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

Efficacy of the Mid-point Transverse Process to Pleura Block Versus Serratus Anterior Plane Block for Postoperative Analgesia After Modified Radical Mastectomy as a Randomized Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06625879
Enrollment
30
Registered
2024-10-03
Start date
2024-11-01
Completion date
2025-11-01
Last updated
2026-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

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.

Interventions

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.

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 .

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 60 Years
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Time to first rescue analgesia24 hours postoperativelyTime to first rescue analgesia was recorded from the end of surgery to first diclofenac administration.

Secondary

MeasureTime frameDescription
The total number of doses of the rescue analgesia24 hours postoperativelyThe 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).
Degree of pain24 hours postoperativelyPain 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.
Objective Pain Score24 hours postoperativelyObjective 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).
Heart rate24 hours postoperativelyHeart rate was recorded at baseline, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperatively.
Mean arterial pressure24 hours postoperativelyMean arterial pressure was recorded at baseline, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperatively.
Incidence of adverse events24 hours postoperativelyIncidence of adverse events such as nausea and vomiting were recorded.
Incidence of block-related complications24 hours postoperativelyIncidence of block-related complications such as local anesthetic toxicity and pneumothorax were recorded.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 8, 2026