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

NCT07649837 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: FMASU R103/2026
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Serratus Anterior Plane Block

Keywords

retrolaminar block; serratus anterior block

Outcome Measures

Primary Outcomes (1)

• visual analogue score

  from zero (no pain) to 10 the worst pain

  6 hours after surgery during coughing

Secondary Outcomes (1)

• extene of sensory block

  5 minutes after the block

Study Arms (2)

serratus anterior group

ACTIVE COMPARATOR

for serratus anterior block in patients with modified radical mastectomy

Other: Serratus Anterior Plane Block (SAPB) group

retrolaminar block group

ACTIVE COMPARATOR

retrolaminar block for patients with modified radical mastectomy

Other: Retrolaminar block group

Interventions

Serratus Anterior Plane Block (SAPB) group OTHER

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

serratus anterior group

Retrolaminar block group OTHER

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.

retrolaminar block group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ainshams University

Cairo, Egypt

Location

MeSH Terms

Interventions

Saposins; Population Groups

Intervention Hierarchy (Ancestors)

Sphingolipid Activator Proteins; Coenzymes; Enzymes and Coenzymes; Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant proffesor of anaesthesia

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 16, 2026
• Study Start: May 17, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-05

Locations

EG (1)