Clinical trial NCT06888258: Compare Analgesia Between MTP Block And ESPB in MRM
Official title: Comparative Study Between Ultrasound Guided Mid-point Transverse Process to Pleura Block And Erector Spinae Plane Block For Perioperative Analgesia In Modified Radical Mastectomy In Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is conducted to compare the analgesic efficacy between ultrasound guided Erector Spinae Plane block Vs midpoint transverse process to Pleura block in modified radical mastectomy surgeries

Detailed description: Patients participants will be randomized into 3 groups:

Group M (mid-point transverse process to pleura block MTP) N=3o Patients will receive Ultrasound guided mid-point transverse process to pleura block preoperative with injection of 20 ml bupivacaine 0.25%.

Group M: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse processes of the 4th and 5th thoracic vertebrae and pleura.

A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. Using the in plane needling technique in the space between the transverse processes of the 4th and 5th thoracic vertebrae, the puncture needle needle tip will be placed at the mid-point between the transverse process and pleura, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% bupivacaine will be administered. The local anesthetic spread will be noted in the area midway between the transverse process and pleura is an indication of a successful puncture.

Group E (Erector Spinae Plane Block ESB) N=3o Patients will receive Ultrasound guided erector spinae plane block with injection of 20 ml bupivacaine 0.25%.

Group E: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse process of the 5th thoracic vertebra and erector spine muscle.

A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. The puncture will be performed using the intra-plane needling technique after local anaesthesia infiltration. A 20-gauge Tuohy needle connected to a syringe containing the anesthetic mixture or saline will be advanced. When the puncture needle touch the transverse process, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% bupivacaine will be administered between the erector spine muscle and transverse process.

Local anesthetic diffusion between the transverse process and erector spinae muscle is an indication of a successful puncture.

Group C (control group) N=30 Patients will not receive any block. Induction will be performed by using a regimen of IV by fentanyl 1 μg/kg, Additional bolus doses of fentanyl 0.5 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.

Randomization will be done by statistician and each group of the patient will revealed only when the included patient is transferred to preanesthetic room.

Eligibility criteria: Inclusion Criteria:

* ASA I-II.
* Undergoing modified radical mastectomy surgery.
* Body mass index (BMI) from 18.5 to 30 kg/m2

Exclusion Criteria:

* Patient refusal.
* Known allergy to local anesthetics.
* Bleeding disorders; platelets count \<50,000 , prothrombin concentration \< 60% or any coagulopathy disorder.
* Use of any anti-coagulants.
* Inability to provide informed consent.
* ASA III-IV.
* Neurological disorders.
* Patient with psychiatric disorders

Primary outcomes:
measure: post-operative opioid (morphine) consumption in the 1st 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Time to first rescue analgesia, starting after extubation. In minutes
timeFrame: 24 hours
measure: Total dose of fentanyl required intraoperative (including induction dose) in microgram
timeFrame: 24 hours
measure: Numerical pain rating score at 15, 30, 45 and 60 min., 3,6,12 and 24 h after surgery. Score from 0 to 10 where 10 is the worst pain
timeFrame: 24 hours
measure: Change in heart rate (rate per minute) intraoperatively at 30 minutes interval in comparison to baseline reading.
timeFrame: 24 hours
measure: Change mean arterial blood pressure (mmHg) intraoperatively at 30 minutes interval in comparison to baseline reading.
timeFrame: 24 hours
measure: Heart rate (per minute) at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively
timeFrame: 24 hours
measure: Mean arterial blood pressure (mmHg) at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National cancer institute, Cairo University
Study officials:
affiliation: National cancer institute, Cairo University
name: Maie Kamal El-Din Helaly, MD
role: STUDY_DIRECTOR
References: