AzTrials
AzTrials

Serratus Anterior Plane BlockPhase 4NCT07649837

Comparison of the Analgesic Efficacy of Ultrasound-guided Retrolaminar Block Versus Serratus Anterior Plane Block in Patients Undergoing Radical Mastectomy

A Phase 4 study testing Serratus Anterior Plane Block (SAPB) group and Retrolaminar block group in people with Serratus Anterior Plane Block, run by Ain Shams University 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

All patients will be taught how to interpret the visual analogue scale (VAS) of 0 to 10 with 0 experiencing no pain and 10 being the worst pain imaginable. All patients will fast for 8 hours prior to surgery and will be allowed to consume clear fluids for up to 2 hours before surgery. Read more about this study

Who is it for?
Ages 25 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Serratus Anterior Plane Block
What is being tested?
Serratus Anterior Plane Block (SAPB) group and Retrolaminar block group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteEgypt
Study dates
17 May 2026to 15 Oct 2026
Phase
Phase 4
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 25 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • aged 25-65 years; (2) American Society of Anesthesiologists (ASA) physical status I or II; (3) Body mass index (BMI) between 18 and 28 kg/m2; (4) No known allergy to medications used in the study; and (5) Scheduled for modified radical mastectomy or radical mastectomy for breast cancer.

Who cannot join

  • (1) Patients with hepatic or renal dysfunction, severe hypertension, diabetes, coagulation disorders, cardiovascular diseases, or other critical illnesses; (2) Contraindications to regional nerve block, such as anatomical abnormalities of spine or thorax, or puncture site infection; (3) Allergy to narcotic drugs; (4) Pregnancy; (5) Chronic pain; (6) Chronic opioid use, substance abuse, or alcoholism; (7) Motion sickness; or (8) Communication disorder or inability to comprehend the visual analogue scale (VAS) scoring system.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ainshams University

    Cairo

Other trials in Egypt

About this study

All patients will be taught how to interpret the visual analogue scale (VAS) of 0 to 10 with 0 experiencing no pain and 10 being the worst pain imaginable. All patients will fast for 8 hours prior to surgery and will be allowed to consume clear fluids for up to 2 hours before surgery. On the day of surgery, a peripheral cannula will be inserted on the contralateral limb. Basic monitors will be attached to the patients (NIBP, ECG, pulse oxime try, ETCO2).

Then, either technique will be performed. Both RLB and SAPB procedures will be completed by experienced anesthesiologists specialized in regional anesthesia. In group SAPB under aseptic technique, a linear ultrasound transducer (10-12 MHz) will be attached to a Sonosite M Turbo (Sonosite Inc, Bothell, WA, USA) will be put in a sagittal plane over the second intercostal space in the midclavicular region, while the patient will lei supine. After that, the probe will be moved downward and laterally to count the ribs till the fifth rib will be detected in the midaxillary line. The following muscles will be delineated overlying the fifth rib: the latissimus dorsi (superficial and posterior), teres major (superior), and serratus muscle (deep and inferior). Targeting the plane between the latissimus dorsi and serratus anterior muscles, the needle (20 G Tuohy nee dle) will be inserted in plane with the ultrasound probe. A total of 20 ml of 0.25% bupivacaine will be administered under continuous ultrasound guidance [19]. For RLB, the ultrasound probe will be placed in a sagittal orientation on the lateral side of the posterior median line to identify the lamina, erector spine muscle, and transvers spinalis muscles at the target thoracic segment [12]. A 20G puncture needle will be inserted using an intra-plane technique in a cephalocaudal direction. Once the needle contact the lamina and aspiration reveals with no blood, gas, or cerebrospinal fluid, 20 mL of local anesthetic solution, comprising 20 mL of 0.25% bupivacaine will be administered between the transvers spinalis muscle and lamina.

Read more

Five minutes after nerve block, anesthesiologists will assess the block plane by acupuncture at the medial and lateral nipple lines from T2 to T6. The anesthesiologists performing the blocks also monitored block-related complications, including pneumothorax, hypotension, and vascular injury.

Induction of general anesthesia will be done by propofol until loss of verbal response, atracurium (0.5 mg/ kg), fentanyl (1mic/kg). Intubation of trachea will be done. Maintenance of anesthesia by using isoflurane (MAC1.2-1.5), mechanical ventilation (to keep ETCO2 35-40 mm. Hg), and atracurium top-up doses according to the train of four (TOF). All patients will be given fluids according to the standardized guidelines. An appropriate type of antibiotics and paracetamol (15 mg/kg) will be given at the start of surgery. Ondansetron IV (4-8 mg) and ketorolac IV (30 mg) will be given at the end of surgery.

Reversal of muscle relaxant will be done by using neostigmine (0.07 mg/kg) and atropine (0.01 mg/kg) and extubate the patient when having the criteria of extubation. Patients then will be transferred to the post- anesthesia care unit (PACU) for 2 hr for observation of any complications and early assessment of pain then will be transferred to the ward.

At the ward, patients will be given paracetamol (15 mg/kg) IV every 8 hr. Rescue analgesia in form of nalbuphine IV (6 mg/dose) when VAS score ≥4 at any time postoperatively during the first 24 hr.

Hemodynamics will be recorded (HR, MAP) throughout the first 24 hr at 30 min, 2 hr, 4 hr, 6 hr, 12 hr, 18 hr, and 24 hr together with pain assessment by using VAS score at rest and with the movement of the ipsilateral arm, time to first rescue analgesic (min), the total dose of rescue analgesia (mg) and frequency of consumption. Any technique-related complications will be detected and managed accordingly. Patients' satisfactions were taken by using the verbal rating scale (from 1 to 5). Patients then will be discharged home when they are eligible and ready.

The primary outcome will be the VAS scores during coughing at 6 hours after surgery. In addition, VAS scores at rest, during activity, and during coughing will be recorded at 1, 6, 12, 24 and 48 hours after the operation. If the postoperative resting VAS score exceeds 4, patients will receive 5 mg intravenous nalbuphine as rescue analgesia. Secondary outcomes will include the extent of sensory block (T2 to T6 at the medial and lateral nipple lines) assessed by pin-prick testing, intraoperative hemodynamic changes, and analgesia-related adverse reactions, such as postoperative nausea and vomiting (PONV), respiratory depression, and pulmonary atelectasis [20,21]. Follow-up will be completed after recording the VAS score and postoperative complications at 24 hours.

Read the detailed description

Breast cancer is one of the most diagnosed cancer worldwide. This resulted in improvements in screening techniques for early detection and management. Surgery, chemotherapy, radiation, and hormonal therapy are used to treat it. Modified radical mastectomy (MRM), either with or without axillary lymph node clearance, is one of the surgical options for treating breast cancer. This procedure results in a significant surgical scar and intense pain after surgery. It is imperative that this pain be effectively handled so that no negative out comes result.

Adverse effects of postoperative pain affect almost all of the body systems. It is associated with anxiety, depression, and psychological disturbance. It causes hemodynamic changes and affects the lungs with atelectasis and respiratory depression as a result of the excessive use of narcotic painkillers. Along with possible occurrence of limb edema, it results in delayed upper limb mobility as well leading to an increase in hospital costs and a delay of the hospital discharge. This acute pain can develop into the chronic illness known as post-mastectomy pain syndrome , a kind of nociceptive pain characterized by burning, itching, paresthesia, or numbness sensations.

Managing acute postmastectomy pain includes pharmacological methods (opioids, paracetamol, NSAIDS, lidocaine, dexmedetomidine, clonidine, gabapentin, corticosteroid, NMDA receptor antagonists) . The non-pharmacological methods include thoracic epidural anesthesia (TEA), paravertebral block (PVB), peripheral nerve blocks like erector spinae plan block (ESPB), pectoral nerve block (PECS I, PECS II), and serratus anterior plane block (SAPB), and lastly, wound infiltration or local anaesthetic instillation via the surgical drain

RLB is a modified form of paravertebral block (PVB) . While PVB is increasingly used for chest and abdominal surgeries due to its precise analgesic effects, it carries a risk of serious complications, including pneumothorax, hypotension, or nerve damage . Even with ultrasound guidance, performing a traditional PVB remains technically challenging, with its success heavily reliant on the operator's expertise. RLB, as an improved alternative to PVB, has received growing attention in recent years. It involves the ultrasound-guided injection of local anesthetic between the lamina of the thoracic vertebra and the erector spinal muscle . Compared to PVB, RLB is easier to perform, associated with fewer complications such as pneumothorax, intrathecal injection, or vascular damage. However, the spread of anesthetic in RLB appears highly variable and is dose-dependent

The serratus anterior plane block (SAPB) targets the fascial plane between the lateral border of the pectoralis major and the serratus anterior muscle. Due to its myofascial space, SAPB typically requires only a single injection. It has been widely utilized for anesthesia in operations such as mastectomy, thoracotomy, thoracoscopic surgery, and rib fracture repair . Additionally, injecting the local anesthetic deep into the serratus anterior muscle has been found to simplify the procedure while maintaining comparable analgesic efficacy However, SAPB has certain limitations. Local anesthetic may diffuse extensively within the myofascial plane, potentially infiltrating the surgical field, which could interfere with the procedure and theoretically increase the risk of cancer cell dissemination.

Previous clinical studies have demonstrated that both RLB and SAPB can provide effective postoperative analgesia following breast surgery offering multiple options for regional anesthesia in thoracic procedures.

Although the precise mechanism of RLB remains unclear, cadaveric studies suggest that local anesthetic may diffuse into the paravertebral space via anatomical apertures, thereby blocking spinal nerves, while SAPB is thought to act by blocking the lateral cutaneous branches of the intercostal nerves

  1. AIM/ OBJECTIVES The newly introduced retrolaminar block (RLB) offers anesthesiologists an alternative regional anesthetic technique for radical mastectomy. However, few clinical studies have compared the efficacy of RLB with that of serratus anterior plane block (SAPB). This study aimed to investigate the postoperative analgesia efficacy between ultrasound-guided RLB and SAPB in patients undergoing radical mastectomy
Being tested
Serratus Anterior Plane Block (SAPB) group, Retrolaminar block group
Keywords
retrolaminar block, serratus anterior block

What participants receive

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

  • Serratus Anterior Plane Block (SAPB) groupOther

    In group SAPB under aseptic technique, a linear ultrasound transducer (10-12 MHz) will be attached to a Sonosite M Turbo (Sonosite Inc, Bothell, WA, USA) will be put in a sagittal plane over the second intercostal space in the midclavicular region, while the patient will lei supine. After that, the probe will be moved downward and laterally to count the ribs till the fifth rib will be detected in the midaxillary line. The following muscles will be delineated overlying the fifth rib: the latissimus dorsi (superficial and posterior), teres major (superior), and serratus muscle (deep and inferior). Targeting the plane between the latissimus dorsi and serratus anterior muscles, the needle (20 G Tuohy nee dle) will be inserted in plane with the ultrasound probe. A total of 20 ml of 0.25% bupivacaine will be administered under continuous ultrasound guidance

  • Retrolaminar block groupOther

    For RLB, the ultrasound probe will be placed in a sagittal orientation on the lateral side of the posterior median line to identify the lamina, erector spine muscle, and transvers spinalis muscles at the target thoracic segment [12]. A 20G puncture needle will be inserted using an intra-plane technique in a cephalocaudal direction. Once the needle contact the lamina and aspiration reveals with no blood, gas, or cerebrospinal fluid, 20 mL of local anesthetic solution, comprising 20 mL of 0.25% bupivacaine will be administered between the transvers spinalis muscle and lamina.

Study groups in NCT07649837
Study groupRoleWhat they receive
serratus anterior groupActive comparatorfor serratus anterior block in patients with modified radical mastectomy
Receives: Other: Serratus Anterior Plane Block (SAPB) group
retrolaminar block groupActive comparatorretrolaminar block for patients with modified radical mastectomy
Receives: Other: Retrolaminar block group

What is being measured

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

  1. visual analogue score

    from zero (no pain) to 10 the worst pain

    Measured: 6 hours after surgery during coughing

Secondary outcomes (1)
  1. extene of sensory block

    Five minutes after nerve block, anesthesiologists will assess the block plane by acupuncture at the medial and lateral nipple lines from T2 to T6

    Measured: 5 minutes after the block

Timeline

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

  1. First posted16 Jun 2026
  2. Study start17 May 2026
  3. Primary completion30 Sep 2026
  4. Study completion15 Oct 2026

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07649837
Sponsor's protocol ID
FMASU R103/2026
Status last verified
Oct 2026
First submitted
4 Jun 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Serratus Anterior Plane Block (SAPB) group and Retrolaminar block group in people with Serratus Anterior Plane Block, run by Ain Shams 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 1 inclusion and 1 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 4 Nov 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

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?

visual analogue score (time frame: 6 hours after surgery during coughing). 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 4 Nov 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