Modified Pectoral Nerves Block Versus Serratus Plane Block in Major Breast Cancer Surgery

Study Overview
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Brief Summary
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The purpose of this study is to compare the analgesic profile of modified pectoral nerves block and serratus plane block in patients undergoing mastectomy.

Detailed Description
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This study includes three groups. The first group will receive ultrasound-guided modified pectoral nerves block prior to induction of general anesthesia. The second one will receive ultrasound-guided serratus plane block prior to induction of general anesthesia. The third one will not receive any block preoperatively.

Official Title
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A Comparative Study for Evaluation of the Analgesic Profile of Ultrasound-Guided Modified Pectoral Nerves Block Versus Serratus Plane Block in Major Breast Cancer Surgery

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Bupivacaine 0.25% with epinephrine
* Drug: Bupivacaine 0.25% with epinephrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists( ASA) I or II and scheduled for major breast cancer surgery( modified radical mastectomy or conservative mastectomy with axillary evacuation). Exclusion Criteria: Local infection at the site of the block, coagulations abnormalities, allergy to local anesthetics or morphine, body mass index> 35, patient refusal, severe respiratory or cardiac disorders, pre-existing neurological deficits, hepatic or renal insufficiency, chronic pain syndrome, chronic analgesic use and psychiatric disorders.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: modified pectoral nerves block<br>Modified pectoral nerves block with general anesthesia. Using the ultrasound, 10 ml of bupivacaine 0.25% with epinephrine 5 ug/ml will be injected in the plane between the pectoralis major and minor muscles. And another 20 ml of bupivacaine 0.25% with epinephrine 5 ug/ml will be injected in the plane between the pectoralis minor and the serratus anterior muscles. | Drug: Bupivacaine 0.25% with epinephrine<br> <br> * Other names: Markyrene;|
| Active Comparator: serratus plane block<br>Serratus plane block with general anesthesia. Using the ultrasound, 0.4 ml of bupivacaine 0.25% with epinephrine 5 ug/ml will be injected in the plane between the serratus anterior muscle and the underlying ribs. | Drug: Bupivacaine 0.25% with epinephrine<br> <br> * Other names: Markyrene;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fentanyl consumption |  | Intraoperative | 
| Total morphine consumption |  | The first 24 hours postoperative | 
| Visual analogue scale score at rest and during shoulder movement |  | The first 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean arterial blood pressure | Hemodynamics | Preincision, 1 minute postincision, 1 hour postincision, 4, 8, 12, 24 hours postoperative | 
| Heart rate | Hemodynamics | Preincision, 1 minute postincision, 1 hour postincision, 4, 8, 12, 24 hours postoperative | 
| Time to first requirement of rescue analgesia |  | The first 24 hours postoperative | 
| Sedation score | as a side effect of morphine | Immediate postoperative, 1, 4, 8, 12, 24 hours postoperative | 
| Respiratory rate | respiratory depression defined as respiratory rate <12 breaths per minute | Immediate postoperative, 1, 4, 8, 12, 24 hours postoperative | 
| Nausea and vomiting | as a side effect of morphine | The first 24 hours postoperative | 
| Patient satisfaction with postoperative analgesia | using numerical rating scale from 0 to 10 | One week after surgery |