- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06187909
PECS II vs. MTP for Analgesia After MRM
Ultrasound-Guided Modified Pectoral Plane (PECS II) Block Versus Midpoint Transverse Process to Pleura (MTP) Block for Postoperative Analgesia of Modified Radical Mastectomy
Study Overview
Status
Intervention / Treatment
Detailed Description
Modified radical mastectomy (MRM) is associated with significant postoperative pain, which may increase opioid use, delay recovery, and contribute to chronic post-mastectomy pain syndrome. This study compares two regional analgesic techniques: the ultrasound-guided modified pectoral nerve block (PECS II) and the midpoint transverse process to pleura (MTP) block.
The PECS II block involves the injection of local anesthetic between the pectoralis minor and serratus anterior muscles, targeting the pectoral nerves and lateral cutaneous branches of intercostal nerves (T2-T6). It is widely used for anterior chest wall analgesia after breast surgery. The MTP block, a more recent paravertebral-domain technique, deposits anesthetic midway between the transverse process and the pleura, allowing spread to dorsal and ventral rami via the superior costotransverse ligament and potentially achieving broader thoracic segment coverage.
This randomized trial evaluates postoperative pain control using the Visual Analog Scale (VAS) over 24 hours, along with opioid consumption and adverse events. The aim is to determine whether the MTP block offers superior analgesia and an opioid-sparing effect compared to the PECS II block.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt
- Ain Shams University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female patients scheduled for modified radical mastectomy (MRM).
- Age between 40 and 65 years.
- American Society of Anesthesiologists (ASA) physical status I-II.
Exclusion Criteria:
- Known allergy to local anesthetics.
- Coagulopathy.
- Infection at the site of injection.
- Patient refusal.
- Inability to understand or use the pain scale.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: PECS II block group
Forty-four female patients (ASA I-II, 40-65 years) scheduled for modified radical mastectomy received an ultrasound-guided PECS II block with 20 mL of 0.25% bupivacaine (10 mL between pectoralis major and minor; 10 mL between pectoralis minor and serratus anterior).
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In the supine position, as described by Blanco et al., the ultrasound probe was placed transversely beneath the clavicle.
After identifying the intermuscular plane between the pectoralis major and minor, 10 mL of 0.25% bupivacaine was injected.
The probe was then repositioned laterally to identify the plane between the pectoralis minor and serratus anterior at the third to fourth ribs, where a further 10 mL of 0.25% bupivacaine was injected.
|
|
Active Comparator: MTP block group
Forty-four female patients (ASA I-II, 40-65 years) scheduled for modified radical mastectomy received an ultrasound-guided midpoint transverse process to pleura (MTP) block with 20 mL of 0.25% bupivacaine (10 mL injected at T2 and 10 mL at T6).
|
The block was performed with the patient in a seated position.
The ultrasound probe was positioned parasagittally, approximately 3 cm lateral to the midline, at the T2 and T6 vertebral levels.
A 22-gauge needle was advanced in-plane to the midpoint between the transverse process and pleura, and 10 mL of 0.25% bupivacaine was injected at each level.
This protocol was adapted from the original technique described by Bhoi et al., with modifications in injection levels and volume.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-operative Pain Severity Assessed by VAS at Hour-4
Time Frame: will be evaluated at hour-4 postoperatively
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Visual Analogue Scale is a scale for pain assessment ranging from 0 to 10 where 0 is minimum and means no pain while 10 is maximum and means maximum pain which means worse outcome
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will be evaluated at hour-4 postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time of First Rescue Analgesia
Time Frame: 24 hours postoperatively
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Comparison between both groups regarding the time of first needed dose of nalbuphine
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24 hours postoperatively
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Cumulative Post-operative Nalbuphine Consumption in the First 24 Hours
Time Frame: 24 hours postoperatively
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Comparison between both groups regarding total consumed nalbuphine in first 24 hours postoperative
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24 hours postoperatively
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Incidence of Postoperative Side Effects and Complications
Time Frame: 24 hours postoperatively
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Comparison between both groups regarding postoperative side effects and complications
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24 hours postoperatively
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Post-operative Pain Severity Assessed by VAS on Admission to Postanesthesia Care Unit (PACU), at Hour-2, Hour-8, Hour-12, Hour-18 and Hour-24.
Time Frame: 24 hours postoperatively
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Comparison between postoperative pain severity after 2 hours, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours postoperative between both groups using visual analogue score Visual Analogue Scale is a scale for pain assessment ranging from 0 to 10 where 0 is minimum and means no pain while 10 is maximum and means maximum pain which means worse outcome
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24 hours postoperatively
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmed A. Khalifa, MD, Ain Shams University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Nervous System Diseases
- Postoperative Complications
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Neurobehavioral Manifestations
- Skin Diseases
- Breast Diseases
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Skin and Connective Tissue Diseases
- Signs and Symptoms
- Pain, Postoperative
- Breast Neoplasms
- Agnosia
Other Study ID Numbers
- FMASU MD311/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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