Erector Spinae Catheter Versus Paravertebral Catheter for Postoperative Analgesia in Cancer Patients Post Mastectomies

Study Overview
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Brief Summary
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All patients admitted in National Cancer institute, Cairo University for breast surgeries will be investigated for inclusion criteria in the current study. And will be enrolled if fulfilled the criteria into 2 groups .70 patients will be included in this prospective randomized study. The patients will be allocated into two groups: the ESPB group (group E, n = 35) , and the paravertebral group (group P, n =35) All patients will do Ultrasound-guided ESPB for group E and PVB for group P before receiving general anesthesia Postoperatively Patients in both groups will receive intravenous morphine 3 mg as rescue analgesic

Detailed Description
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70patients will be included in this prospective randomized study. The patients will be allocated into two groups: the ESPB group (group E, n = 35) , and the paravertebral group (group P, n =35) All patients will do Ultrasound-guided ESPB for group E and PVB for group P before receiving GA Postoperatively Patients in both groups will receive intravenous morphine 3 mg as rescue analgesic. Random numbers were generated using a computer-generated randomization code and were sealed in an opaque envelope. Randomization was conducted by a person who was not involved in the study. An independent observer who was blind to the group assignment checked the intraoperative and postoperative data. VAS pain score immediately postoperative and at 2,4,6, 8,12,18,24,36 ,48hrs.postoperative.

Official Title
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Erector Spinae Catheter Versus Paravertebral Catheter for Pain Management in Modified Radical Mastectomy for Cancer Patients: A Randomized Double-Blind Non-inferiority Trial

Conditions
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Post Operative Pain

Intervention / Treatment
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* Procedure: ERECTOR SPINAE PLANE BLOCK and PARAVERTEBRAL BLOCK:
* Procedure: PARAVERTEBRAL BLOCK:


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: .Physical status ASA II. . Patients (age 20-70yrs) scheduled for breast surgeries for breast cancer under general anesthesia Exclusion Criteria: .History of psychological disorders. Known sensitivity or contraindication to local anesthetics. Localized infection at the site of block. patients with coagulopathy or an (INR ≥ 2)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Erecto Spinae Plane Block group<br>a high-frequency linear ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T7 spinous process. This should reveal three muscles superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. The skin will be anaesthetized using 3ml of 2% Lidocaine. A 20-gauge block needle will be inserted in-plane in a cephalad-to-caudad direction to place the tip into the fascial plane on the deep (anterior) aspect of erector spinaemuscle;20ml bupivacaine 0.25% will be injected. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process The needle will be removed and the catheter secured with adhesive. | Procedure: ERECTOR SPINAE PLANE BLOCK and PARAVERTEBRAL BLOCK:<br>* catheter will be placed for ERECTOR SPINAE PLANE BLOCK<br>Procedure: PARAVERTEBRAL BLOCK:<br>* catheter will be placed for PARAVERTEBRAL BLOCK<br>|
| Active Comparator: the paravertebral group<br>After identification of the transverse process, internal intercostal membrane (IIM), and pleura at the T3 and T6 levels, an out-of-plane needle guidance technique was used to perform the PVB.The success of both blocks will be confirmed by loss of pinprick sensation on the dermatomal site of the block •blocks will be activated ,After negative aspiration, 0.5 ml/kg 0.25% bupivacaine (max 20 ml) will be injected. Afterwards, a 20 gauge peripheral nerve catheter will be easily threaded into the space. The needle will be removed and the catheter secured with adhesive. | Procedure: ERECTOR SPINAE PLANE BLOCK and PARAVERTEBRAL BLOCK:<br>* catheter will be placed for ERECTOR SPINAE PLANE BLOCK<br>Procedure: PARAVERTEBRAL BLOCK:<br>* catheter will be placed for PARAVERTEBRAL BLOCK<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total 48 hours Post-operative opioid consumption to keep VAS score ≤4. | the VAS score rating, in which 0 = no pain and 10 = worst possible pain. both during rest and movement | 48 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1st request of analgesia | 1st request of analgesia , any hemodynamic instability and complications | 48 hours postoperative |