Read the detailed description

Introduction Globally, breast cancer remains the most prevalent cancer among females, with an estimated incidence of 31% and mortality of 15%. Surgery is foremost in managing breast cancer, where modified radical mastectomy (MRM) is the most commonly performed procedure. This procedure implicates vigorous tissue dissection and seroma formation with many postoperative complications. Pain is the main complaint following MRM, affecting up to 50% of women, and 25-60% develop persistent chronic postmastectomy pain.

Therefore, adequate pain control is crucial to postoperative management after MRM. Numerous analgesic methods were suggested to reduce acuter post-mastectomy pain. Opioid-related adverse events include nausea and vomiting, respiratory depression, sedation, and dizziness.

Most mastectomy-related pain originates from the chest wall's sensory nerves. The peripheral nerve block techniques have gained increased interest in treating postoperative pain. The erector spinae plane block (ESPB) is one of these techniques that proved effective in various surgical procedures, including breast surgery. It encompasses injecting the local anesthetic (LA) solution deep into the erector spinae muscle (ESM), which eventually spreads through the paravertebral space. Ultrasound-guided retrolaminar block (RLB) is another approach that was found to be effective for pain relief after thoracic surgery. In RLB, LA is injected into the space between the ESM and the lamina of the thoracic vertebra.

Both techniques are considered variants of paravertebral block; however, prospective studies comparing RLB and ESPB are limited. Therefore, this study was designed to compare the analgesic efficacy of ultrasound-guided retrolaminar block and erector spinae plane block in patients undergoing modified radical mastectomy.

Patients and Methods:

This randomized single-blinded study was conducted at the National Cancer Institute (NCI), Cairo University from October 2022 and finished March 2023. The study was approved by the institutional review board and the scientific committee of the anesthesia department of the NCI and Faculty of Medicine, Cairo University. All participants provided written informed consent before enrollment in the study after fully explaining the procedures and possible complications.

The study involved 60 female patients scheduled for MRM under general anesthesia with the following inclusion criteria: age 18 to 65, ASA class II or III, and body mass index (BMI) of 20-35 kg/m2. Patients with known sensitivity or contraindication to the drugs used in the study, history of psychological disorders or chronic pain syndromes, contraindication to regional anesthesia (local sepsis, pre-existing peripheral neuropathies, coagulopathy), severe respiratory or cardiac conditions, advanced liver or kidney disease were excluded from the study.

The patients were randomly allocated into one of two equal groups using computer-generated random numbers in opaque closed envelopes. An independent statistician performed the randomization. The grouping was revealed only when the patient was transferred to the pre-anesthetic room. The RLB Group (n=30) received a preoperative ultrasound-guided retrolaminar block using 20 ml levobupivacaine 0.25%. The ESPB Group (n=30) received a preoperative ultrasound-guided erector spinae plane block using 20 ml levobupivacaine 0.25%.

Preoperative assessment included thorough history taking, physical examination, and laboratory and radiological investigations. The patients were instructed to report pain using the Numeric Pain Rating Scale (NPRS), where 0 = no pain and 10 = worst imaginable pain. All patients were premedicated with IV midazolam 0.01-0.02 mg/kg 30 minutes before surgery. In both blocks, a Fujifilm Sonosite M-Turbo Ultrasound system linear probe was used (SN.04RQZ6) . After performing blocks lung ultrasound was performed to exclude pneumothorax.

Retrolaminar Block Technique The block was performed under complete aseptic precautions. The ultrasound probe was placed on the back in a transverse orientation on the lateral side of the posterior median line to identify the lamina of the 5th vertebra, ESM, and transversospinalis muscles of the target segment. A skin wheal using 3 ml of 1% lidocaine was made 2-3 cm medial to the transducer. A 38-mm 22-gauge regional block needle was advanced using an in-plane technique. When the puncture needle touched the lamina, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% levobupivacaine was administered between the transversospinalis muscle and lamina. The LA diffusion between the lamina and the ESM indicated a successful puncture.

Erector spinae plane block:

The ultrasound probe was placed on the back in a transverse orientation to identify the tip of the T5 transverse process as flat, squared-off acoustic shadows with a faint image of the pleura visible. When the tip of the transverse process was centered on the ultrasound screen, the probe was rotated to a longitudinal orientation. In the parasagittal view, the following layers were visible superficial to the acoustic shadows of the transverse processes: skin and subcutaneous tissue, trapezius, ESM, and T5 transverse process. A skin wheal was made using 3 ml of 1% lidocaine; then, the block needle was inserted in-plane in a cranial-to-caudal direction until contact was made with the T5 transverse process. The correct location of the needle tip in the fascial plane deep to the ESM was confirmed by injecting 0.5-1.0 ml of normal saline and seeing the fluid lifting the ESM off the transverse process without distending the muscle. After aspiration to avoid intravascular injection, 20 ml levobupivacaine 0.25% was injected.

Anesthetic Management:

All patients were monitored continuously using electrocardiography, non-invasive blood pressure, peripheral O2 saturation, temperature probe, and end-tidal CO2 throughout the surgical procedure. Anesthesia was induced using fentanyl 2 μg/kg and propofol 2 mg/kg IV. Tracheal intubation was facilitated using rocuronium 0.5 mg/kg IV. Anesthesia was maintained with inhaled sevoflurane 2.0-2.5% in oxygen-enriched air (FiO2=0.5). Maintenance doses of rocuronium 0.1 mg\kg were provided every 30 minutes. Paracetamol 500 mg and ketorolac 30 mg were provided as a part of multimodal analgesia. Rescue analgesia of fentanyl 1 μg/kg was given if the mean arterial blood pressure (MAP) or heart rate (HR) rose above 20% of baseline levels. The patients were mechanically ventilated at appropriate settings to keep end-tidal CO2 at 30-35 mmHg.

The first reading of MAP and HR was taken before induction of general anesthesia as a baseline reading. Then, another reading was taken immediately before incision and at 30-minute intervals intraoperatively. Hypotension (reduction > 20% of baseline reading) was treated with 0.9% normal saline and/or 5 mg ephedrine in incremental doses to maintain MAP above 70 mmHg. The residual neuromuscular blockade was reversed using neostigmine 0.05 mg/kg and atropine 0.02 mg/kg. Extubation was performed after complete recovery of the airway reflexes.

Postoperatively the NPRS score, MAP, and HR were noted immediately on arrival and every 2 hours. Multimodal analgesia was provided as paracetamol 500 mg/6 hours and ketorolac 30 mg/8 hours IV. Rescue analgesia was provided as IV morphine 3 mg boluses when the patient indicated an NPRS score ≥ 4. The total amount of morphine given in 24 hours was recorded, and a maximum dose of 0.5 mg/kg/24 hours of morphine was allowed. Side effects such as nausea, vomiting, sedation, hallucination, and respiratory depression (respiratory rate < 10/minute) were recorded. Moderate or severe postoperative nausea and vomiting (PONV) was treated with 0.1 mg/kg of IV ondansetron.

Being tested
The Ultrasound-guided Retrolaminar Block Group, The Ultrasound-guided Erector Spinae Plane Block Group
Keywords
Analgesics, Opioids, Breast Neoplasms, Postoperative Pain, Mastectomy, Nerve block
Medical subject headings
Breast Neoplasms, Agnosia, Pain, Postoperative

What participants receive

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

  • The Ultrasound-guided Retrolaminar Block GroupProcedure or surgery

    Also called RLB

    The ultrasound probe was placed on the back in a transverse orientation on the lateral side of the posterior median line to identify the lamina of the 5th vertebra, ESM, and transversospinalis muscles of the target segment.

    A 38-mm 22-gauge regional block needle was advanced using an in-plane technique. When the puncture needle touched the lamina, 20 mL of 0.25% levobupivacaine was administered between the transversospinalis muscle and lamina. The LA diffusion between the lamina and the ESM indicated a successful puncture.

  • The Ultrasound-guided Erector Spinae Plane Block GroupProcedure or surgery

    Also called ESPB

    The ultrasound probe was placed on the back in a transverse orientation to identify the tip of the T5 transverse process as flat, squared-off acoustic shadows with a faint image of the pleura visible. When the tip of the transverse process was centered on the ultrasound screen, the probe was rotated to a longitudinal orientation. In the parasagittal view, the following layers were visible superficial to the acoustic shadows of the transverse processes: skin and subcutaneous tissue, trapezius, ESM, and T5 transverse process.

    The block needle was inserted in-plane in a cranial-to-caudal direction until contact was made with the T5 transverse process. The correct location of the needle tip in the fascial plane deep to the ESM was confirmed by injecting 0.5-1.0 ml of normal saline and seeing the fluid lifting the ESM off the transverse process without distending the muscle. Then 20 ml levobupivacaine 0.25% was injected.

Study groups in NCT06322316
Study groupRoleWhat they receive
The Ultrasound-guided Retrolaminar Block (RLB) GroupActive comparatorReceived a preoperative ultrasound-guided retrolaminar block using 20 ml levobupivacaine 0.25% Ultrasound probe was placed on the back in a transverse orientation on the lateral side of the posterior median line to identify the lamina of the 5th vertebra, ESM, and transversospinalis muscles of the target segment.
Receives: Procedure: The Ultrasound-guided Retrolaminar Block Group
The Ultrasound-guided Erector Spinae Plane Block (ESPB) GroupActive comparatorReceived a preoperative ultrasound-guided erector spinae plane block using 20 ml levobupivacaine 0.25%. ultrasound probe was placed on the back in a transverse orientation to identify the tip of the T5 transverse process as flat, squared-off acoustic shadows with a faint image of the pleura visible. When the tip of the transverse process was centered on the ultrasound screen, the probe was rotated to a longitudinal orientation. In the parasagittal view The block needle was inserted in-plane in a cranial-to-caudal direction until contact was made with the T5 transverse process.
Receives: Procedure: The Ultrasound-guided Erector Spinae Plane Block Group

What is being measured

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

  1. the total morphine consumed postoperatively for 24 hours

    the total morphine consumed postoperatively for 24 hours

    Measured: 24 hours

Secondary outcomes (3)
  1. the total intraoperative fentanyl consumption

    the total intraoperative fentanyl consumption when hemodynamics intraoperative >20%

    Measured: intraoperative

  2. duration of analgesia

    Duration of analgesia was defined as the time from the block performance to the first postoperative rescue analgesic administrated upon patient request

    Measured: at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively

  3. postoperative nausea and vomiting PONV as side effect of morphine

    nausea and vomiting scores using a four-point verbal scale

    Measured: at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively

Timeline

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

  1. First posted21 Mar 2024
  2. Study start1 Oct 2022
  3. Primary completion1 Mar 2023
  4. Study completion1 Apr 2023

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
To determine the analgesic effect of ultrasound guided Retrolaminar Block and Erector Spinae Plane Block in patients undergoing modified radical mastectomy regarding the following : 1-Post-operative opioid (morphine) consumption in the 1st 24 hours 2- Postoperative Numeric Pain Rating Scale. 3. Effect on hemodynamics: Mean arterial blood pressure and Heart rate. 4. Intraoperative fentanyl consumption. 5. Duration of analgesic effect
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06322316
Sponsor's protocol ID
MS-492-2022
Status last verified
Mar 2024
First submitted
5 Mar 2024
Last updated
21 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: till publication

Questions about this trial

What is this clinical trial studying?

A study testing The Ultrasound-guided Retrolaminar Block Group and The Ultrasound-guided Erector Spinae Plane Block Group in people with Breast Neoplasms and Analgesia, 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 5 inclusion and 10 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 21 Mar 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?

the total morphine consumed postoperatively for 24 hours (time frame: 24 hours). 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 21 Mar 2024.

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