CClinicalTrials.gg
CompletedNCT06625879Updated Oct 7, 2026

Mid-point Transverse Process to Pleura Block VS Serratus Anterior Plane Block for Postoperative Analgesia After Modified Radical Mastectomy

An interventional study of Serratus Anterior Plane Block (SAPB) and Midpoint transverse process to pleura (MTP) block in Modified Radical Mastectomy, Postoperative Analgesia and Mid-point Transverse Process to Pleura Block, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 35 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

Updated Oct 7, 2026Now CompletedFirst site in Egypt+6 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
35 Years to 60 Years
Sex
Female
01

Study summary

This study aimed to compare the analgesic efficacy of ultrasound-guided mid-point transverse process-to-pleura block versus serratus anterior plane block after unilateral modified radical mastectomy.

Read the detailed description

Breast cancer is the most common cancer in women both in the developed and less developed world. In 2012, it represented about 12 percent of all new cancer cases and 25 percent of all cancers in women.

After the application of ultrasound in anaesthetic practice, several blocks have been described recently, Serratus anterior plane blocks performed at the axillary fossa within a region bounded by the anterior and posterior axillary lines and th 3rd to 6th ribs, in which the intercostobrachialis nerve, lateral cutaneous branches of the intercostal nerves (T2-T9),long thoracic nerve, and the thoracodorsal nerve are located in a compartment between the serratus anterior and the latissimus dorsi muscles.

The MTP block is a new block described for thoracic surgery, it involves deposition of the local anesthetic drug midway between the transverse process and the pleura. Postulated that the local anesthetic deposited at this point will reach the paravertebral space through several possible mechanisms, such as medially through the gap between the superior costotransverse ligament (SCTL) and vertebral bodies, through fenestrations in SCTL, and laterally through the internal intercostal membrane, the neural target will be the dorsal and ventral rami of spinal nerves, spanning 1-3 levels cranial and caudal to the level of injection, the advantage of the MTP block over the conventional thoracic paravertebral block is that the visualization of SCTL is not required, which might be difficult in patients with obesity. The second advantage is that the target point of the needle is very superficial and far from structures, such as the pleura and neurovascular bundles ,making this novel block much safer.

02

Conditions studied

  • Modified Radical Mastectomy
  • Postoperative Analgesia
  • Mid-point Transverse Process to Pleura Block
  • Serratus Anterior Plane Block
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Female patients undergoing unilateral Modified Radical Mastectomy. Physical status: ASA grades I and II. Age between 35 and 60 years old.

Exclusion criteria

Exclusion Criteria:

  • Known Allergy to one of the study drugs. Asthmatic patients. Patients undergoing bilateral Modified Radical Mastectomy. Patients refusal of procedure or participation in the study. ASA classes III or above. Local skin infection at the site of the block. Pregnant Patients. Other malignancy. History or evidence of coagulopathy. History of use of anti coagulant or anti platelet therapy. Body mass index ≥40 kg/m2.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Group I: (Serratus Anterior Plane Block (SAPB) Group) (n=15)

    Group I: (Serratus Anterior Plane Block (SAPB) Group) (n=15): The patient will lay on her side with arm brought forward, the linear US transducer probe (10-12 MHz) will be placed in the midaxillary line and then moved caudal from second rib until the sixth intercostal space. At this point, the subcutaneous tissue and serratus muscle will be identified in the superficial plane, whereas the external intercostal muscles will be identified in the intermediate plane and finally in the deep plane the ribs, pleura and lung will be identified. The needle will be advanced from caudal to cranial direction. In-plane technique will be used until the tip of the needle placed between the serratus anterior muscle and the external intercostal muscle (deep SABP) (Blanco et al., 2013). A volume of titrated bolus of 20 ml of bupivacaine 0.5% will be injected after aspiration to avoid intravascular injection (Lin J et al., 2020).

    Procedure: Serratus Anterior Plane Block (SAPB)

  • Active comparator
    GroupII: (Midpoint transverse process to pleura (MTP) block group )(n=15)

    GroupII: (Midpoint transverse process to pleura (MTP) block group )(n=15): In the lateral postion, the T4 spine will be counted by ultrasound, and high frequency linear US transducer probe (10-12 MHz) will be placed longitudinally, approximately 2.5 cm lateral to the midline the needle will be advanced in plane from cranial to caudal direction. The desired end point for the needle tip will be the midpoint of the line between the posterior border of the transverse process of T4 and the pleura(injection will be deep (anterior) to the posterior aspect of the vertebral transverse process but superficial to the superior costotransverse ligment),the needle tip dose not enter the paravertebral space (Chin et al., 2021), a volume of titrated bolus of 20 ml of bupivacaine 0.5% will be injected after aspiration to avoid intravascular injection,pleural displacement and bowing of erector spinae will be observed at the side of injection (Syal et al., 2020; Pusch et al., 2000).

    Procedure: Midpoint transverse process to pleura (MTP) block

Interventions

  • ProcedureSerratus Anterior Plane Block (SAPB)

    Group I: (Serratus Anterior Plane Block (SAPB) Group) (n=15): The patient will lay on her side with arm brought forward, the linear US transducer probe (10-12 MHz) will be placed in the midaxillary line and then moved caudal from second rib until the sixth intercostal space. At this point, the subcutaneous tissue and serratus muscle will be identified in the superficial plane, whereas the external intercostal muscles will be identified in the intermediate plane and finally in the deep plane the ribs, pleura and lung will be identified. The needle will be advanced from caudal to cranial direction. In-plane technique will be used until the tip of the needle placed between the serratus anterior muscle and the external intercostal muscle (deep SABP) . A volume of titrated bolus of 20 ml of bupivacaine 0.5% will be injected after aspiration to avoid intravascular injection.

  • ProcedureMidpoint transverse process to pleura (MTP) block

    In the lateral postion, the T4 spine will be counted by ultrasound, and high frequency linear US transducer probe (10-12 MHz) will be placed longitudinally, approximately 2.5 cm lateral to the midline the needle will be advanced in plane from cranial to caudal direction. The desired end point for the needle tip will be the midpoint of the line between the posterior border of the transverse process of T4 and the pleura(injection will be deep (anterior) to the posterior aspect of the vertebral transverse process but superficial to the superior costotransverse ligment),the needle tip dose not enter the paravertebral space , a volume of titrated bolus of 20 ml of bupivacaine 0.5% will be injected after aspiration to avoid intravascular injection,pleural displacement and bowing of erector spinae will be observed at the side of injection .

06

What researchers measure

Primary outcomes

  1. Time to first rescue analgesia

    Time to first rescue analgesia was recorded from the end of surgery to first diclofenac administration.

    Time frame: 24 hours postoperatively

Secondary outcomes

  1. The total number of doses of the rescue analgesia

    The total number of doses of the rescue analgesia that was received in the 24 hours postoperatively if the NRS pain score at rest ≥4, Numeric Rating Scale (NRS) at rest and at movement (cough or rotating the body).

    Time frame: 24 hours postoperatively

  2. Degree of pain

    Pain was assessed using an 11-point Numeric Rating Scale (NRS) (0=no pain, 1-3 mild, 4-7 moderate, 7-10 severe) at rest and during movement. Pain scores were recorded at 0, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperatively.

    Time frame: 24 hours postoperatively

  3. Objective Pain Score

    Objective Pain Score (OPS) was used to assess the degree of pain (1=inadequate pain relief/pain at rest; 2=pain-free at rest but pain with deep breathing; 3=pain-free with deep breathing but pain with coughing; 4=pain-free even with coughing).

    Time frame: 24 hours postoperatively

  4. Heart rate

    Heart rate was recorded at baseline, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperatively.

    Time frame: 24 hours postoperatively

  5. Mean arterial pressure

    Mean arterial pressure was recorded at baseline, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperatively.

    Time frame: 24 hours postoperatively

  6. Incidence of adverse events

    Incidence of adverse events such as nausea and vomiting were recorded.

    Time frame: 24 hours postoperatively

  7. Incidence of block-related complications

    Incidence of block-related complications such as local anesthetic toxicity and pneumothorax were recorded.

    Time frame: 24 hours postoperatively

07

Study locations

1 site
  • Ain Shams University
    Cairo, 11591, Egypt
08

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Completed
changed Oct 7, 2026
Sites
1 site added — first site in Egypt
Show site
  • Ain Shams University · Cairo, Egypt
Oct 7, 2026
Start date
Oct 2024→Nov 1, 2024 (actual)
Oct 7, 2026
Primary completion
Dec 2024→Nov 1, 2025 (actual)
Oct 7, 2026
Study completion
Jun 2025→Nov 1, 2025 (actual)
Oct 7, 2026
Also revised
primary outcomes
Show all 1 update
  1. Oct 7, 2026
    Not yet recruiting→Completed
    1 site added — first site in Egypt
    Show site
    • Ain Shams University · Cairo, Egypt
    Start date Oct 2024→Nov 1, 2024 (now actual)
    Primary completion Dec 2024→Nov 1, 2025 (now actual)
    Study completion Jun 2025→Nov 1, 2025 (now actual)
    Primary outcomes Revised (2 changes)
    + 7 other changes: index terms, identifiers, verification date, description, conditions, secondary outcomes and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06625879
Lead sponsor
Ain Shams University
Responsible party
Alaa Ashraf Hassan Abd Elsalam (Dr, Ain Shams University) — Principal investigator
First posted
Oct 3, 2024
Start date
Nov 1, 2024
Primary completion
Nov 1, 2025
Completion
Nov 1, 2025
Last update
Oct 7, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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